All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

buprenorphine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
opioid receptor antagonists/agonists, morphinan derivates	434	52485-79-7

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: buprenorphine buprenorfine norspan buprenorphine hydrochloride buprenorphine HCl

A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use. Molecular weight: 467.65 Formula: C29H41NO4 CLOGP: 3.99 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 62.16 ALOGS: -4.44 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
1.20	mg	P
1.20	mg	SL
1.20	mg	TD
1.60	mg	implant
2.10	mg	P
8	mg	SL
8	mg	SL

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	17 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	1 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.04 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	28 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	4.90 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	19 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.04 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	3.20 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
June 19, 2019	EMA	L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
Dec. 29, 1981	FDA	RECKITT BENCKISER

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Application site pruritus	1723.75	12.70	407	34522	3577	63450516
Product adhesion issue	1716.21	12.70	419	34510	4300	63449793
Drug withdrawal syndrome	1527.96	12.70	571	34358	26623	63427470
Application site erythema	1212.11	12.70	319	34610	4516	63449577
Application site rash	944.63	12.70	229	34700	2269	63451824
Inadequate analgesia	707.98	12.70	188	34741	2755	63451338
Application site pain	704.83	12.70	202	34727	3980	63450113
Application site vesicles	701.65	12.70	162	34767	1273	63452820
Application site burn	559.81	12.70	122	34807	712	63453381
Drug abuse	543.10	12.70	391	34538	72127	63381966
Drug withdrawal syndrome neonatal	515.13	12.70	136	34793	1945	63452148
Drug dependence	403.00	12.70	218	34711	24265	63429828
Application site irritation	374.73	12.70	102	34827	1648	63452445
Maternal exposure during pregnancy	367.14	12.70	524	34405	219538	63234555
Foetal exposure during pregnancy	256.64	12.70	180	34749	31782	63422311
Wrong technique in product usage process	246.37	12.70	232	34697	62108	63391985
Exposure during pregnancy	243.87	12.70	360	34569	155187	63298906
Application site scar	236.17	12.70	48	34881	187	63453906
Substance abuse	233.75	12.70	91	34838	4716	63449377
Application site discharge	225.11	12.70	44	34885	133	63453960
Application site erosion	208.87	12.70	42	34887	153	63453940
Application site exfoliation	183.82	12.70	44	34885	410	63453683
Application site dryness	183.74	12.70	37	34892	136	63453957
Application site discolouration	167.16	12.70	46	34883	775	63453318
Blepharospasm	159.55	12.70	74	34855	5922	63448171
Withdrawal syndrome	156.72	12.70	111	34818	19886	63434207
Premature delivery	145.77	12.70	126	34803	30155	63423938
Application site urticaria	140.92	12.70	32	34897	231	63453862
Product solubility abnormal	125.21	12.70	37	34892	813	63453280
Abortion spontaneous	123.73	12.70	141	34788	47054	63407039
Toxicity to various agents	123.22	12.70	356	34573	246894	63207199
Taste disorder	119.16	12.70	81	34848	13581	63440512
Product physical issue	115.76	12.70	56	34873	4924	63449169
Overdose	113.96	12.70	217	34712	114861	63339232
Application site reaction	112.03	12.70	33	34896	717	63453376
Application site swelling	111.30	12.70	31	34898	547	63453546
Somnolence	110.81	12.70	279	34650	178406	63275687
Product packaging quantity issue	108.13	12.70	37	34892	1322	63452771
Product administered at inappropriate site	106.60	12.70	46	34883	3103	63450990
Epilepsy	99.77	12.70	97	34832	26968	63427125
Placental disorder	96.91	12.70	35	34894	1469	63452624
Respiratory depression	95.77	12.70	71	34858	13644	63440449
Hyperaesthesia	95.00	12.70	61	34868	9297	63444796
Placental hypertrophy	91.09	12.70	14	34915	0	63454093
Hyperhidrosis	88.40	12.70	188	34741	107648	63346445
Yawning	88.26	12.70	30	34899	1050	63453043
Drug screen positive	84.93	12.70	41	34888	3588	63450505
Therapeutic product effect increased	84.80	12.70	30	34899	1185	63452908
Drug delivery system removal	84.58	12.70	13	34916	0	63454093
Jaundice neonatal	80.75	12.70	27	34902	898	63453195
Inappropriate schedule of product administration	80.35	12.70	177	34752	103788	63350305
Drug detoxification	78.83	12.70	21	34908	311	63453782
Intentional product misuse	78.52	12.70	129	34800	60788	63393305
Arthropathy	77.88	12.70	17	34912	234775	63219318
Euphoric mood	76.15	12.70	42	34887	4845	63449248
Pemphigus	75.52	12.70	7	34922	183719	63270374
Synovitis	74.53	12.70	8	34921	186910	63267183
Maternal exposure during breast feeding	73.19	12.70	39	34890	4202	63449891
Injection site pain	72.52	12.70	195	34734	129605	63324488
Oral administration complication	72.32	12.70	16	34913	101	63453992
Treatment failure	71.11	12.70	12	34917	199031	63255062
Accidental exposure to product by child	70.32	12.70	26	34903	1167	63452926
Application site dermatitis	70.02	12.70	17	34912	169	63453924
Systemic lupus erythematosus	69.54	12.70	15	34914	208903	63245190
Abortion induced	69.23	12.70	52	34877	10190	63443903
Application site ulcer	68.45	12.70	15	34914	90	63454003
Drug screen negative	66.86	12.70	18	34911	278	63453815
Exposure via breast milk	66.21	12.70	29	34900	2028	63452065
Sinusitis	64.68	12.70	22	34907	226631	63227462
Application site scab	64.11	12.70	16	34913	180	63453913
Foetal growth restriction	64.01	12.70	44	34885	7509	63446584
Rhesus incompatibility	63.61	12.70	14	34915	86	63454007
Product physical consistency issue	63.39	12.70	21	34908	678	63453415
Infusion related reaction	63.18	12.70	28	34901	245493	63208600
Breakthrough pain	62.03	12.70	24	34905	1222	63452871
Alopecia	61.62	12.70	57	34872	337479	63116614
Hand deformity	60.66	12.70	8	34921	159449	63294644
Contraindicated product administered	60.60	12.70	22	34907	217626	63236467
Injection site extravasation	60.00	12.70	45	34884	8796	63445297
Drug use disorder	59.45	12.70	36	34893	4948	63449145
Accidental overdose	58.31	12.70	68	34861	23241	63430852
Joint swelling	56.71	12.70	58	34871	327608	63126485
Selective abortion	56.30	12.70	14	34915	155	63453938
Stress cardiomyopathy	55.19	12.70	44	34885	9406	63444687
Injection site infection	54.88	12.70	25	34904	1918	63452175
Fatigue	52.76	12.70	281	34648	887747	62566346
Application site haemorrhage	50.15	12.70	20	34909	1104	63452989
Hallucination	50.10	12.70	100	34829	54717	63399376
Swelling	49.65	12.70	47	34882	275331	63178762
Disturbance in attention	49.37	12.70	81	34848	38108	63415985
Pyrexia	49.23	12.70	117	34812	470361	62983732
Pericarditis	49.10	12.70	7	34922	131572	63322521
Hepatic enzyme increased	46.17	12.70	27	34902	202301	63251792
Defaecation disorder	45.96	12.70	17	34912	764	63453329
Device leakage	45.69	12.70	35	34894	7061	63447032
Diarrhoea	44.88	12.70	222	34707	715144	62738949
Injection site cellulitis	44.69	12.70	19	34910	1235	63452858
Miosis	44.58	12.70	35	34894	7318	63446775
Skin irritation	43.78	12.70	39	34890	9702	63444391
Suicidal ideation	43.45	12.70	102	34827	62319	63391774
Infection	42.62	12.70	38	34891	229135	63224958
Subchondral insufficiency fracture	41.81	12.70	9	34920	49	63454044
Nasopharyngitis	41.75	12.70	47	34882	254210	63199883
Dermatitis contact	41.59	12.70	40	34889	10968	63443125
Prescription drug used without a prescription	41.34	12.70	22	34907	2364	63451729
Poor feeding infant	41.24	12.70	13	34916	357	63453736
Product dispensing issue	41.10	12.70	11	34918	166	63453927
Alcohol abuse	40.63	12.70	21	34908	2125	63451968
Intentional underdose	40.26	12.70	20	34909	1862	63452231
Echocardiogram abnormal	39.53	12.70	18	34911	1380	63452713
Rheumatoid arthritis	39.44	12.70	49	34880	253770	63200323
Anti-cyclic citrullinated peptide antibody positive	39.35	12.70	8	34921	116204	63337889
Drug diversion	39.30	12.70	16	34913	932	63453161
Bradycardia foetal	39.15	12.70	13	34916	423	63453670
17 ketosteroids urine abnormal	39.04	12.70	6	34923	0	63454093
Application site odour	38.80	12.70	8	34921	34	63454059
Congenital coronary artery malformation	38.19	12.70	10	34919	138	63453955
Impaired reasoning	37.98	12.70	9	34920	80	63454013
Arthralgia	37.90	12.70	173	34756	569537	62884556
Glossodynia	37.88	12.70	26	34903	178850	63275243
Migraine	36.97	12.70	133	34796	103213	63350880
Vomiting	36.66	12.70	469	34460	559148	62894945
Abdominal discomfort	36.63	12.70	76	34853	320809	63133284
Respiratory arrest	36.60	12.70	65	34864	32580	63421513
Application site inflammation	36.54	12.70	12	34917	377	63453716
Musculoskeletal stiffness	36.30	12.70	29	34900	184589	63269504
Cough	35.42	12.70	67	34862	292676	63161417
Rheumatoid factor positive	35.25	12.70	3	34926	84403	63369690
Low birth weight baby	34.97	12.70	30	34899	7099	63446994
Application site induration	34.88	12.70	6	34923	6	63454087
Febrile neutropenia	34.64	12.70	11	34918	118438	63335655
