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
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	1711.48	13.68	404	31646	3415	56256602
Product adhesion issue	1703.08	13.68	415	31635	4068	56255949
Drug withdrawal syndrome	1456.91	13.68	549	31501	25308	56234709
Application site erythema	1202.73	13.68	316	31734	4284	56255733
Application site rash	938.71	13.68	228	31822	2195	56257822
Inadequate analgesia	719.71	13.68	188	31862	2483	56257534
Application site pain	710.95	13.68	202	31848	3718	56256299
Application site vesicles	704.21	13.68	162	31888	1203	56258814
Drug dependence	603.40	13.68	282	31768	22251	56237766
Application site burn	562.71	13.68	122	31928	665	56259352
Drug abuse	489.43	13.68	362	31688	67248	56192769
Drug withdrawal syndrome neonatal	476.81	13.68	128	31922	1888	56258129
Application site irritation	367.74	13.68	100	31950	1552	56258465
Maternal exposure during pregnancy	332.99	13.68	471	31579	189082	56070935
Wrong technique in product usage process	245.59	13.68	228	31822	57940	56202077
Application site scar	235.57	13.68	48	32002	182	56259835
Foetal exposure during pregnancy	235.28	13.68	177	31873	33646	56226371
Substance abuse	232.51	13.68	90	31960	4435	56255582
Application site discharge	226.96	13.68	44	32006	120	56259897
Exposure during pregnancy	221.84	13.68	327	31723	136015	56124002
Application site erosion	203.23	13.68	41	32009	146	56259871
Application site exfoliation	187.12	13.68	43	32007	317	56259700
Application site dryness	182.48	13.68	37	32013	136	56259881
Application site discolouration	169.60	13.68	46	32004	706	56259311
Withdrawal syndrome	154.27	13.68	108	31942	18354	56241663
Premature delivery	148.11	13.68	123	31927	26937	56233080
Application site urticaria	139.95	13.68	32	32018	230	56259787
Abortion spontaneous	128.54	13.68	141	31909	43612	56216405
Product solubility abnormal	122.60	13.68	36	32014	746	56259271
Product physical issue	118.38	13.68	56	31994	4526	56255491
Application site reaction	113.82	13.68	33	32017	653	56259364
Application site swelling	111.55	13.68	31	32019	523	56259494
Product packaging quantity issue	110.98	13.68	37	32013	1177	56258840
Rheumatoid arthritis	110.54	13.68	40	32010	382564	55877453
Overdose	102.93	13.68	202	31848	105628	56154389
Respiratory depression	99.83	13.68	71	31979	12364	56247653
Hyperhidrosis	99.37	13.68	186	31864	93902	56166115
Product administered at inappropriate site	98.94	13.68	42	32008	2628	56257389
Toxicity to various agents	97.43	13.68	315	31735	224249	56035768
Placental disorder	96.92	13.68	35	32015	1418	56258599
Somnolence	96.57	13.68	256	31794	163157	56096860
Inappropriate schedule of product administration	94.56	13.68	170	31880	83217	56176800
Placental hypertrophy	90.61	13.68	14	32036	0	56260017
Therapeutic product effect increased	88.11	13.68	30	32020	1019	56258998
Drug screen positive	85.41	13.68	41	32009	3423	56256594
Blepharospasm	83.12	13.68	40	32010	3358	56256659
Hyperaesthesia	82.64	13.68	55	31995	8602	56251415
Jaundice neonatal	81.68	13.68	27	32023	836	56259181
Yawning	80.24	13.68	28	32022	1025	56258992
Intentional product misuse	79.96	13.68	121	31929	51383	56208634
Arthropathy	79.86	13.68	10	32040	200265	56059752
Maternal exposure during breast feeding	77.48	13.68	39	32011	3608	56256409
Systemic lupus erythematosus	76.88	13.68	7	32043	180071	56079946
Drug use disorder	73.85	13.68	41	32009	4628	56255389
Oral administration complication	71.77	13.68	16	32034	101	56259916
Treatment failure	71.74	13.68	7	32043	170385	56089632
Drug delivery system removal	71.19	13.68	11	32039	0	56260017
Abortion induced	70.42	13.68	52	31998	9593	56250424
Accidental exposure to product by child	69.88	13.68	26	32024	1147	56258870
Injection site pain	68.64	13.68	183	31867	116935	56143082
Application site ulcer	68.37	13.68	15	32035	87	56259930
Infusion related reaction	67.12	13.68	18	32032	208913	56051104
Product physical consistency issue	66.79	13.68	21	32029	552	56259465
Euphoric mood	65.48	13.68	37	32013	4321	56255696
Exposure via breast milk	65.47	13.68	28	32022	1784	56258233
Application site scab	63.89	13.68	16	32034	176	56259841
Sinusitis	61.65	13.68	18	32032	197563	56062454
Alopecia	60.70	13.68	47	32003	293411	55966606
Application site dermatitis	59.98	13.68	15	32035	164	56259853
Taste disorder	59.13	13.68	47	32003	9668	56250349