Therapy naive	33.72	12.70	7	34922	31	63454062
Gastrointestinal disorder	33.68	12.70	15	34914	131224	63322869
White blood cell count decreased	32.53	12.70	18	34911	139086	63315007
Haemoglobin decreased	32.36	12.70	20	34909	145465	63308628
Helicobacter infection	32.23	12.70	6	34923	92779	63361314
Platelet count decreased	31.86	12.70	12	34917	116110	63337983
Duodenal ulcer perforation	31.70	12.70	5	34924	87204	63366889
Unresponsive to stimuli	31.26	12.70	62	34867	33754	63420339
Drug interaction	30.40	12.70	223	34706	228908	63225185
Hypersensitivity	30.39	12.70	73	34856	292612	63161481
Application site bruise	30.27	12.70	10	34919	320	63453773
Neutropenia	30.21	12.70	31	34898	174974	63279119
Premature baby	29.57	12.70	46	34883	20689	63433404
Injection site abscess	29.45	12.70	14	34915	1184	63452909
Application site papules	28.71	12.70	7	34922	71	63454022
Neurosis	28.15	12.70	9	34920	259	63453834
Injection site ulcer	27.94	12.70	11	34918	587	63453506
Thrombocytopenia	26.98	12.70	26	34903	151131	63302962
Product colour issue	26.93	12.70	11	34918	646	63453447
Memory impairment	26.74	12.70	121	34808	104137	63349956
Sinus arrhythmia	26.70	12.70	14	34915	1459	63452634
Foetal malformation	26.17	12.70	8	34921	198	63453895
Faeces soft	26.00	12.70	23	34906	5669	63448424
Eyelid retraction	25.88	12.70	6	34923	48	63454045
Hypertension	25.68	12.70	74	34855	279229	63174864
Monoplegia	25.61	12.70	18	34911	3183	63450910
Maternal drugs affecting foetus	25.59	12.70	22	34907	5220	63448873
Small for dates baby	25.25	12.70	19	34910	3732	63450361
Endocarditis staphylococcal	24.80	12.70	9	34920	383	63453710
Faecaloma	24.75	12.70	26	34903	7915	63446178
Genitourinary symptom	24.50	12.70	6	34923	62	63454031
Application site perspiration	24.30	12.70	5	34924	21	63454072
Tooth hypoplasia	24.25	12.70	6	34923	65	63454028
Injection site oedema	24.24	12.70	13	34916	1419	63452674
Conjunctival haemorrhage	23.77	12.70	18	34911	3569	63450524
Hepatitis C	23.47	12.70	21	34908	5253	63448840
Delirium	23.39	12.70	71	34858	50470	63403623
Condition aggravated	23.34	12.70	128	34801	402089	63052004
Victim of sexual abuse	23.18	12.70	10	34919	674	63453419
Vulvar basal cell carcinoma	22.82	12.70	5	34924	30	63454063
Asphyxia	22.48	12.70	22	34907	6159	63447934
Maternal use of illicit drugs	22.36	12.70	4	34925	6	63454087
Product contamination	22.17	12.70	10	34919	750	63453343
Dermatitis allergic	22.15	12.70	34	34895	15114	63438979
Pneumonia	22.02	12.70	154	34775	456613	62997480
Irritable bowel syndrome	21.81	12.70	9	34920	82403	63371690
Pre-eclampsia	21.77	12.70	26	34903	9107	63444986
Gastrooesophageal reflux disease	21.61	12.70	107	34822	95532	63358561
Folliculitis	21.52	12.70	6	34923	70311	63383782
Judgement impaired	21.30	12.70	10	34919	822	63453271
Focal segmental glomerulosclerosis	21.19	12.70	12	34917	1456	63452637
Psoriatic arthropathy	21.16	12.70	12	34917	91508	63362585
Somnolence neonatal	21.12	12.70	6	34923	114	63453979
Muscle injury	21.10	12.70	5	34924	65340	63388753
Stillbirth	20.86	12.70	22	34907	6728	63447365
Urinary incontinence	20.85	12.70	51	34878	31963	63422130
Product substitution issue	20.76	12.70	34	34895	15962	63438131
Therapeutic response shortened	20.74	12.70	29	34900	11859	63442234
Accidental poisoning	20.69	12.70	9	34920	619	63453474
Agitation	20.59	12.70	76	34853	59681	63394412
Cerebral vasoconstriction	20.54	12.70	11	34918	1197	63452896
Premature rupture of membranes	20.50	12.70	19	34910	4974	63449119
Extra dose administered	20.16	12.70	21	34908	6329	63447764
Application site infection	19.97	12.70	5	34924	57	63454036
Ill-defined disorder	19.96	12.70	10	34919	81745	63372348
Tremor neonatal	19.88	12.70	6	34923	142	63453951
Disease progression	19.79	12.70	23	34906	122735	63331358
Depressed level of consciousness	19.78	12.70	77	34852	62001	63392092
Pupil constriction procedure	19.52	12.70	3	34926	0	63454093
Blood cholesterol increased	19.45	12.70	14	34915	94018	63360075
Injection site necrosis	19.44	12.70	11	34918	1333	63452760
Pancreatic steatosis	19.40	12.70	10	34919	1006	63453087
Constipation	19.36	12.70	199	34730	224744	63229349
Neonatal aspiration	19.24	12.70	6	34923	159	63453934
Radial nerve palsy	19.18	12.70	8	34921	496	63453597
Impaired healing	19.05	12.70	17	34912	102525	63351568
Therapy non-responder	18.96	12.70	9	34920	75892	63378201
Gastrointestinal hypomotility	18.82	12.70	10	34919	1071	63453022
Product dose omission issue	18.78	12.70	66	34863	234247	63219846
Heart rate abnormal	18.73	12.70	18	34911	4929	63449164
Weight increased	18.62	12.70	77	34852	260715	63193378
Expulsion of medication	18.55	12.70	4	34925	22	63454071
Sedation	18.41	12.70	55	34874	38754	63415339
Enlarged uvula	18.41	12.70	6	34923	184	63453909
Injection site erosion	18.35	12.70	5	34924	81	63454012
Product prescribing error	18.33	12.70	43	34886	26246	63427847
Pancytopenia	18.09	12.70	16	34913	96917	63357176
Dyspnoea	18.01	12.70	256	34673	661057	62793036
Foetal death	18.00	12.70	26	34903	10954	63443139
Substance dependence	17.99	12.70	6	34923	198	63453895
Application site pustules	17.98	12.70	4	34925	26	63454067
Influenza	17.93	12.70	20	34909	108702	63345391
Interstitial lung disease	17.65	12.70	6	34923	61902	63392191
Bruxism	17.63	12.70	15	34914	3510	63450583
Neonatal respiratory distress	17.52	12.70	7	34922	388	63453705
Respiratory acidosis	17.48	12.70	20	34909	6695	63447398
Application site discomfort	17.47	12.70	7	34922	391	63453702
Abdominal pain upper	17.46	12.70	182	34747	206262	63247831
Product quality issue	17.18	12.70	51	34878	35814	63418279
Product odour abnormal	17.12	12.70	10	34919	1286	63452807
Neutrophil count decreased	16.91	12.70	5	34924	56401	63397692
Type 2 diabetes mellitus	16.86	12.70	7	34922	63861	63390232
Premature labour	16.80	12.70	27	34902	12477	63441616
Nausea	16.74	12.70	600	34329	853871	62600222
Bronchitis	16.53	12.70	27	34902	124908	63329185
Cardio-respiratory arrest	16.43	12.70	71	34858	59888	63394205
Persistent depressive disorder	16.29	12.70	9	34920	1041	63453052
Dental discomfort	16.14	12.70	7	34922	478	63453615
Arterial thrombosis	16.13	12.70	10	34919	1433	63452660
Wound	15.93	12.70	42	34887	163221	63290872
Off label use	15.69	12.70	269	34660	674193	62779900
Pharyngitis streptococcal	15.67	12.70	24	34905	10648	63443445
Mental disorder	15.53	12.70	40	34889	25879	63428214
Psoriasis	15.46	12.70	15	34914	86942	63367151
Hypersomnia	15.38	12.70	32	34897	18023	63436070
Application site laceration	15.36	12.70	3	34926	9	63454084
Dyspnoea exertional	15.29	12.70	7	34922	60295	63393798
Feeling of body temperature change	15.20	12.70	16	34913	4881	63449212
Lack of application site rotation	15.12	12.70	3	34926	10	63454083
Anaemia	15.08	12.70	97	34832	293333	63160760
Repetitive strain injury	14.96	12.70	5	34924	166	63453927
Oral mucosal blistering	14.79	12.70	17	34912	5716	63448377
Adjacent segment degeneration	14.70	12.70	3	34926	12	63454081
Product size issue	14.66	12.70	6	34923	354	63453739
Confusional state	14.51	12.70	196	34733	236184	63217909
Product monitoring error	14.46	12.70	15	34914	4501	63449592
Mobility decreased	14.39	12.70	28	34901	121131	63332962
Application site warmth	14.37	12.70	5	34924	188	63453905
Application site paraesthesia	14.34	12.70	4	34925	71	63454022
Lymphocytosis	14.30	12.70	12	34917	2755	63451338
Rash	14.25	12.70	220	34709	560651	62893442
Tooth discolouration	14.21	12.70	8	34921	960	63453133
Labelled drug-drug interaction medication error	14.15	12.70	26	34903	13373	63440720
Glomerular filtration rate	13.99	12.70	3	34926	16	63454077
Ankyloglossia congenital	13.98	12.70	5	34924	204	63453889
Therapeutic response increased	13.94	12.70	6	34923	402	63453691
Serotonin syndrome	13.94	12.70	41	34888	28641	63425452
Cataract	13.89	12.70	7	34922	57046	63397047
Coma	13.82	12.70	71	34858	64293	63389800
Premature separation of placenta	13.82	12.70	10	34919	1851	63452242
Psychomotor skills impaired	13.77	12.70	11	34918	2357	63451736
Drug abuser	13.73	12.70	12	34917	2911	63451182
Femoral neck fracture	13.70	12.70	20	34909	8503	63445590
Cystic lymphangioma	13.69	12.70	3	34926	18	63454075
Viral titre decreased	13.69	12.70	3	34926	18	63454075
Productive cough	13.62	12.70	9	34920	63199	63390894
Bradypnoea	13.60	12.70	13	34916	3537	63450556
COVID-19	13.55	12.70	26	34903	113077	63341016
Reaction to excipient	13.53	12.70	9	34920	1455	63452638
Learning disability	13.47	12.70	5	34924	227	63453866
Restlessness	13.27	12.70	41	34888	29412	63424681
Application site hypersensitivity	13.24	12.70	5	34924	238	63453855
Lack of administration site rotation	13.17	12.70	3	34926	22	63454071
Substance abuser	13.17	12.70	3	34926	22	63454071
Paraesthesia	13.09	12.70	138	34791	156828	63297265
Hip arthroplasty	12.94	12.70	5	34924	47641	63406452
Lip swelling	12.87	12.70	42	34887	31021	63423072
Gastric cyst	12.86	12.70	4	34925	105	63453988
Lividity	12.73	12.70	5	34924	265	63453828
Injection site inflammation	12.73	12.70	13	34916	3830	63450263
Drug dependence, antepartum	12.73	12.70	3	34926	26	63454067
Kleptomania	12.73	12.70	3	34926	26	63454067

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	1799.74	14.74	1133	31969	97963	34825866
Drug withdrawal syndrome	1757.28	14.74	672	32430	19162	34904667
Drug dependence	1120.36	14.74	517	32585	23700	34900129
Intentional product misuse	788.14	14.74	507	32595	45104	34878725
Substance abuse	636.65	14.74	248	32854	7393	34916436
Product adhesion issue	582.79	14.74	159	32943	1441	34922388
Toxicity to various agents	573.08	14.74	818	32284	199544	34724285
Miosis	560.37	14.74	241	32861	9294	34914535
Drug withdrawal syndrome neonatal	548.85	14.74	183	32919	3436	34920393
Injection site pain	450.83	14.74	339	32763	38666	34885163
Application site pruritus	374.71	14.74	110	32992	1327	34922502
Withdrawal syndrome	295.77	14.74	170	32932	12285	34911544
Inadequate analgesia	292.45	14.74	109	32993	2866	34920963
Application site erythema	279.67	14.74	99	33003	2237	34921592
Application site rash	279.01	14.74	78	33024	779	34923050
Drug use disorder	262.90	14.74	111	32991	4080	34919749
Intentional product use issue	262.69	14.74	303	32799	59513	34864316
Overdose	260.77	14.74	373	32729	90686	34833143
Alcohol abuse	241.26	14.74	108	32994	4582	34919247
Coma	230.74	14.74	249	32853	45429	34878400
Foetal exposure during pregnancy	221.62	14.74	224	32878	37877	34885952
Application site burn	206.25	14.74	47	33055	181	34923648
Respiratory depression	202.71	14.74	148	32954	16097	34907732
Myelopathy	200.66	14.74	79	33023	2418	34921411
Injection site infection	184.30	14.74	59	33043	967	34922862
Somnolence	184.10	14.74	356	32746	110760	34813069
Asphyxia	177.63	14.74	99	33003	6736	34917093
Injection site abscess	174.04	14.74	54	33048	795	34923034
Drug screen positive	168.99	14.74	80	33022	3863	34919966
Injection site ulcer	168.68	14.74	41	33061	221	34923608
Application site vesicles	159.46	14.74	47	33055	575	34923254
Drug detoxification	156.64	14.74	39	33063	236	34923593
Drug delivery system removal	149.09	14.74	25	33077	0	34923829
Application site pain	148.53	14.74	59	33043	1849	34921980
Injection site erythema	144.31	14.74	120	32982	15779	34908050
Wrong technique in product usage process	142.44	14.74	173	32929	35813	34888016
Accidental overdose	133.04	14.74	127	32975	20013	34903816
Drug screen negative	130.49	14.74	31	33071	149	34923680
Brain oedema	124.78	14.74	104	32998	13717	34910112
Injection site necrosis	111.64	14.74	33	33069	408	34923421
Accidental poisoning	108.11	14.74	37	33065	753	34923076
Maternal exposure during breast feeding	107.36	14.74	44	33058	1497	34922332
Agitation	106.21	14.74	193	32909	57206	34866623
Injection site erosion	101.25	14.74	23	33079	87	34923742
Application site irritation	100.80	14.74	34	33068	661	34923168
Febrile neutropenia	99.53	14.74	8	33094	136841	34786988
Compartment syndrome	98.86	14.74	51	33051	2967	34920862
Injection site extravasation	97.19	14.74	50	33052	2892	34920937
Euphoric mood	92.94	14.74	61	33041	5580	34918249
Quadriparesis	86.69	14.74	38	33064	1531	34922298
Jaundice neonatal	85.57	14.74	36	33066	1310	34922519
Aggression	79.77	14.74	137	32965	38827	34885002
Diarrhoea	79.51	14.74	156	32946	389756	34534073
Pyrexia	77.10	14.74	123	32979	332890	34590939
Application site reaction	74.53	14.74	24	33078	401	34923428
Bradypnoea	73.56	14.74	41	33061	2788	34921041
Poor feeding infant	72.90	14.74	25	33077	512	34923317
Exposure via breast milk	71.76	14.74	36	33066	1974	34921855
Brachial artery entrapment syndrome	71.56	14.74	12	33090	0	34923829
Drug diversion	71.28	14.74	28	33074	851	34922978
Atrial fibrillation	70.38	14.74	15	33087	122378	34801451
Accidental exposure to product by child	69.60	14.74	32	33070	1444	34922385
Logorrhoea	68.15	14.74	37	33065	2389	34921440
Pulmonary oedema	66.31	14.74	142	32960	47387	34876442
Intentional removal of drug delivery system by patient	65.60	14.74	11	33091	0	34923829
Visceral congestion	65.28	14.74	24	33078	606	34923223
Hyperhidrosis	65.17	14.74	188	32914	75504	34848325
Inappropriate schedule of product administration	64.91	14.74	166	32936	62130	34861699
Drug interaction	64.76	14.74	400	32702	225546	34698283
Depressed level of consciousness	64.43	14.74	132	32970	42709	34881120
Cough	64.15	14.74	31	33071	150109	34773720
Pneumonia	63.26	14.74	158	32944	362469	34561360
Platelet count decreased	62.38	14.74	18	33084	119699	34804130
Injection site vesicles	61.49	14.74	24	33078	717	34923112
Dysarthria	60.58	14.74	114	32988	34668	34889161
Poisoning	60.50	14.74	66	33036	12160	34911669
Cluster headache	60.27	14.74	22	33080	544	34923285
Spinal shock	60.05	14.74	13	33089	37	34923792
Application site dryness	57.51	14.74	14	33088	76	34923753
Injection site discharge	57.30	14.74	17	33085	213	34923616
Congenital multiplex arthrogryposis	56.45	14.74	13	33089	53	34923776
Injection site cellulitis	56.04	14.74	21	33081	560	34923269
Death	55.68	14.74	598	32504	397451	34526378
Application site urticaria	54.29	14.74	13	33089	65	34923764
Prescription drug used without a prescription	52.70	14.74	30	33072	2124	34921705
Premature baby	52.50	14.74	78	33024	19555	34904274
Deafness neurosensory	52.11	14.74	33	33069	2838	34920991
Tremor neonatal	51.80	14.74	18	33084	384	34923445
White blood cell count decreased	50.36	14.74	14	33088	95431	34828398
Hepatitis C	50.27	14.74	54	33048	9776	34914053
Neutropenia	49.91	14.74	45	33057	156733	34767096
Rhabdomyolysis	49.02	14.74	159	32943	68004	34855825
Dermo-hypodermitis	48.97	14.74	18	33084	454	34923375
Drug abuser	46.99	14.74	35	33067	3919	34919910
Low birth weight baby	46.86	14.74	47	33055	7858	34915971
Disease progression	46.62	14.74	22	33080	108055	34815774
Cardiac failure congestive	46.26	14.74	11	33091	83259	34840570
Injection site warmth	45.88	14.74	27	33075	2035	34921794
Application site swelling	45.80	14.74	15	33087	265	34923564
Therapeutic product effect increased	45.09	14.74	19	33083	694	34923135
Impaired driving ability	44.66	14.74	29	33073	2604	34921225
Dyspnoea	44.38	14.74	195	32907	376587	34547242
Product solubility abnormal	43.74	14.74	17	33085	502	34923327
Product dose omission issue	43.58	14.74	30	33072	119681	34804148
Haemoglobin decreased	43.00	14.74	31	33071	120741	34803088
Sarcopenia	42.65	14.74	16	33086	428	34923401
Endocarditis staphylococcal	42.58	14.74	16	33086	430	34923399
Hallucination	42.46	14.74	126	32976	51372	34872457
COVID-19	41.61	14.74	11	33091	77539	34846290
Disorientation	41.58	14.74	95	33007	33093	34890736
Product dispensing issue	41.12	14.74	10	33092	54	34923775
Arthralgia	40.96	14.74	61	33041	169980	34753849
Neuropathy peripheral	40.71	14.74	14	33088	83249	34840580
Application site discolouration	40.67	14.74	14	33088	290	34923539
Oral administration complication	40.52	14.74	10	33092	58	34923771
Substance use disorder	40.25	14.74	18	33084	761	34923068
Breech presentation	40.18	14.74	12	33090	154	34923675
Application site exfoliation	40.18	14.74	12	33090	154	34923675
Injection site irritation	40.07	14.74	21	33081	1262	34922567
Restlessness	40.06	14.74	80	33022	25402	34898427
Fatigue	39.99	14.74	198	32904	370455	34553374
Intentional underdose	39.59	14.74	17	33085	651	34923178
Product administered at inappropriate site	38.84	14.74	25	33077	2211	34921618
Asthenia	38.78	14.74	112	32990	245139	34678690
Skin irritation	38.39	14.74	36	33066	5541	34918288
Application site hypersensitivity	38.30	14.74	11	33091	122	34923707
Application site scar	37.99	14.74	8	33094	19	34923810
Foetal distress syndrome	37.22	14.74	19	33083	1081	34922748
Aptyalism	36.92	14.74	14	33088	386	34923443
Hypotension	36.68	14.74	99	33003	221550	34702279
Application site discharge	36.36	14.74	11	33091	148	34923681
Housebound	35.93	14.74	12	33090	226	34923603
Application site erosion	35.75	14.74	10	33092	100	34923729
Substance use	35.74	14.74	16	33086	678	34923151
Anxiety	35.60	14.74	187	32915	99241	34824588