Stress cardiomyopathy	58.75	13.68	44	32006	8292	56251725
Breakthrough pain	58.64	13.68	23	32027	1173	56258844
Drug screen negative	58.48	13.68	16	32034	254	56259763
Rhesus incompatibility	58.46	13.68	13	32037	81	56259936
Contraindicated product administered	58.06	13.68	17	32033	186269	56073748
Foetal growth restriction	58.06	13.68	41	32009	7058	56252959
Injection site extravasation	57.24	13.68	43	32007	8141	56251876
Joint swelling	56.72	13.68	49	32001	289751	55970266
Injection site infection	56.43	13.68	25	32025	1735	56258282
Selective abortion	55.90	13.68	14	32036	154	56259863
Hallucination	51.64	13.68	97	31953	49052	56210965
Application site haemorrhage	50.61	13.68	20	32030	1041	56258976
Swelling	50.07	13.68	38	32012	239733	56020284
Disturbance in attention	49.85	13.68	76	31974	32464	56227553
Hepatic enzyme increased	49.25	13.68	18	32032	171366	56088651
Glossodynia	49.21	13.68	13	32037	152445	56107572
Pyrexia	47.60	13.68	105	31945	418668	55841349
Miosis	46.92	13.68	35	32015	6557	56253460
Fatigue	46.40	13.68	262	31788	788290	55471727
Device leakage	45.71	13.68	34	32016	6341	56253676
Product dispensing issue	44.79	13.68	11	32039	111	56259906
Suicidal ideation	44.19	13.68	100	31950	57642	56202375
Skin irritation	43.29	13.68	37	32013	8418	56251599
Infection	42.73	13.68	31	32019	200175	56059842
Nasopharyngitis	42.43	13.68	38	32012	220921	56039096
Subchondral insufficiency fracture	41.66	13.68	9	32041	48	56259969
Injection site cellulitis	41.63	13.68	18	32032	1178	56258839
Intentional underdose	41.56	13.68	20	32030	1678	56258339
Prescription drug used without a prescription	41.55	13.68	21	32029	1959	56258058
Alcohol abuse	41.51	13.68	21	32029	1963	56258054
Dermatitis contact	41.42	13.68	38	32012	9489	56250528
Drug detoxification	41.10	13.68	11	32039	160	56259857
Poor feeding infant	41.08	13.68	12	32038	244	56259773
Drug diversion	41.04	13.68	16	32034	803	56259214
Diarrhoea	40.92	13.68	206	31844	638301	55621716
Epilepsy	40.17	13.68	60	31990	25171	56234846
Defaecation disorder	39.78	13.68	15	32035	687	56259330
Bradycardia foetal	39.53	13.68	13	32037	396	56259621
Abdominal discomfort	39.01	13.68	61	31989	277213	55982804
17 ketosteroids urine abnormal	38.83	13.68	6	32044	0	56260017
Impaired reasoning	38.62	13.68	9	32041	71	56259946
Application site odour	38.53	13.68	8	32042	34	56259983
Low birth weight baby	37.49	13.68	30	32020	6228	56253789
Application site induration	36.40	13.68	6	32044	3	56260014
Application site inflammation	36.38	13.68	12	32038	369	56259648
Arthralgia	36.15	13.68	155	31895	501514	55758503
Accidental overdose	35.98	13.68	51	31999	20410	56239607
Respiratory arrest	35.40	13.68	63	31987	30562	56229455
Echocardiogram abnormal	34.19	13.68	16	32034	1261	56258756
Therapy naive	33.48	13.68	7	32043	31	56259986
Neutropenia	33.08	13.68	25	32025	158142	56101875
Cough	32.18	13.68	62	31988	259899	56000118
Off label use	31.43	13.68	187	31863	555993	55704024
Premature baby	31.04	13.68	46	32004	19159	56240858
Musculoskeletal stiffness	30.94	13.68	26	32024	155981	56104036
Application site bruise	30.68	13.68	10	32040	296	56259721
Febrile neutropenia	30.45	13.68	11	32039	105534	56154483
Injection site abscess	30.30	13.68	14	32036	1072	56258945
Hypersensitivity	30.15	13.68	63	31987	256345	56003672
Haemoglobin decreased	29.62	13.68	20	32030	134117	56125900
Vomiting	29.59	13.68	422	31628	497806	55762211
Application site papules	29.22	13.68	7	32043	63	56259954
Platelet count decreased	29.18	13.68	12	32038	106371	56153646
Unresponsive to stimuli	28.93	13.68	59	31991	31666	56228351
Gastrointestinal disorder	28.89	13.68	14	32036	112688	56147329
White blood cell count decreased	28.89	13.68	18	32032	125972	56134045
Impaired healing	28.79	13.68	7	32043	86834	56173183
Product colour issue	27.57	13.68	11	32039	587	56259430
Foetal malformation	26.45	13.68	8	32042	184	56259833
Eyelid retraction	26.38	13.68	6	32044	42	56259975
Monoplegia	26.24	13.68	18	32032	2956	56257061
Hypertension	25.49	13.68	64	31986	244214	56015803
Maternal drugs affecting foetus	25.49	13.68	22	32028	5071	56254946
Faecaloma	25.42	13.68	26	32024	7415	56252602
Endocarditis staphylococcal	24.98	13.68	9	32041	362	56259655
Faeces soft	24.40	13.68	21	32029	4821	56255196
Neurosis	24.38	13.68	8	32042	242	56259775
Thrombocytopenia	24.30	13.68	25	32025	136199	56123818
Application site perspiration	24.13	13.68	5	32045	21	56259996