Injection site swelling	35.52	14.74	49	33053	11478	34912351
Endocarditis	35.48	14.74	37	33065	6474	34917355
Decreased gait velocity	35.32	14.74	11	33091	164	34923665
Acute kidney injury	35.16	14.74	159	32943	304829	34619000
Congestive hepatopathy	35.09	14.74	22	33080	1859	34921970
Injection site pruritus	35.08	14.74	38	33064	6945	34916884
Prescription form tampering	34.84	14.74	14	33088	452	34923377
Therapeutic product effect decreased	34.53	14.74	91	33011	34652	34889177
Product packaging quantity issue	34.23	14.74	17	33085	912	34922917
Infusion related reaction	33.74	14.74	5	33097	53052	34870777
Interstitial lung disease	33.64	14.74	10	33092	65272	34858557
Incorrect route of product administration	32.76	14.74	54	33048	14791	34909038
Anaemia	32.36	14.74	113	32989	233222	34690607
Phlebotomy	32.17	14.74	9	33093	90	34923739
Malignant neoplasm progression	32.12	14.74	22	33080	88024	34835805
Off label use	31.81	14.74	250	32852	419274	34504555
Pleural effusion	31.63	14.74	19	33083	81527	34842302
Respiratory arrest	31.57	14.74	77	33025	27966	34895863
Wrong dose	31.46	14.74	14	33088	585	34923244
Bradyphrenia	31.18	14.74	30	33072	4768	34919061
Hyponatraemia	31.06	14.74	20	33082	82671	34841158
Persecutory delusion	31.02	14.74	23	33079	2557	34921272
Thrombocytopenia	30.43	14.74	64	33038	156183	34767646
Road traffic accident	30.13	14.74	57	33045	17393	34906436
Epistaxis	29.88	14.74	9	33093	58242	34865587
Suicidal ideation	29.73	14.74	95	33007	40293	34883536
Sedation	29.55	14.74	63	33039	20943	34902886
Rash	29.47	14.74	110	32992	222642	34701187
Glomerulonephritis acute	28.66	14.74	9	33093	138	34923691
Cerebrovascular accident	28.60	14.74	23	33079	84788	34839041
Injection site inflammation	28.59	14.74	15	33087	903	34922926
Vestibular ischaemia	28.57	14.74	6	33096	14	34923815
Blood creatinine increased	28.17	14.74	29	33073	94947	34828882
Blood glucose increased	28.12	14.74	14	33088	66704	34857125
Feeding intolerance	28.02	14.74	9	33093	149	34923680
Aspartate aminotransferase increased	27.42	14.74	15	33087	67768	34856061
Thrombosis	27.36	14.74	7	33095	50451	34873378
Substance dependence	26.90	14.74	11	33091	372	34923457
Ear deformity acquired	26.36	14.74	5	33097	5	34923824
Haemorrhage	26.23	14.74	8	33094	51362	34872467
Agitation neonatal	26.10	14.74	15	33087	1081	34922748
Injection site bruising	25.46	14.74	36	33066	8627	34915202
Application site scab	25.21	14.74	7	33095	68	34923761
Dehydration	24.66	14.74	54	33048	129915	34793914
Treatment failure	24.34	14.74	7	33095	46690	34877139
Product use issue	24.07	14.74	121	32981	63095	34860734
Respiratory rate decreased	23.91	14.74	19	33083	2340	34921489
Coronary artery disease	23.82	14.74	8	33094	48297	34875532
Altered state of consciousness	23.81	14.74	61	33041	22832	34900997
Mastication disorder	23.39	14.74	15	33087	1318	34922511
Vestibular disorder	23.34	14.74	14	33088	1093	34922736
Myocardial infarction	23.23	14.74	50	33052	121035	34802794
Hyperkalaemia	23.17	14.74	19	33083	69370	34854459
Joint swelling	23.16	14.74	14	33088	59876	34863953
Rhesus incompatibility	23.10	14.74	6	33096	44	34923785
Dependence	22.85	14.74	14	33088	1136	34922693
Back pain	22.78	14.74	51	33051	121738	34802091
Prostate cancer	22.48	14.74	5	33097	39644	34884185
Herpes zoster	22.43	14.74	3	33099	34396	34889433
Expulsion of medication	22.32	14.74	6	33096	51	34923778
Clumsiness	22.09	14.74	16	33086	1716	34922113
Pneumonia aspiration	21.81	14.74	88	33014	41815	34882014
Electrocardiogram T wave alternans	21.79	14.74	5	33097	20	34923809
Application site haemorrhage	21.61	14.74	10	33092	458	34923371
Paranoia	21.55	14.74	40	33062	12028	34911801
Hypoventilation	21.53	14.74	21	33081	3393	34920436
International normalised ratio increased	21.39	14.74	9	33093	47318	34876511
Hallucination, visual	21.26	14.74	50	33052	17741	34906088
Joint hyperextension	21.10	14.74	7	33095	129	34923700
Diabetes mellitus	21.04	14.74	9	33093	46864	34876965
Delirium	21.02	14.74	90	33012	43901	34879928
Chronic actinic dermatitis	20.88	14.74	5	33097	25	34923804
Behavioural addiction	20.77	14.74	6	33096	68	34923761
Product physical issue	20.63	14.74	18	33084	2523	34921306
Neonatal aspiration	20.38	14.74	6	33096	73	34923756
Weight increased	19.92	14.74	36	33066	92997	34830832
Hypoxic-ischaemic encephalopathy	19.91	14.74	23	33079	4509	34919320
Coordination abnormal	19.90	14.74	30	33072	7614	34916215
Troponin T increased	19.66	14.74	17	33085	2354	34921475
Blood bilirubin increased	19.48	14.74	6	33096	38290	34885539
Pancytopenia	19.34	14.74	38	33064	95119	34828710
Poisoning deliberate	19.32	14.74	30	33072	7814	34916015
Accidental death	19.15	14.74	17	33085	2439	34921390
Intentional overdose	19.09	14.74	87	33015	43587	34880242
Pulmonary congestion	19.03	14.74	41	33061	13724	34910105
Bronchitis	18.93	14.74	8	33094	41955	34881874
Renal failure	18.90	14.74	62	33040	130495	34793334
Adrenergic syndrome	18.87	14.74	6	33096	96	34923733
Injection site induration	18.81	14.74	18	33084	2842	34920987
Therapy naive	18.76	14.74	5	33097	41	34923788
Micrognathia	18.64	14.74	8	33094	306	34923523
Alcohol interaction	18.53	14.74	18	33084	2895	34920934
Abdominal distension	18.33	14.74	17	33085	58475	34865354
Neutrophil count decreased	18.32	14.74	13	33089	51091	34872738
Product use in unapproved indication	18.28	14.74	54	33048	117445	34806384
Laryngomalacia	18.21	14.74	8	33094	324	34923505
Psoriasis	18.16	14.74	7	33095	38805	34885024
Application site odour	17.89	14.74	3	33099	0	34923829
Injection site ischaemia	17.89	14.74	3	33099	0	34923829
Infection	17.88	14.74	37	33065	90878	34832951
Sepsis	17.87	14.74	89	33013	166472	34757357
Intentional misuse of drug delivery system	17.85	14.74	4	33098	14	34923815
Unresponsive to stimuli	17.75	14.74	62	33040	27507	34896322
Hypertonia	17.74	14.74	21	33081	4225	34919604
Hypertension	17.61	14.74	68	33034	136375	34787454
Dementia with Lewy bodies	17.60	14.74	10	33092	705	34923124
Respiratory failure	17.54	14.74	49	33053	108523	34815306
Product contamination	17.51	14.74	10	33092	712	34923117
Brief psychotic disorder with marked stressors	17.48	14.74	7	33095	224	34923605
Product substitution issue	17.45	14.74	33	33069	10062	34913767
Gastrointestinal haemorrhage	17.41	14.74	36	33066	88441	34835388
Renal impairment	17.32	14.74	40	33062	94473	34829356
Embolia cutis medicamentosa	17.25	14.74	7	33095	232	34923597
Victim of crime	17.11	14.74	8	33094	375	34923454
Hyperglycaemia	17.06	14.74	8	33094	39472	34884357
Application site ulcer	16.87	14.74	4	33098	19	34923810
Multiple cardiac defects	16.75	14.74	5	33097	64	34923765
Psychotic disorder	16.63	14.74	56	33046	24396	34899433
Anaphylactic reaction	16.54	14.74	5	33097	32296	34891533
Emotional poverty	16.46	14.74	9	33093	589	34923240
Disturbance in attention	16.41	14.74	58	33044	25887	34897942
Abdominal pain	16.11	14.74	90	33012	163528	34760301
Mental status changes	16.03	14.74	8	33094	38075	34885754
Deafness bilateral	15.85	14.74	11	33091	1103	34922726
Administration site abscess sterile	15.81	14.74	3	33099	3	34923826
Dermal absorption impaired	15.81	14.74	3	33099	3	34923826
Gun shot wound	15.72	14.74	11	33091	1117	34922712
Delusion	15.63	14.74	36	33066	12599	34911230
Dyspnoea exertional	15.53	14.74	11	33091	43268	34880561
Cataract	15.47	14.74	3	33099	26183	34897646
Drug reaction with eosinophilia and systemic symptoms	15.37	14.74	6	33096	33006	34890823
Incoherent	15.36	14.74	20	33082	4432	34919397
Rash maculo-papular	15.32	14.74	4	33098	28447	34895382
Selective eating disorder	15.26	14.74	13	33089	1765	34922064
Alcohol withdrawal syndrome	15.13	14.74	12	33090	1474	34922355
Injection site discolouration	15.08	14.74	12	33090	1481	34922348
Decreased appetite	15.07	14.74	94	33008	166298	34757531
Eschar	15.00	14.74	9	33093	703	34923126
Rectal haemorrhage	14.75	14.74	10	33092	40239	34883590

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug abuse	2105.40	11.99	1303	49836	161388	79531861
Drug withdrawal syndrome	1627.02	11.99	667	50472	34051	79659198
Drug dependence	1175.73	11.99	557	50582	40212	79653037
Application site pruritus	1122.40	11.99	295	50844	3515	79689734
Product adhesion issue	990.12	11.99	249	50890	2455	79690794
Application site erythema	820.18	11.99	246	50893	4864	79688385
Toxicity to various agents	735.15	11.99	1110	50029	420430	79272819
Intentional product misuse	724.81	11.99	551	50588	94614	79598635
Substance abuse	671.17	11.99	253	50886	10273	79682976
Miosis	610.91	11.99	265	50874	15524	79677725
Application site rash	598.83	11.99	159	50980	1973	79691276
Application site pain	477.20	11.99	160	50979	4587	79688662
Application site burn	476.58	11.99	111	51028	764	79692485
Inadequate analgesia	473.18	11.99	158	50981	4471	79688778
Application site vesicles	445.71	11.99	116	51023	1324	79691925
Withdrawal syndrome	350.44	11.99	217	50922	26637	79666612
Respiratory depression	342.25	11.99	216	50923	27414	79665835
Overdose	339.53	11.99	499	50640	183707	79509542
Drug use disorder	301.62	11.99	135	51004	8516	79684733
Accidental overdose	298.31	11.99	228	50911	39353	79653896
Alcohol abuse	295.69	11.99	116	51023	5247	79688002
Coma	257.49	11.99	320	50819	100329	79592920
Somnolence	250.46	11.99	504	50635	238477	79454772
Asphyxia	200.90	11.99	113	51026	11607	79681642
Application site irritation	200.22	11.99	65	51074	1679	79691570
Application site scar	178.98	11.99	38	51101	159	79693090
Intentional product use issue	164.19	11.99	325	50814	151787	79541462
Application site dryness	159.95	11.99	36	51103	208	79693041
Accidental exposure to product by child	153.28	11.99	61	51078	2865	79690384
Drug interaction	151.58	11.99	596	50543	414587	79278662
Drug screen positive	139.17	11.99	71	51068	5992	79687257
Death	137.75	11.99	721	50418	565793	79127456
Application site discolouration	136.04	11.99	41	51098	823	79692426
Wrong technique in product usage process	134.21	11.99	199	50940	73676	79619573
Agitation	133.79	11.99	234	50905	99481	79593768
Application site discharge	131.09	11.99	33	51106	326	79692923
Accidental poisoning	124.65	11.99	45	51094	1612	79691637
Injection site ulcer	121.35	11.99	36	51103	683	79692566
Application site exfoliation	117.98	11.99	33	51106	503	79692746
Injection site abscess	117.63	11.99	43	51096	1597	79691652
Application site urticaria	116.95	11.99	28	51111	220	79693029
Drug detoxification	112.90	11.99	30	51109	373	79692876
Brain oedema	105.65	11.99	104	51035	25159	79668090
Application site erosion	103.00	11.99	26	51113	260	79692989
Drug delivery system removal	101.65	11.99	16	51123	0	79693249
Aggression	100.88	11.99	143	50996	50815	79642434
Injection site pain	97.58	11.99	240	50899	129598	79563651
Depressed level of consciousness	94.13	11.99	198	50941	96454	79596795
Blepharospasm	93.78	11.99	54	51085	5797	79687452
Injection site infection	91.68	11.99	39	51100	2173	79691076
Febrile neutropenia	90.28	11.99	19	51120	230980	79462269
Hyperhidrosis	87.51	11.99	254	50885	151238	79542011
Hyperaesthesia	86.79	11.99	68	51071	12154	79681095
Bradypnoea	84.26	11.99	51	51088	6001	79687248
Euphoric mood	82.37	11.99	55	51084	7671	79685578
Pyrexia	81.85	11.99	198	50941	678511	79014738
Taste disorder	79.27	11.99	72	51067	15751	79677498
Infusion related reaction	78.40	11.99	25	51114	230212	79463037
Diarrhoea	77.54	11.99	297	50842	880192	78813057
Logorrhoea	77.29	11.99	43	51096	4322	79688927
Drug screen negative	76.93	11.99	21	51118	291	79692958
Hepatitis C	75.43	11.99	62	51077	11863	79681386
Endocarditis staphylococcal	74.72	11.99	25	51114	711	79692538
Application site swelling	74.16	11.99	25	51114	728	79692521
Hallucination	73.63	11.99	167	50972	85578	79607671
Skin irritation	72.27	11.99	59	51080	11181	79682068
Arthropathy	70.37	11.99	14	51125	177097	79516152
Application site reaction	69.53	11.99	24	51115	752	79692497
Drug diversion	68.77	11.99	27	51112	1223	79692026
Pulmonary oedema	68.26	11.99	165	50974	88089	79605160
Product physical issue	68.07	11.99	39	51100	4146	79689103
Injection site necrosis	67.76	11.99	28	51111	1450	79691799
Maternal exposure during pregnancy	67.67	11.99	217	50922	136321	79556928
Poisoning	67.20	11.99	82	51057	25190	79668059
Disturbance in attention	65.24	11.99	117	51022	50684	79642565
Inappropriate schedule of product administration	64.98	11.99	211	50928	133417	79559832
Application site scab	64.53	11.99	17	51122	204	79693045
Synovitis	64.05	11.99	10	51129	150724	79542525
Drug withdrawal syndrome neonatal	63.71	11.99	18	51121	285	79692964
Joint swelling	63.52	11.99	55	51084	288591	79404658
Respiratory arrest	62.05	11.99	123	51016	57427	79635822
Product administered at inappropriate site	61.96	11.99	36	51103	3929	79689320
Suicidal ideation	60.41	11.99	144	50995	76196	79617053
Brachial artery entrapment syndrome	59.34	11.99	13	51126	65	79693184
Arthralgia	58.24	11.99	181	50958	571622	79121627
Disorientation	58.09	11.99	126	51013	62650	79630599
Intentional removal of drug delivery system by patient	57.18	11.99	9	51130	0	79693249
Treatment failure	57.16	11.99	19	51120	170467	79522782
Cough	57.06	11.99	92	51047	366697	79326552
Product solubility abnormal	57.03	11.99	22	51117	950	79692299
Platelet count decreased	56.59	11.99	27	51112	194637	79498612
Injection site erosion	56.59	11.99	14	51125	128	79693121
Cluster headache	56.51	11.99	22	51117	974	79692275
Stress cardiomyopathy	56.30	11.99	51	51088	11115	79682134
Compartment syndrome	56.16	11.99	37	51102	5045	79688204
Application site haemorrhage	55.88	11.99	24	51115	1369	79691880
Fatigue	55.66	11.99	359	50780	929368	78763881
Intentional underdose	55.29	11.99	28	51111	2326	79690923
White blood cell count decreased	53.39	11.99	27	51112	188261	79504988
Drug abuser	52.81	11.99	38	51101	5975	79687274
Application site ulcer	52.63	11.99	13	51126	118	79693131
Sinusitis	52.56	11.99	30	51109	195471	79497778
Neutropenia	50.79	11.99	66	51073	287644	79405605
Substance dependence	50.69	11.99	17	51122	487	79692762
Restlessness	49.67	11.99	99	51040	46393	79646856
Dysarthria	48.66	11.99	123	51016	67499	79625750
Unresponsive to stimuli	48.26	11.99	109	51030	55679	79637570
Sarcopenia	47.82	11.99	16	51123	455	79692794
Application site dermatitis	47.57	11.99	13	51126	181	79693068
Systemic lupus erythematosus	47.23	11.99	10	51129	121139	79572110
Myelopathy	47.04	11.99	32	51107	4601	79688648
Therapeutic product effect increased	46.85	11.99	22	51117	1549	79691700
Haemoglobin decreased	46.85	11.99	44	51095	222075	79471174
Pericarditis	46.42	11.99	6	51133	104230	79589019
Hand deformity	46.23	11.99	6	51133	103913	79589336
Pemphigus	46.16	11.99	5	51134	99577	79593672
Delirium	46.07	11.99	139	51000	84488	79608761
Infection	45.23	11.99	53	51086	241659	79451590
Defaecation disorder	45.21	11.99	17	51122	684	79692565
Application site odour	44.97	11.99	9	51130	26	79693223
Quadriparesis	44.91	11.99	28	51111	3473	79689776
Injection site extravasation	44.56	11.99	42	51097	9627	79683622
Substance use disorder	43.78	11.99	18	51121	920	79692329
Yawning	43.44	11.99	20	51119	1346	79691903
Dermo-hypodermitis	43.28	11.99	17	51122	771	79692478
Rheumatoid arthritis	43.14	11.99	42	51097	208428	79484821
Confusional state	42.12	11.99	348	50791	317649	79375600
Endocarditis	41.31	11.99	42	51097	10555	79682694
Epilepsy	41.26	11.99	85	51054	40775	79652474
Product dose omission issue	40.46	11.99	60	51079	247477	79445772
Breakthrough pain	40.43	11.99	19	51120	1340	79691909
Visceral congestion	40.10	11.99	17	51122	939	79692310
Swelling	40.03	11.99	48	51091	216663	79476586
Application site inflammation	39.92	11.99	14	51125	460	79692789
Pneumonia	39.90	11.99	254	50885	659992	79033257
Impaired reasoning	39.61	11.99	10	51129	100	79693149
Congenital coronary artery malformation	39.09	11.99	10	51129	106	79693143
Decreased gait velocity	38.71	11.99	11	51128	178	79693071
Interstitial lung disease	38.71	11.99	12	51127	112588	79580661
Subchondral insufficiency fracture	38.63	11.99	9	51130	62	79693187
17 ketosteroids urine abnormal	38.12	11.99	6	51133	0	79693249
Alopecia	37.89	11.99	56	51083	231299	79461950
Bradycardia foetal	37.66	11.99	10	51129	124	79693125
Disease progression	37.16	11.99	38	51101	184324	79508925
Hypertension	37.12	11.99	100	51039	330892	79362357
Pneumonia aspiration	36.45	11.99	110	51029	66857	79626392
Altered state of consciousness	36.11	11.99	84	51055	43738	79649511
Impaired driving ability	36.03	11.99	29	51110	5386	79687863
COVID-19	35.95	11.99	29	51110	157645	79535604
Congenital multiplex arthrogryposis	35.86	11.99	7	51132	17	79693232
Deafness neurosensory	35.75	11.99	32	51107	6866	79686383
Rash	35.69	11.99	221	50918	578137	79115112
Incorrect route of product administration	35.67	11.99	73	51066	34856	79658393
Gastrointestinal disorder	35.43	11.99	17	51122	122188	79571061
Phlebotomy	35.04	11.99	9	51130	97	79693152
Thrombocytopenia	34.60	11.99	74	51065	265185	79428064
Product physical consistency issue	34.37	11.99	15	51124	890	79692359
Anti-cyclic citrullinated peptide antibody positive	34.23	11.99	6	51133	83137	79610112
Bradyphrenia	34.09	11.99	38	51101	10602	79682647
Substance use	33.91	11.99	15	51124	919	79692330
Injection site cellulitis	33.79	11.99	18	51121	1660	79691589
Herpes zoster	33.69	11.99	9	51130	93074	79600175
Dyspnoea	33.51	11.99	370	50769	856655	78836594
Aptyalism	33.41	11.99	14	51125	751	79692498
Paranoia	33.34	11.99	51	51088	19381	79673868
Application site pustules	32.83	11.99	7	51132	30	79693219
Injection site discharge	32.44	11.99	14	51125	808	79692441
Contraindicated product administered	32.29	11.99	32	51107	157506	79535743
Mucosal inflammation	32.13	11.99	5	51134	75575	79617674
Off label use	31.88	11.99	401	50738	906814	78786435
Product substitution issue	31.75	11.99	51	51088	20205	79673044
Weight increased	31.70	11.99	83	51056	277303	79415946
Hypersensitivity	31.10	11.99	77	51062	262162	79431087
Loss of consciousness	30.96	11.99	199	50940	167744	79525505
Vestibular ischaemia	30.90	11.99	6	51133	14	79693235
Dermatitis contact	29.65	11.99	36	51103	10997	79682252
Exposure during pregnancy	29.61	11.99	136	51003	100996	79592253
Hallucination, visual	29.48	11.99	65	51074	32664	79660585
Echocardiogram abnormal	29.04	11.99	18	51121	2210	79691039
Musculoskeletal stiffness	29.00	11.99	42	51097	174966	79518283
Poisoning deliberate	28.96	11.99	47	51092	18781	79674468
Hypertonia	28.80	11.99	29	51110	7203	79686046
Housebound	28.74	11.99	11	51128	465	79692784
Application site hypersensitivity	28.65	11.99	10	51129	324	79692925
Ear deformity acquired	28.30	11.99	5	51134	5	79693244
Glossodynia	27.56	11.99	16	51123	103321	79589928
Nasopharyngitis	27.48	11.99	78	51061	253803	79439446
Aspartate aminotransferase increased	27.46	11.99	29	51110	138612	79554637
Abnormal behaviour	26.98	11.99	67	51072	36354	79656895
Pulmonary congestion	26.92	11.99	56	51083	27044	79666205
Psychomotor skills impaired	26.56	11.99	24	51115	5213	79688036