Genitourinary symptom	24.13	13.68	6	32044	64	56259953
Tooth hypoplasia	24.04	13.68	6	32044	65	56259952
Victim of sexual abuse	23.93	13.68	10	32040	601	56259416
Judgement impaired	23.90	13.68	10	32040	603	56259414
Therapeutic response shortened	23.73	13.68	28	32022	9358	56250659
Irritable bowel syndrome	23.73	13.68	5	32045	68453	56191564
Accidental poisoning	23.44	13.68	10	32040	633	56259384
Vulvar basal cell carcinoma	23.41	13.68	5	32045	25	56259992
Dermatitis allergic	23.34	13.68	34	32016	13944	56246073
Psoriatic arthropathy	22.59	13.68	7	32043	74001	56186016
Foetal death	22.35	13.68	26	32024	8561	56251456
Maternal use of illicit drugs	22.23	13.68	4	32046	6	56260011
Extra dose administered	22.19	13.68	21	32029	5452	56254565
Blood cholesterol increased	21.91	13.68	7	32043	72572	56187445
Product dose omission issue	21.86	13.68	53	31997	204700	56055317
Ill-defined disorder	21.81	13.68	6	32044	68537	56191480
Congenital coronary artery malformation	21.77	13.68	6	32044	98	56259919
Psoriasis	21.59	13.68	13	32037	92679	56167338
Injection site ulcer	21.51	13.68	9	32041	543	56259474
Pneumonia	21.33	13.68	140	31910	406958	55853059
Agitation	21.04	13.68	75	31975	55961	56204056
Product contamination	21.02	13.68	9	32041	575	56259442
Somnolence neonatal	20.92	13.68	6	32044	114	56259903
Focal segmental glomerulosclerosis	20.82	13.68	12	32038	1454	56258563
Depressed level of consciousness	20.74	13.68	75	31975	56358	56203659
Conjunctival haemorrhage	20.44	13.68	16	32034	3217	56256800
Application site infection	20.13	13.68	5	32045	53	56259964
Injection site oedema	20.08	13.68	11	32039	1209	56258808
Stillbirth	19.94	13.68	21	32029	6193	56253824
Sedation	19.92	13.68	54	31996	34800	56225217
Nausea	19.88	13.68	572	31478	763606	55496411
Weight increased	19.71	13.68	66	31984	229637	56030380
Product substitution issue	19.46	13.68	32	32018	14567	56245450
Gastrointestinal hypomotility	19.45	13.68	10	32040	967	56259050
Pupil constriction procedure	19.42	13.68	3	32047	0	56260017
Small for dates baby	19.21	13.68	16	32034	3514	56256503
Urinary incontinence	19.13	13.68	48	32002	29537	56230480
Neonatal aspiration	19.07	13.68	6	32044	158	56259859
Radial nerve palsy	18.99	13.68	8	32042	491	56259526
Migraine	18.55	13.68	98	31952	86699	56173318
Cerebral vasoconstriction	18.23	13.68	10	32040	1102	56258915
Enlarged uvula	18.20	13.68	6	32044	184	56259833
Injection site erosion	18.18	13.68	5	32045	81	56259936
Product odour abnormal	18.16	13.68	10	32040	1111	56258906
Wound	18.13	13.68	32	32018	138772	56121245
Condition aggravated	17.86	13.68	119	31931	344779	55915238
Application site pustules	17.84	13.68	4	32046	26	56259991
Substance dependence	17.79	13.68	6	32044	198	56259819
Product prescribing error	17.56	13.68	40	32010	23146	56236871
Application site discomfort	17.34	13.68	7	32043	385	56259632
Drug interaction	17.26	13.68	189	31861	209566	56050451
Cataract	17.24	13.68	4	32046	51243	56208774
Premature labour	17.14	13.68	27	32023	11855	56248162
Type 2 diabetes mellitus	17.13	13.68	3	32047	46859	56213158
Hypersomnia	16.84	13.68	32	32018	16309	56243708
Therapy non-responder	16.69	13.68	7	32043	61348	56198669
Bruxism	16.50	13.68	14	32036	3152	56256865
Interstitial lung disease	16.37	13.68	6	32044	57057	56202960
Constipation	16.18	13.68	181	31869	201762	56058255
Sinus arrhythmia	16.15	13.68	10	32040	1381	56258636
Pancytopenia	16.14	13.68	16	32034	88699	56171318
Delirium	16.04	13.68	57	31993	42460	56217557
Mental disorder	16	13.68	39	32011	23565	56236452
Disease progression	15.87	13.68	22	32028	105151	56154866
Heart rate abnormal	15.86	13.68	16	32034	4487	56255530
Oral mucosal blistering	15.86	13.68	17	32033	5117	56254900
Dyspnoea	15.79	13.68	240	31810	592337	55667680
Tremor neonatal	15.74	13.68	5	32045	136	56259881
Confusional state	15.52	13.68	184	31866	207971	56052046
Influenza	15.33	13.68	19	32031	95242	56164775
Application site laceration	15.26	13.68	3	32047	9	56260008
Repetitive strain injury	15.12	13.68	5	32045	155	56259862
Cardio-respiratory arrest	15.09	13.68	67	31983	55254	56204763
Product quality issue	15.07	13.68	46	32004	31690	56228327
Lack of application site rotation	15.02	13.68	3	32047	10	56260007
Product size issue	14.99	13.68	6	32044	323	56259694
Application site warmth	14.79	13.68	5	32045	166	56259851
Neonatal respiratory distress	14.71	13.68	6	32044	339	56259678