Hepatic enzyme increased	26.34	11.99	48	51091	182562	79510687
Sedation	26.16	11.99	83	51056	51812	79641437
Neurosis	26.03	11.99	10	51129	427	79692822
Persecutory delusion	25.89	11.99	23	51116	4886	79688363
Glomerulonephritis acute	25.89	11.99	9	51130	288	79692961
Product packaging quantity issue	25.84	11.99	14	51125	1335	79691914
Congestive hepatopathy	25.38	11.99	22	51117	4525	79688724
Eyelid retraction	25.31	11.99	6	51133	45	79693204
Blood glucose increased	25.15	11.99	22	51117	114953	79578296
Bronchitis	25.12	11.99	28	51111	130616	79562633
Sinus arrhythmia	24.88	11.99	16	51123	2094	79691155
Product dispensing issue	24.77	11.99	8	51131	203	79693046
Helicobacter infection	24.74	11.99	7	51132	69697	79623552
Duodenal ulcer perforation	24.73	11.99	6	51133	66205	79627044
Feeling drunk	24.67	11.99	22	51117	4697	79688552
Respiratory acidosis	24.51	11.99	33	51106	11167	79682082
Accidental death	24.43	11.99	21	51118	4270	79688979
Neutrophil count decreased	24.42	11.99	15	51124	93944	79599305
Micrognathia	24.37	11.99	5	51134	17	79693232
Neuropathy peripheral	24.32	11.99	33	51106	141272	79551977
Vomiting	24.24	11.99	578	50561	665250	79027999
Alcohol interaction	24.06	11.99	22	51117	4852	79688397
Faecaloma	23.69	11.99	33	51106	11531	79681718
Influenza	23.61	11.99	29	51110	129577	79563672
Atrial fibrillation	23.54	11.99	58	51081	197828	79495421
Chronic actinic dermatitis	23.53	11.99	5	51134	21	79693228
Anxiety	23.38	11.99	253	50886	248259	79444990
Application site induration	23.17	11.99	4	51135	3	79693246
Injection site oedema	22.90	11.99	13	51126	1358	79691891
Wrong dose	22.88	11.99	14	51125	1680	79691569
Asthenia	22.79	11.99	214	50925	511475	79181774
Cardiac failure congestive	22.79	11.99	35	51104	142367	79550882
Application site papules	22.77	11.99	6	51133	72	79693177
Tachyphrenia	22.64	11.99	15	51124	2065	79691184
Pain in extremity	22.08	11.99	140	50999	364398	79328851
Anaemia	22.07	11.99	181	50958	444834	79248415
Vulvar basal cell carcinoma	22.05	11.99	5	51134	30	79693219
Injection site erythema	22.04	11.99	104	51035	78093	79615156
Maternal use of illicit drugs	21.75	11.99	4	51135	6	79693243
Nasal congestion	21.65	11.99	11	51128	76541	79616708
Premature delivery	21.58	11.99	47	51092	23420	79669829
Cerebrovascular accident	21.36	11.99	42	51097	155250	79537999
Prescription drug used without a prescription	21.27	11.99	19	51120	4066	79689183
Mastication disorder	21.24	11.99	16	51123	2697	79690552
Blood cholesterol increased	20.89	11.99	14	51125	83706	79609543
Victim of sexual abuse	20.80	11.99	9	51130	523	79692726
Coronary artery disease	20.74	11.99	8	51131	65466	79627783
Haematocrit decreased	20.25	11.99	7	51132	61305	79631944
Hypoventilation	20.11	11.99	24	51115	7200	79686049
Psoriasis	19.77	11.99	17	51122	89570	79603679
Injection site inflammation	19.73	11.99	18	51121	3958	79689291
Memory impairment	19.73	11.99	131	51008	111603	79581646
Dementia with Lewy bodies	19.68	11.99	10	51129	836	79692413
Expulsion of medication	19.63	11.99	5	51134	52	79693197
Troponin T increased	19.58	11.99	17	51122	3505	79689744
Rhabdomyolysis	19.49	11.99	123	51016	103008	79590241
Malignant neoplasm progression	19.38	11.99	36	51103	135954	79557295
Pancytopenia	19.38	11.99	49	51090	165696	79527553
Cyanosis	19.37	11.99	47	51092	25135	79668114
Upper respiratory tract infection	19.28	11.99	18	51121	91150	79602099
Emotional poverty	19.24	11.99	10	51129	877	79692372
Urticaria	19.23	11.99	58	51081	185143	79508106
Application site bruise	19.20	11.99	7	51132	258	79692991
Tachycardia	19.11	11.99	186	50953	177582	79515667
Oral administration complication	19.10	11.99	6	51133	139	79693110
Foetal non-stress test abnormal	19.06	11.99	3	51136	0	79693249
Pupil constriction procedure	19.06	11.99	3	51136	0	79693249
Drug hypersensitivity	19.03	11.99	113	51026	298803	79394446
Respiratory rate decreased	19.03	11.99	20	51119	5223	79688026
Persistent depressive disorder	18.99	11.99	11	51128	1194	79692055
Suicide attempt	18.96	11.99	104	51035	82828	79610421
Muscle injury	18.94	11.99	4	51135	48557	79644692
Dysphoria	18.88	11.99	19	51120	4715	79688534
Folliculitis	18.85	11.99	6	51133	55374	79637875
Venous thrombosis	18.77	11.99	23	51116	7093	79686156
Adrenergic syndrome	18.70	11.99	6	51133	149	79693100
Substance abuser	18.70	11.99	6	51133	149	79693100
Dyspnoea exertional	18.64	11.99	17	51122	87056	79606193
Therapy non-responder	18.62	11.99	19	51120	92286	79600963
Reaction to excipient	18.61	11.99	12	51127	1577	79691672
Abdominal discomfort	18.61	11.99	90	51049	250637	79442612
Electrocardiogram T wave alternans	18.54	11.99	5	51134	66	79693183
Cardio-respiratory arrest	18.43	11.99	126	51013	108384	79584865
Injection site ischaemia	18.43	11.99	4	51135	19	79693230
Therapy naive	18.40	11.99	5	51134	68	79693181
Diabetes mellitus	18.39	11.99	14	51125	78376	79614873
Radial nerve palsy	18.29	11.99	8	51131	477	79692772
Serotonin syndrome	18.28	11.99	67	51072	44960	79648289
Application site perspiration	18.26	11.99	4	51135	20	79693229
Stomatitis	18.25	11.99	42	51097	146715	79546534
Psoriatic arthropathy	18.21	11.99	14	51125	77985	79615264
Vestibular disorder	18.17	11.99	14	51125	2441	79690808
Mydriasis	18.16	11.99	37	51102	17606	79675643
Brief psychotic disorder with marked stressors	18.15	11.99	7	51132	302	79692947
Haemorrhage	18.10	11.99	19	51120	91099	79602150
Type 2 diabetes mellitus	18.06	11.99	7	51132	57115	79636134
Constipation	18.01	11.99	268	50871	282782	79410467
Delusion	17.76	11.99	40	51099	20383	79672866
Clostridium difficile infection	17.75	11.99	3	51136	42682	79650567
Pleural effusion	17.72	11.99	42	51097	145220	79548029
Irritable bowel syndrome	17.52	11.99	9	51130	62232	79631017
Cataract	17.46	11.99	9	51130	62111	79631138
Foetal exposure during pregnancy	17.39	11.99	20	51119	5770	79687479
Product preparation error	17.39	11.99	20	51119	5773	79687476
Incoherent	17.35	11.99	23	51116	7669	79685580
Application site infection	17.05	11.99	5	51134	91	79693158
Administration site abscess sterile	16.98	11.99	3	51136	3	79693246
Cerebral vasoconstriction	16.97	11.99	11	51128	1459	79691790
Cryoglobulinaemia	16.95	11.99	9	51130	824	79692425
Pancreatic steatosis	16.85	11.99	10	51129	1135	79692114
Intervertebral discitis	16.78	11.99	18	51121	4810	79688439
Throat irritation	16.76	11.99	3	51136	40943	79652306
Tooth hypoplasia	16.72	11.99	6	51133	211	79693038
Adverse drug reaction	16.70	11.99	11	51128	66381	79626868
Haematemesis	16.59	11.99	72	51067	52192	79641057
Abortion spontaneous	16.55	11.99	49	51090	29458	79663791
Apnoea	16.37	11.99	28	51111	11676	79681573
Epistaxis	16.36	11.99	29	51110	111486	79581763
Hyponatraemia	16.19	11.99	59	51080	177789	79515460
Myocardial infarction	16.17	11.99	62	51077	184067	79509182
Chronic hepatitis C	16.02	11.99	8	51131	645	79692604
Knee arthroplasty	15.99	11.99	4	51135	43244	79650005
Faeces soft	15.94	11.99	23	51116	8300	79684949
Allodynia	15.83	11.99	11	51128	1637	79691612
Blood creatinine increased	15.78	11.99	49	51090	155008	79538241
Bruxism	15.77	11.99	16	51123	4010	79689239
Drug reaction with eosinophilia and systemic symptoms	15.68	11.99	11	51128	64233	79629016
Judgement impaired	15.68	11.99	10	51129	1290	79691959
Weight decreased	15.60	11.99	149	50990	355049	79338200
Sepsis	15.53	11.99	105	51034	269323	79423926
Genitourinary symptom	15.47	11.99	6	51133	263	79692986
Product odour abnormal	15.38	11.99	10	51129	1334	79691915
Victim of crime	15.07	11.99	7	51132	481	79692768
Urinary incontinence	15.06	11.99	59	51080	40850	79652399
Heart rate abnormal	15.05	11.99	19	51120	6038	79687211
Cystic lymphangioma	14.91	11.99	3	51136	9	79693240
Productive cough	14.82	11.99	21	51118	88310	79604939
Lactic acidosis	14.75	11.99	14	51125	70345	79622904
Basal cell carcinoma	14.74	11.99	3	51136	37372	79655877
Ascites	14.74	11.99	16	51123	75546	79617703
Injection site irritation	14.73	11.99	15	51124	3775	79689474
Oropharyngeal pain	14.67	11.99	30	51109	109323	79583926
Repetitive strain injury	14.63	11.99	5	51134	152	79693097
Hallucinations, mixed	14.60	11.99	20	51119	6879	79686370
Condition aggravated	14.51	11.99	230	50909	500894	79192355
Migraine	14.50	11.99	101	51038	87392	79605857
Chest discomfort	14.50	11.99	43	51096	138001	79555248
Adjacent segment degeneration	14.24	11.99	3	51136	12	79693237
Ankyloglossia congenital	14.24	11.99	3	51136	12	79693237
Blood potassium decreased	14.21	11.99	6	51133	46506	79646743
Gastrointestinal haemorrhage	14.12	11.99	48	51091	147671	79545578
Dependence	14.09	11.99	12	51127	2410	79690839
Hyperkalaemia	14.01	11.99	33	51106	114365	79578884
Conjunctival haemorrhage	13.95	11.99	18	51121	5847	79687402
Diverticulitis	13.92	11.99	6	51133	45930	79647319
Accidental exposure to product	13.91	11.99	48	51091	31274	79661975
Intentional misuse of drug delivery system	13.86	11.99	3	51136	14	79693235
Hip arthroplasty	13.83	11.99	3	51136	35753	79657496
Testicular pain	13.61	11.99	11	51128	2054	79691195
Blood pressure decreased	13.59	11.99	27	51112	99439	79593810
Product contamination	13.50	11.99	9	51130	1251	79691998
Injection site vesicles	13.50	11.99	13	51126	3059	79690190
Intentional overdose	13.48	11.99	115	51024	105845	79587404
Cardiogenic shock	13.47	11.99	5	51134	41909	79651340
Bladder dilatation	13.36	11.99	11	51128	2108	79691141
Placental disorder	13.34	11.99	8	51131	925	79692324
Maternal drugs affecting foetus	13.34	11.99	10	51129	1673	79691576
Embolia cutis medicamentosa	13.31	11.99	7	51132	629	79692620
Viral titre decreased	13.23	11.99	3	51136	18	79693231
Developmental hip dysplasia	13.23	11.99	5	51134	204	79693045
Rash maculo-papular	13.17	11.99	10	51129	56068	79637181
Mixed anxiety and depressive disorder	12.99	11.99	6	51133	407	79692842
Dermal absorption impaired	12.96	11.99	3	51136	20	79693229
Lack of application site rotation	12.93	11.99	4	51135	88	79693161
Eye pain	12.92	11.99	4	51135	37574	79655675
Pharyngitis streptococcal	12.89	11.99	24	51115	10690	79682559
Ill-defined disorder	12.79	11.99	14	51125	65861	79627388
Arthritis	12.64	11.99	35	51104	114845	79578404
Pericardial effusion	12.55	11.99	7	51132	46230	79647019
Patient uncooperative	12.55	11.99	7	51132	707	79692542
Gastric cyst	12.52	11.99	4	51135	98	79693151
Lividity	12.46	11.99	6	51133	447	79692802
Psychotic disorder	12.35	11.99	56	51083	41346	79651903
Drug dependence, antepartum	12.27	11.99	3	51136	26	79693223
Kleptomania	12.27	11.99	3	51136	26	79693223
Urinary retention	12.26	11.99	70	51069	56560	79636689
Discoloured vomit	12.21	11.99	9	51130	1469	79691780
Tricuspid valve replacement	12.17	11.99	3	51136	27	79693222
Chest pain	12.15	11.99	119	51020	282185	79411064
Incorrect product administration duration	12.12	11.99	25	51114	11997	79681252
Urinary tract infection	12.11	11.99	115	51024	274397	79418852
Muscle rigidity	12.10	11.99	34	51105	19848	79673401
Cytokine release syndrome	12.08	11.99	4	51135	35994	79657255
False positive investigation result	12.05	11.99	8	51131	1104	79692145
Abdominal distension	12.04	11.99	38	51101	119612	79573637
Proteinuria	12.03	11.99	3	51136	32499	79660750