Neutrophil count decreased	14.70	13.68	5	32045	49817	56210200
Femoral neck fracture	14.60	13.68	20	32030	7751	56252266
Adjacent segment degeneration	14.59	13.68	3	32047	12	56260005
Bronchitis	14.57	13.68	26	32024	112285	56147732
Persistent depressive disorder	14.53	13.68	8	32042	888	56259129
Therapeutic response increased	14.39	13.68	6	32044	359	56259658
Bradypnoea	14.36	13.68	13	32037	3190	56256827
Pharyngitis streptococcal	14.28	13.68	22	32028	9476	56250541
Application site paraesthesia	14.20	13.68	4	32046	71	56259946
Premature separation of placenta	14.01	13.68	10	32040	1750	56258267
Ankyloglossia congenital	13.93	13.68	5	32045	199	56259818
Glomerular filtration rate	13.89	13.68	3	32047	16	56260001
Dental discomfort	13.86	13.68	6	32044	394	56259623
Knee arthroplasty	13.84	13.68	4	32046	44255	56215762
Application site hypersensitivity	13.83	13.68	5	32045	203	56259814
Feeling of body temperature change	13.83	13.68	15	32035	4574	56255443
Dyspnoea exertional	13.70	13.68	7	32043	54682	56205335

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	1700.60	15.05	1051	29399	86707	31580187
Drug withdrawal syndrome	1680.26	15.05	643	29807	18107	31648787
Drug dependence	1326.43	15.05	572	29878	22007	31644887
Intentional product misuse	773.73	15.05	471	29979	37480	31629414
Substance abuse	602.64	15.05	235	30215	6923	31659971
Product adhesion issue	578.74	15.05	157	30293	1368	31665526
Drug withdrawal syndrome neonatal	516.91	15.05	174	30276	3318	31663576
Miosis	501.93	15.05	217	30233	8353	31658541
Toxicity to various agents	487.61	15.05	725	29725	180762	31486132
Injection site pain	443.54	15.05	322	30128	34312	31632582
Application site pruritus	378.75	15.05	109	30341	1201	31665693
Drug use disorder	314.87	15.05	125	30325	3858	31663036
Application site erythema	287.28	15.05	99	30351	2030	31664864
Application site rash	285.58	15.05	78	30372	698	31666196
Intentional product use issue	281.79	15.05	289	30161	49058	31617836
Inadequate analgesia	271.87	15.05	101	30349	2592	31664302
Withdrawal syndrome	257.85	15.05	153	30297	11564	31655330
Alcohol abuse	239.40	15.05	107	30343	4457	31662437
Overdose	236.01	15.05	345	30105	84319	31582575
Coma	208.13	15.05	226	30224	40924	31625970
Foetal exposure during pregnancy	205.87	15.05	224	30226	40652	31626242
Myelopathy	204.13	15.05	78	30372	2167	31664727
Application site burn	202.49	15.05	46	30404	171	31666723
Respiratory depression	185.71	15.05	135	30315	14375	31652519
Somnolence	180.53	15.05	334	30116	99111	31567783
Injection site infection	179.57	15.05	57	30393	894	31666000
Drug screen positive	169.68	15.05	80	30370	3772	31663122
Application site vesicles	164.76	15.05	47	30403	500	31666394
Injection site abscess	153.93	15.05	48	30402	708	31666186
Application site pain	152.69	15.05	59	30391	1690	31665204
Injection site ulcer	148.49	15.05	37	30413	221	31666673
Drug detoxification	138.82	15.05	34	30416	187	31666707
Wrong technique in product usage process	137.80	15.05	165	30285	33178	31633716
Accidental overdose	137.67	15.05	125	30325	18225	31648669
Asphyxia	136.77	15.05	79	30371	5672	31661222
Injection site erythema	135.81	15.05	112	30338	14350	31652544
Drug delivery system removal	124.93	15.05	21	30429	0	31666894
Maternal exposure during breast feeding	106.53	15.05	44	30406	1505	31665389
Injection site extravasation	102.19	15.05	50	30400	2560	31664334
Brain oedema	99.36	15.05	89	30361	12743	31654151
Application site irritation	98.82	15.05	33	30417	612	31666282
Compartment syndrome	92.27	15.05	47	30403	2624	31664270
Febrile neutropenia	87.78	15.05	8	30442	121841	31545053
Drug screen negative	87.09	15.05	22	30428	140	31666754
Agitation	85.91	15.05	172	30278	53997	31612897
Quadriparesis	82.97	15.05	36	30414	1394	31665500
Injection site erosion	82.33	15.05	19	30431	77	31666817
Injection site necrosis	80.53	15.05	25	30425	363	31666531
Pyrexia	79.09	15.05	106	30344	303734	31363160
Accidental poisoning	75.91	15.05	28	30422	703	31666191
Accidental exposure to product by child	74.89	15.05	34	30416	1468	31665426
Application site reaction	74.81	15.05	24	30426	390	31666504
Jaundice neonatal	73.06	15.05	32	30418	1268	31665626
Euphoric mood	72.70	15.05	50	30400	4870	31662024
Brachial artery entrapment syndrome	71.39	15.05	12	30438	0	31666894
Diarrhoea	71.22	15.05	145	30305	352264	31314630
Aggression	69.69	15.05	127	30323	37164	31629730
Logorrhoea	69.22	15.05	37	30413	2282	31664612
Drug diversion	68.50	15.05	27	30423	816	31666078
Hyperhidrosis	68.00	15.05	179	30271	67214	31599680
Poor feeding infant	67.67	15.05	23	30427	451	31666443
Atrial fibrillation	66.68	15.05	14	30436	113769	31553125
Pneumonia	66.01	15.05	140	30310	335172	31331722
Prescription drug used without a prescription	63.94	15.05	30	30420	1398	31665496
Application site dryness	63.67	15.05	14	30436	43	31666851
Bradypnoea	63.26	15.05	36	30414	2511	31664383
Dysarthria	62.32	15.05	111	30339	31906	31634988
Inappropriate schedule of product administration	61.81	15.05	145	30305	50678	31616216
Cluster headache	61.37	15.05	22	30428	508	31666386
Injection site discharge	59.99	15.05	15	30435	91	31666803
Spinal shock	59.86	15.05	13	30437	37	31666857
Intentional removal of drug delivery system by patient	59.49	15.05	10	30440	0	31666894
Injection site vesicles	59.32	15.05	22	30428	561	31666333
Cough	58.80	15.05	28	30422	134786	31532108
Platelet count decreased	58.09	15.05	17	30433	110418	31556476
Congenital multiplex arthrogryposis	56.47	15.05	13	30437	52	31666842
Dermo-hypodermitis	54.87	15.05	18	30432	315	31666579
Application site urticaria	54.11	15.05	13	30437	65	31666829
Exposure via breast milk	53.62	15.05	29	30421	1831	31665063
Deafness neurosensory	53.36	15.05	33	30417	2683	31664211
Pulmonary oedema	53.06	15.05	126	30324	44376	31622518
Tremor neonatal	51.94	15.05	18	30432	375	31666519
Death	51.38	15.05	550	29900	360019	31306875
Low birth weight baby	51.31	15.05	47	30403	6923	31659971
Product dispensing issue	50.34	15.05	10	30440	15	31666879
Premature baby	49.28	15.05	73	30377	17993	31648901
Poisoning	48.88	15.05	55	30395	10336	31656558
White blood cell count decreased	48.70	15.05	12	30438	87386	31579508
Hypotension	48.59	15.05	76	30374	204542	31462352
Application site swelling	47.99	15.05	15	30435	223	31666671
Drug abuser	47.13	15.05	35	30415	3845	31663049
Rhabdomyolysis	46.88	15.05	151	30299	63430	31603464
Injection site cellulitis	46.63	15.05	18	30432	514	31666380
Impaired driving ability	46.51	15.05	29	30421	2392	31664502
Therapeutic product effect increased	45.99	15.05	19	30431	650	31666244
Injection site warmth	45.23	15.05	26	30424	1848	31665046
Sarcopenia	45.10	15.05	16	30434	358	31666536
Application site exfoliation	45.01	15.05	12	30438	97	31666797
Product solubility abnormal	44.76	15.05	17	30433	464	31666430
Application site discolouration	44.55	15.05	14	30436	212	31666682
Cardiac failure congestive	44.03	15.05	11	30439	79376	31587518
Endocarditis staphylococcal	42.89	15.05	16	30434	415	31666479
Injection site irritation	42.71	15.05	21	30429	1086	31665808
Disorientation	42.13	15.05	92	30358	30652	31636242
Neutropenia	41.70	15.05	44	30406	140320	31526574
Oral administration complication	40.98	15.05	10	30440	54	31666840
Aptyalism	40.61	15.05	14	30436	287	31666607
Fatigue	40.04	15.05	176	30274	335030	31331864
Hepatitis C	39.66	15.05	50	30400	10580	31656314
Anaemia	39.57	15.05	92	30358	213430	31453464
Restlessness	39.20	15.05	76	30374	23285	31643609
Product dose omission issue	38.79	15.05	27	30423	105559	31561335
Application site erosion	38.64	15.05	10	30440	71	31666823
Hallucination	38.64	15.05	115	30335	46295	31620599
Haemoglobin decreased	38.58	15.05	31	30419	112644	31554250
Dyspnoea	38.27	15.05	185	30265	343294	31323600
Application site hypersensitivity	38.14	15.05	11	30439	122	31666772
Application site scar	37.88	15.05	8	30442	19	31666875
Endocarditis	37.14	15.05	37	30413	6048	31660846
Therapeutic product effect decreased	37.10	15.05	89	30361	31533	31635361
Acute kidney injury	37.05	15.05	141	30309	279573	31387321
Intentional underdose	37.03	15.05	16	30434	613	31666281
Decreased gait velocity	36.83	15.05	11	30439	139	31666755
Application site discharge	36.48	15.05	11	30439	144	31666750
Congestive hepatopathy	36.39	15.05	22	30428	1717	31665177
Drug interaction	36.33	15.05	332	30118	208211	31458683
Disease progression	36.15	15.05	21	30429	90443	31576451
Product packaging quantity issue	36.03	15.05	17	30433	802	31666092
Housebound	35.76	15.05	12	30438	226	31666668
Neuropathy peripheral	35.67	15.05	14	30436	75635	31591259
Skin irritation	35.21	15.05	32	30418	4665	31662229
Prescription form tampering	35.06	15.05	14	30436	438	31666456
Asthenia	33.99	15.05	107	30343	224648	31442246