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug withdrawal syndrome neonatal	58.63	35.09	43	167	2076	87506
Poor feeding infant	38.65	35.09	13	197	97	89485

Pharmacologic Action:

Source	Code	Description
ATC	N02AE01	NERVOUS SYSTEM ANALGESICS OPIOIDS Oripavine derivatives
ATC	N07BC01	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS DRUGS USED IN ADDICTIVE DISORDERS Drugs used in opioid dependence
ATC	N07BC51	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS DRUGS USED IN ADDICTIVE DISORDERS Drugs used in opioid dependence
CHEBI has role	CHEBI:35482	narcotic analgesic
CHEBI has role	CHEBI:55322	mu-opioid agonists
CHEBI has role	CHEBI:59283	delta-opioid antagonists
CHEBI has role	CHEBI:167165	kappa-opioid receptor antagonists
MeSH PA	D000700	Analgesics
MeSH PA	D000701	Analgesics, Opioid
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D009292	Narcotic Antagonists
MeSH PA	D009294	Narcotics
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents
FDA MoA	N0000175685	Partial Opioid Agonists
FDA EPC	N0000175689	Partial Opioid Agonist
CHEBI has role	CHEBI:59282	kappa-opioid receptor agonists

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Opioid dependence	indication	75544000	DOID:2559
Severe pain	indication	76948002
Chronic pain	indication	82423001
Prevention of opioid abuse	indication	426928008
Acute postoperative pain	indication	107401000119105
Chronic Pain with Opioid Tolerance	indication
Opioid withdrawal	off-label use	87132004
Dependent drug abuse	contraindication	6525002
Alcohol withdrawal delirium	contraindication	8635005
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Asthenia	contraindication	13791008
Chronic disease of respiratory system	contraindication	17097001
Alcohol intoxication	contraindication	25702006
Orthostatic hypotension	contraindication	28651003
Hypercapnia	contraindication	29596007
Torsades de pointes	contraindication	31722008
Hypothyroidism	contraindication	40930008	DOID:1459
Paralytic ileus	contraindication	55525008	DOID:8442
Chronic type B viral hepatitis	contraindication	61977001
Benign intracranial hypertension	contraindication	68267002	DOID:11459
Urethral stricture	contraindication	76618002
Decreased respiratory function	contraindication	80954004
Injury of head	contraindication	82271004
Cor pulmonale	contraindication	83291003	DOID:8515
Disorder of biliary tract	contraindication	105997008	DOID:9741
Prolonged QT interval	contraindication	111975006
Chronic hepatitis C	contraindication	128302006
Liver function tests abnormal	contraindication	166603001
Drug-induced psychosis	contraindication	191483003	DOID:1742
Disease of liver	contraindication	235856003	DOID:409
Benign prostatic hyperplasia	contraindication	266569009
Lesion of brain	contraindication	301766008
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Hypoxia	contraindication	389086002
Respiratory insufficiency	contraindication	409623005
Central nervous system depression	contraindication	418072004
Congenital long QT syndrome	contraindication	442917000
Kyphoscoliosis with Respiratory Compromise	contraindication
Pain in Opioid Naive Patients	contraindication