Cerebrovascular accident	33.88	15.05	17	30433	79467	31587427
Injection site swelling	33.81	15.05	45	30405	10042	31656852
Pleural effusion	33.50	15.05	15	30435	74905	31591989
Arthralgia	33.35	15.05	59	30391	151365	31515529
Injection site pruritus	32.98	15.05	35	30415	6159	31660735
Infusion related reaction	32.41	15.05	4	30446	48051	31618843
Injection site inflammation	32.05	15.05	15	30435	695	31666199
Incorrect route of product administration	31.59	15.05	47	30403	11626	31655268
COVID-19	31.57	15.05	7	30443	54814	31612080
Depressed level of consciousness	31.51	15.05	95	30355	38506	31628388
Interstitial lung disease	31.28	15.05	10	30440	61393	31605501
Bradyphrenia	31.06	15.05	29	30421	4375	31662519
Respiratory arrest	30.91	15.05	74	30376	26183	31640711
Epistaxis	30.64	15.05	7	30443	53700	31613194
Glomerulonephritis acute	30.26	15.05	9	30441	112	31666782
Sedation	29.76	15.05	60	30390	18905	31647989
Malignant neoplasm progression	29.27	15.05	20	30430	78978	31587916
Foetal distress syndrome	29.26	15.05	16	30434	1032	31665862
Feeding intolerance	29.10	15.05	9	30441	129	31666765
Substance use	28.86	15.05	13	30437	551	31666343
Breech presentation	28.66	15.05	9	30441	136	31666758
Vestibular ischaemia	28.48	15.05	6	30444	14	31666880
Product use in unapproved indication	28.42	15.05	32	30418	99139	31567755
Road traffic accident	28.34	15.05	54	30396	16327	31650567
Product administered at inappropriate site	27.71	15.05	19	30431	1841	31665053
Suicidal ideation	27.30	15.05	87	30363	36319	31630575
Psoriasis	26.83	15.05	6	30444	46713	31620181
Substance dependence	26.80	15.05	11	30439	370	31666524
Rash	26.35	15.05	102	30348	201384	31465510
Ear deformity acquired	26.28	15.05	5	30445	5	31666889
Blood glucose increased	26.12	15.05	13	30437	61070	31605824
Aspartate aminotransferase increased	25.85	15.05	14	30436	62705	31604189
Hyponatraemia	25.63	15.05	20	30430	73779	31593115
Hyperkalaemia	25.61	15.05	15	30435	64336	31602558
Troponin T increased	25.59	15.05	17	30433	1563	31665331
Respiratory rate decreased	25.59	15.05	19	30431	2086	31664808
Thrombosis	25.53	15.05	6	30444	45145	31621749
Application site scab	25.49	15.05	7	30443	64	31666830
Haemorrhage	25.40	15.05	7	30443	47327	31619567
Blood creatinine increased	25.25	15.05	29	30421	89049	31577845
Thrombocytopenia	25.22	15.05	63	30387	142684	31524210
Electrocardiogram T wave alternans	24.26	15.05	5	30445	10	31666884
Wrong dose	23.88	15.05	11	30439	491	31666403
Vestibular disorder	23.65	15.05	14	30436	1051	31665843
Agitation neonatal	23.44	15.05	14	30436	1069	31665825
Joint swelling	23.41	15.05	11	30439	53420	31613474
Dependence	23.31	15.05	14	30436	1080	31665814
Hypoventilation	23.15	15.05	21	30429	3053	31663841
Anxiety	22.99	15.05	158	30292	90875	31576019
Injection site bruising	22.86	15.05	33	30417	7942	31658952
Clumsiness	22.85	15.05	16	30434	1603	31665291
Coronary artery disease	22.61	15.05	8	30442	46079	31620815
Product physical issue	22.28	15.05	18	30432	2237	31664657
Joint hyperextension	22.15	15.05	7	30443	108	31666786
Mastication disorder	22.10	15.05	14	30436	1187	31665707
Treatment failure	21.95	15.05	6	30444	40786	31626108
Application site haemorrhage	21.85	15.05	10	30440	440	31666454
Dehydration	21.48	15.05	52	30398	119059	31547835
Plasma cell myeloma	21.36	15.05	14	30436	56517	31610377
Altered state of consciousness	21.28	15.05	56	30394	20995	31645899
Prostate cancer	21.25	15.05	5	30445	37596	31629298
Chronic actinic dermatitis	20.81	15.05	5	30445	25	31666869
Coordination abnormal	20.78	15.05	30	30420	7221	31659673
Herpes zoster	20.77	15.05	3	30447	31990	31634904
Substance use disorder	20.49	15.05	10	30440	509	31666385
Hypoxic-ischaemic encephalopathy	20.45	15.05	23	30427	4318	31662576
Accidental death	20.45	15.05	17	30433	2200	31664694
Product use issue	20.39	15.05	108	30342	56651	31610243
Neonatal aspiration	20.30	15.05	6	30444	73	31666821
International normalised ratio increased	20.30	15.05	9	30441	45214	31621680
Off label use	20.18	15.05	225	30225	347049	31319845
Myocardial infarction	20.09	15.05	50	30400	113404	31553490
Accidental exposure to product	20.02	15.05	38	30412	11457	31655437
Unresponsive to stimuli	19.66	15.05	62	30388	25738	31641156
Psychotic disorder	19.26	15.05	56	30394	22237	31644657
Rheumatoid arthritis	19.23	15.05	11	30439	47798	31619096
Renal failure	19.11	15.05	58	30392	123272	31543622