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Postoperative pain associated with surgical procedures	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Simbadol	Zoetis Inc.	1
Zorbium	Elanco US Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.97	acidic
pKa2	8.88	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 12MG BASE;EQ 3MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	8603514	April 3, 2024	TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 2MG BASE;EQ 0.5MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	8603514	April 3, 2024	TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 4MG BASE;EQ 1MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	8603514	April 3, 2024	TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 8MG BASE;EQ 2MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	8603514	April 3, 2024	TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 80MG BASE/IMPLANT	PROBUPHINE	TITAN PHARMS	N204442	May 26, 2016	DISCN	IMPLANT	IMPLANTATION	7736665	April 25, 2024	FOR OPIOID DEPENDENCE
128MG/0.36ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8545832	June 6, 2025	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
16MG/0.32ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8545832	June 6, 2025	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
24MG/0.48ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8545832	June 6, 2025	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
32MG/0.64ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8545832	June 6, 2025	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
64MG/0.18ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8545832	June 6, 2025	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
8MG/0.16ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8545832	June 6, 2025	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
96MG/0.27ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8545832	June 6, 2025	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
128MG/0.36ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236755	July 31, 2026	A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
16MG/0.32ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236755	July 31, 2026	A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
24MG/0.48ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236755	July 31, 2026	A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
32MG/0.64ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236755	July 31, 2026	A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
64MG/0.18ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236755	July 31, 2026	A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
8MG/0.16ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236755	July 31, 2026	A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
96MG/0.27ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236755	July 31, 2026	A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
128MG/0.36ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236292	Jan. 10, 2027	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
16MG/0.32ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236292	Jan. 10, 2027	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
24MG/0.48ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236292	Jan. 10, 2027	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
32MG/0.64ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236292	Jan. 10, 2027	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
64MG/0.18ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236292	Jan. 10, 2027	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
8MG/0.16ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236292	Jan. 10, 2027	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
96MG/0.27ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8236292	Jan. 10, 2027	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
EQ 2.1MG BASE;EQ 0.3MG BASE	BUNAVAIL	BDSI	N205637	June 6, 2014	DISCN	FILM	BUCCAL	8147866	July 23, 2027	MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 2.1MG BASE;EQ 0.3MG BASE	BUNAVAIL	BDSI	N205637	June 6, 2014	DISCN	FILM	BUCCAL	9655843	July 23, 2027	TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE;EQ 0.7MG BASE	BUNAVAIL	BDSI	N205637	June 6, 2014	DISCN	FILM	BUCCAL	8147866	July 23, 2027	MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 4.2MG BASE;EQ 0.7MG BASE	BUNAVAIL	BDSI	N205637	June 6, 2014	DISCN	FILM	BUCCAL	9655843	July 23, 2027	TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE;EQ 1MG BASE	BUNAVAIL	BDSI	N205637	June 6, 2014	DISCN	FILM	BUCCAL	8147866	July 23, 2027	MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 6.3MG BASE;EQ 1MG BASE	BUNAVAIL	BDSI	N205637	June 6, 2014	DISCN	FILM	BUCCAL	9655843	July 23, 2027	TREATMENT OF OPIOID DEPENDENCE
EQ 0.075MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	8147866	July 23, 2027	TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.075MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9655843	July 23, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.15MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	8147866	July 23, 2027	TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.15MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9655843	July 23, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.3MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	8147866	July 23, 2027	TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.3MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9655843	July 23, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.45MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	8147866	July 23, 2027	TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.45MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9655843	July 23, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.6MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	8147866	July 23, 2027	TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.6MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9655843	July 23, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.75MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	8147866	July 23, 2027	TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.75MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9655843	July 23, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.9MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	8147866	July 23, 2027	TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE
EQ 0.9MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9655843	July 23, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.7MG BASE;EQ 0.18MG BASE	ZUBSOLV	OREXO US INC	N204242	Oct. 4, 2016	RX	TABLET	SUBLINGUAL	8658198	Dec. 3, 2027	SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 1.4MG BASE;EQ 0.36MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	8658198	Dec. 3, 2027	SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 11.4MG BASE;EQ 2.9MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	8658198	Dec. 3, 2027	SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 2.9MG BASE;EQ 0.71MG BASE	ZUBSOLV	OREXO US INC	N204242	June 4, 2015	RX	TABLET	SUBLINGUAL	8658198	Dec. 3, 2027	SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 5.7MG BASE;EQ 1.4MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	8658198	Dec. 3, 2027	SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 8.6MG BASE;EQ 2.1MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	8658198	Dec. 3, 2027	SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 12MG BASE;EQ 3MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	11135216	Aug. 7, 2029	TREATING OPIOID USE DISORDER
EQ 12MG BASE;EQ 3MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	9687454	Aug. 7, 2029	TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 2MG BASE;EQ 0.5MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	11135216	Aug. 7, 2029	TREATING OPIOID USE DISORDER
EQ 2MG BASE;EQ 0.5MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	9687454	Aug. 7, 2029	TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 4MG BASE;EQ 1MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	11135216	Aug. 7, 2029	TREATING OPIOID USE DISORDER
EQ 4MG BASE;EQ 1MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	9687454	Aug. 7, 2029	TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 8MG BASE;EQ 2MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	11135216	Aug. 7, 2029	TREATING OPIOID USE DISORDER
EQ 8MG BASE;EQ 2MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	9687454	Aug. 7, 2029	TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
EQ 12MG BASE;EQ 3MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	8475832	March 26, 2030	THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 2MG BASE;EQ 0.5MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	8475832	March 26, 2030	THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 4MG BASE;EQ 1MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	8475832	March 26, 2030	THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 8MG BASE;EQ 2MG BASE	SUBOXONE	INDIVIOR	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	8475832	March 26, 2030	THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
EQ 0.7MG BASE;EQ 0.18MG BASE	ZUBSOLV	OREXO US INC	N204242	Oct. 4, 2016	RX	TABLET	SUBLINGUAL	8470361	May 22, 2030	SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 1.4MG BASE;EQ 0.36MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	8470361	May 22, 2030	SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 11.4MG BASE;EQ 2.9MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	8470361	May 22, 2030	SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 2.9MG BASE;EQ 0.71MG BASE	ZUBSOLV	OREXO US INC	N204242	June 4, 2015	RX	TABLET	SUBLINGUAL	8470361	May 22, 2030	SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 5.7MG BASE;EQ 1.4MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	8470361	May 22, 2030	SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
EQ 8.6MG BASE;EQ 2.1MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	8470361	May 22, 2030	SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10198218	June 6, 2031	TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10592168	June 6, 2031	TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9272044	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9272044	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9272044	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9272044	June 6, 2031	TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9498432	June 6, 2031	IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9782402	June 6, 2031	TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9782402	June 6, 2031	TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9782402	June 6, 2031	TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9782402	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10198218	June 6, 2031	TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10592168	June 6, 2031	TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9272044	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9272044	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE COMPOSITION WITH 28 DAY DOSE DURATION
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9272044	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9272044	June 6, 2031	TREATING OPIOID ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9498432	June 6, 2031	IN SITU FORMATION OF SOLID BUPRENORPHINE COMPOSITION
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9782402	June 6, 2031	TREATING ADDICTION BY ONCE PER MONTH ADMINISTRATION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9782402	June 6, 2031	TREATING ADDICTION BY SUBCUTANEOUS INJECTION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9782402	June 6, 2031	TREATING ADDICTION WITH 100 MG OR 300 MG DOSE OF BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9782402	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID ADDICTION BY 100 MG OR 300 MG DOSE BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID ADDICTION BY ADMINISTRATION OF BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9827241	June 6, 2031	TREATING OPIOID DEPENDENCY BY SUBCUTANEOUSLY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8975270	Sept. 5, 2031	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8975270	Sept. 5, 2031	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8975270	Sept. 5, 2031	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8975270	Sept. 5, 2031	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE MONTHLY
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8921387	Jan. 6, 2032	TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8921387	Jan. 6, 2032	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8921387	Jan. 6, 2032	TREATING OPIOID DEPENDENCE BY ADMINISTERING BUPRENORPHINE
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8921387	Jan. 6, 2032	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
128MG/0.36ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10912772	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
128MG/0.36ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11110084	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
128MG/0.36ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9937164	July 26, 2032	A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
16MG/0.32ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10912772	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
16MG/0.32ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11110084	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
16MG/0.32ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9937164	July 26, 2032	A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
24MG/0.48ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10912772	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
24MG/0.48ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11110084	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
24MG/0.48ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9937164	July 26, 2032	A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
32MG/0.64ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10912772	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
32MG/0.64ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11110084	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
32MG/0.64ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9937164	July 26, 2032	A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
64MG/0.18ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10912772	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
64MG/0.18ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11110084	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
64MG/0.18ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9937164	July 26, 2032	A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
8MG/0.16ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10912772	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
8MG/0.16ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11110084	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
8MG/0.16ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9937164	July 26, 2032	A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
96MG/0.27ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10912772	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
96MG/0.27ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11110084	July 26, 2032	A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE
96MG/0.27ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	9937164	July 26, 2032	A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
EQ 0.7MG BASE;EQ 0.18MG BASE	ZUBSOLV	OREXO US INC	N204242	Oct. 4, 2016	RX	TABLET	SUBLINGUAL	11020388	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 1.4MG BASE;EQ 0.36MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	11020388	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 1.4MG BASE;EQ 0.36MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	11433066	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	11020387	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	11020388	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 11.4MG BASE;EQ 2.9MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	11433066	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE	ZUBSOLV	OREXO US INC	N204242	June 4, 2015	RX	TABLET	SUBLINGUAL	11020387	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE	ZUBSOLV	OREXO US INC	N204242	June 4, 2015	RX	TABLET	SUBLINGUAL	11020388	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 2.9MG BASE;EQ 0.71MG BASE	ZUBSOLV	OREXO US INC	N204242	June 4, 2015	RX	TABLET	SUBLINGUAL	11433066	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	11020387	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	11020388	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 5.7MG BASE;EQ 1.4MG BASE	ZUBSOLV	OREXO US INC	N204242	July 3, 2013	RX	TABLET	SUBLINGUAL	11433066	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	11020387	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	11020388	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 8.6MG BASE;EQ 2.1MG BASE	ZUBSOLV	OREXO US INC	N204242	Dec. 11, 2014	RX	TABLET	SUBLINGUAL	11433066	Sept. 18, 2032	USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
EQ 0.075MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9901539	Dec. 21, 2032	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.15MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9901539	Dec. 21, 2032	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.3MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9901539	Dec. 21, 2032	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.45MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9901539	Dec. 21, 2032	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.6MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9901539	Dec. 21, 2032	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.75MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9901539	Dec. 21, 2032	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
EQ 0.9MG BASE	BELBUCA	BDSI	N207932	Oct. 23, 2015	RX	FILM	BUCCAL	9901539	Dec. 21, 2032	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
100MG/0.5ML (100MG/0.5ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11000520	Nov. 6, 2035	TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11000520	Nov. 6, 2035	TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	10646484	June 22, 2038	TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
128MG/0.36ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	May 23, 2026	NEW PRODUCT
16MG/0.32ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	May 23, 2026	NEW PRODUCT
24MG/0.48ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	May 23, 2026	NEW PRODUCT
32MG/0.64ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	May 23, 2026	NEW PRODUCT
64MG/0.18ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	May 23, 2026	NEW PRODUCT
8MG/0.16ML (50MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	May 23, 2026	NEW PRODUCT
96MG/0.27ML (356MG/ML)	BRIXADI	BRAEBURN	N210136	May 23, 2023	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	May 23, 2026	NEW PRODUCT

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN	ANTAGONIST	Ki	9.01		WOMBAT-PK	CHEMBL
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	PARTIAL AGONIST	Ki	8.29		WOMBAT-PK	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN	ANTAGONIST	Ki	8.07		WOMBAT-PK
Nociceptin receptor	GPCR	P41146	OPRX_HUMAN		Ki	7.11		CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.10		CHEMBL
Mu-type opioid receptor	GPCR		OPRM_RAT		Ki	9.89		CHEMBL
Mu-type opioid receptor	GPCR		OPRM_CAVPO		Ki	9.40		CHEMBL
Delta-type opioid receptor	GPCR		OPRD_RAT		Ki	9.32		CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_CAVPO		Ki	9.30		CHEMBL

External reference:

ID	Source
4019644	VUID
N0000147737	NUI
D00836	KEGG_DRUG
53152-21-9	SECONDARY_CAS_RN
1819	RXNORM
C0006405	UMLSCUI
CHEBI:3216	CHEBI
CHEMBL560511	ChEMBL_ID
CHEMBL511142	ChEMBL_ID
CHEMBL2368861	ChEMBL_ID
D002047	MESH_DESCRIPTOR_UI
DB00921	DRUGBANK_ID
1670	IUPHAR_LIGAND_ID
3403	INN_ID
40D3SCR4GZ	UNII
644073	PUBCHEM_CID
11186	MMSL
257949	MMSL
27271	MMSL
31700	MMSL
4306	MMSL
d00840	MMSL
21066009	SNOMEDCT_US
31684002	SNOMEDCT_US
387173000	SNOMEDCT_US
4018880	VANDF
4019644	VANDF
001573	NDDF
004632	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Buprenorphine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0176	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0176	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0176	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0176	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0177	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0177	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0177	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine HCl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0177	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0188	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0188	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0188	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0188	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0189	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0189	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0189	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0189	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3239	PATCH, EXTENDED RELEASE	7.50 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3239	PATCH, EXTENDED RELEASE	7.50 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3656	PATCH, EXTENDED RELEASE	5 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3656	PATCH, EXTENDED RELEASE	5 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3657	PATCH, EXTENDED RELEASE	10 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3657	PATCH, EXTENDED RELEASE	10 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3658	PATCH, EXTENDED RELEASE	15 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3658	PATCH, EXTENDED RELEASE	15 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3659	PATCH, EXTENDED RELEASE	20 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3659	PATCH, EXTENDED RELEASE	20 ug	TRANSDERMAL	ANDA	31 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0121-1018	TABLET	2 mg	SUBLINGUAL	ANDA	31 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0121-2036	TABLET	8 mg	SUBLINGUAL	ANDA	31 sections
Buprenorphine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9246	INJECTION	0.32 mg	INTRAMUSCULAR	ANDA	16 sections
Buprenorphine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9246	INJECTION	0.32 mg	INTRAMUSCULAR	ANDA	16 sections