Pulmonary congestion	19.10	15.05	40	30410	12943	31653951
Back pain	18.76	15.05	49	30401	109364	31557530
Product substitution issue	18.72	15.05	33	30417	9399	31657495
Therapy naive	18.69	15.05	5	30445	41	31666853
Micrognathia	18.60	15.05	8	30442	303	31666591
Delirium	18.59	15.05	84	30366	41337	31625557
Diabetes mellitus	18.28	15.05	9	30441	42547	31624347
Laryngomalacia	18.26	15.05	8	30442	317	31666577
Product contamination	18.22	15.05	10	30440	650	31666244
Disturbance in attention	18.08	15.05	55	30395	22395	31644499
Brief psychotic disorder with marked stressors	17.97	15.05	7	30443	205	31666689
Emotional poverty	17.87	15.05	9	30441	490	31666404
Injection site ischaemia	17.85	15.05	3	30447	0	31666894
Application site odour	17.85	15.05	3	30447	0	31666894
Dementia with Lewy bodies	17.72	15.05	10	30440	686	31666208
Weight increased	17.63	15.05	33	30417	82914	31583980
Persecutory delusion	17.58	15.05	16	30434	2336	31664558
Pancytopenia	17.47	15.05	36	30414	87280	31579614
Drug effect less than expected	17.41	15.05	9	30441	518	31666376
Blood bilirubin increased	17.40	15.05	6	30444	35130	31631764
Application site ulcer	17.37	15.05	4	30446	16	31666878
Hypertension	17.28	15.05	64	30386	128036	31538858
Embolia cutis medicamentosa	17.27	15.05	7	30443	228	31666666
Septic pulmonary embolism	17.18	15.05	4	30446	17	31666877
Alcohol interaction	17.09	15.05	17	30433	2772	31664122
Victim of crime	17.06	15.05	8	30442	372	31666522
Infection	17.06	15.05	33	30417	81898	31584996
Hallucination, visual	16.98	15.05	43	30407	15751	31651143
Bronchitis	16.91	15.05	8	30442	38709	31628185
Neutrophil count decreased	16.84	15.05	12	30438	46382	31620512
Multiple cardiac defects	16.68	15.05	5	30445	64	31666830
Rectal haemorrhage	16.65	15.05	7	30443	36297	31630597
Anaphylactic reaction	16.56	15.05	4	30446	29549	31637345
Deafness bilateral	16.46	15.05	11	30439	1022	31665872
Poisoning deliberate	16.30	15.05	27	30423	7317	31659577
Respiratory failure	16.22	15.05	47	30403	101402	31565492
Abdominal distension	16.05	15.05	15	30435	50669	31616225
Cyanosis	15.94	15.05	35	30415	11700	31655194
Incoherent	15.89	15.05	20	30430	4224	31662670
Gun shot wound	15.88	15.05	11	30439	1083	31665811
Product colour issue	15.86	15.05	8	30442	437	31666457
Mydriasis	15.78	15.05	25	30425	6527	31660367
Dermal absorption impaired	15.77	15.05	3	30447	3	31666891
Administration site abscess sterile	15.77	15.05	3	30447	3	31666891
Eschar	15.77	15.05	9	30441	631	31666263
Alcohol withdrawal syndrome	15.66	15.05	12	30438	1381	31665513
Injection site scab	15.38	15.05	4	30446	29	31666865
Hyperglycaemia	15.24	15.05	8	30442	36468	31630426
Chest discomfort	15.18	15.05	15	30435	49354	31617540
Product physical consistency issue	15.07	15.05	8	30442	486	31666408

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	1962.22	12.61	1210	45174	146046	70736014
Drug withdrawal syndrome	1533.24	12.61	632	45752	32083	70849977
Drug dependence	1355.68	12.61	602	45782	36719	70845341
Application site pruritus	1123.61	12.61	293	46091	3308	70878752
Product adhesion issue	992.34	12.61	247	46137	2277	70879783
Application site erythema	823.93	12.61	244	46140	4517	70877543
Intentional product misuse	710.53	12.61	511	45873	79084	70802976
Substance abuse	621.17	12.61	236	46148	9601	70872459
Application site rash	605.14	12.61	159	46225	1850	70880210
Miosis	555.25	12.61	241	46143	13860	70868200
Toxicity to various agents	552.33	12.61	934	45450	381238	70500822
Application site pain	486.00	12.61	160	46224	4242	70877818
Application site burn	476.80	12.61	110	46274	706	70881354
Inadequate analgesia	455.78	12.61	150	46234	3972	70878088
Application site vesicles	452.36	12.61	116	46268	1217	70880843
Drug use disorder	346.15	12.61	147	46237	8004	70874056
Respiratory depression	326.36	12.61	203	46181	24628	70857432
Withdrawal syndrome	303.27	12.61	194	46190	24710	70857350
Alcohol abuse	295.46	12.61	115	46269	4992	70877068
Overdose	294.92	12.61	452	45932	169293	70712767
Somnolence	240.48	12.61	472	45912	215134	70666926
Coma	235.18	12.61	295	46089	91549	70790511
Application site irritation	199.69	12.61	64	46320	1553	70880507
Accidental overdose	183.54	12.61	165	46219	34956	70847104
Intentional product use issue	181.05	12.61	300	46084	119842	70762218
Application site scar	179.02	12.61	38	46346	155	70881905
Application site dryness	168.22	12.61	36	46348	154	70881906
Accidental exposure to product by child	158.12	12.61	62	46322	2744	70879316
Application site discolouration	142.40	12.61	41	46343	683	70881377
Asphyxia	142.07	12.61	87	46297	10255	70871805
Drug screen positive	140.38	12.61	71	46313	5769	70876291
Application site discharge	135.37	12.61	33	46351	276	70881784
Wrong technique in product usage process	130.58	12.61	191	46193	68507	70813553
Application site exfoliation	128.94	12.61	33	46351	343	70881717
Death	127.19	12.61	663	45721	509398	70372662
Application site urticaria	116.86	12.61	28	46356	216	70881844
Agitation	113.18	12.61	212	46172	93163	70788897
Application site erosion	108.69	12.61	26	46358	199	70881861
Injection site abscess	107.02	12.61	39	46345	1407	70880653
Hyperhidrosis	97.67	12.61	245	46139	131341	70750719
Injection site ulcer	96.76	12.61	30	46354	651	70881409
Accidental poisoning	95.77	12.61	37	46347	1573	70880487
Drug detoxification	95.74	12.61	25	46359	283	70881777
Rheumatoid arthritis	95.04	12.61	36	46348	291769	70590291
Injection site pain	90.45	12.61	222	46162	117397	70764663
Aggression	89.60	12.61	133	46251	48313	70833747
Injection site infection	88.64	12.61	37	46347	1927	70880133
Brain oedema	86.55	12.61	91	46293	23327	70858733
Pyrexia	84.19	12.61	169	46215	606783	70275277
Brachial artery entrapment syndrome	82.33	12.61	13	46371	0	70882060
Infusion related reaction	79.90	12.61	16	46368	197518	70684542
Logorrhoea	78.88	12.61	43	46341	4071	70877989
Febrile neutropenia	77.70	12.61	19	46365	204299	70677761
Application site swelling	76.11	12.61	25	46359	657	70881403
Arthropathy	75.46	12.61	6	46378	150051	70732009
Endocarditis staphylococcal	75.37	12.61	25	46359	678	70881382
Bradypnoea	75.17	12.61	46	46338	5413	70876647
Product physical issue	71.71	12.61	39	46345	3675	70878385
Application site reaction	70.73	12.61	24	46360	699	70881361
Disturbance in attention	69.81	12.61	111	46273	42783	70839277
Drug delivery system removal	69.67	12.61	11	46373	0	70882060
Hallucination	69.63	12.61	154	46230	76106	70805954
Drug diversion	69.19	12.61	27	46357	1179	70880881
Inappropriate schedule of product administration	68.31	12.61	189	46195	107366	70774694
Diarrhoea	68.07	12.61	273	46111	783068	70098992
Blepharospasm	67.72	12.61	38	46346	3807	70878253
Skin irritation	67.00	12.61	54	46330	9855	70872205
Hyperaesthesia	66.40	12.61	56	46328	10886	70871174
Synovitis	65.44	12.61	5	46379	129223	70752837
Euphoric mood	65.40	12.61	46	46338	6843	70875217
Application site scab	65.14	12.61	17	46367	192	70881868
Drug withdrawal syndrome neonatal	64.65	12.61	18	46366	264	70881796
Drug interaction	64.20	12.61	448	45936	380993	70501067
Depressed level of consciousness	62.97	12.61	161	46223	87270	70794790
Joint swelling	62.12	12.61	45	46339	253166	70628894
Maternal exposure during pregnancy	62.03	12.61	191	46193	115154	70766906
Stress cardiomyopathy	60.93	12.61	51	46333	9811	70872249
Taste disorder	60.46	12.61	54	46330	11331	70870729
Respiratory arrest	59.85	12.61	118	46266	53815	70828245
Hepatitis C	58.80	12.61	56	46328	12751	70869309
Product solubility abnormal	58.76	12.61	22	46362	857	70881203
Product administered at inappropriate site	58.47	12.61	33	46351	3343	70878717
Cluster headache	57.67	12.61	22	46362	903	70881157
Disorientation	57.48	12.61	121	46263	57802	70824258
Application site haemorrhage	57.24	12.61	24	46360	1264	70880796
Intentional underdose	57.19	12.61	28	46356	2121	70879939
Suicidal ideation	56.30	12.61	134	46250	69462	70812598
Treatment failure	55.58	12.61	13	46371	144129	70737931
Poisoning	55.19	12.61	71	46313	22551	70859509
Arthralgia	54.07	12.61	160	46224	503230	70378830
Application site ulcer	53.09	12.61	13	46371	111	70881949
Drug abuser	53.00	12.61	38	46346	5826	70876234
Platelet count decreased	51.63	12.61	26	46358	178196	70703864
Cough	50.89	12.61	84	46300	325293	70556767
Intentional removal of drug delivery system by patient	50.67	12.61	8	46376	0	70882060
Dysarthria	50.42	12.61	120	46264	62193	70819867
Substance dependence	50.37	12.61	17	46367	487	70881573
Pulmonary oedema	49.69	12.61	142	46242	82136	70799924
Fatigue	49.60	12.61	326	46058	823993	70058067
Injection site necrosis	49.49	12.61	22	46362	1337	70880723
Sarcopenia	49.20	12.61	16	46368	407	70881653
White blood cell count decreased	49.02	12.61	25	46359	170116	70711944
Therapeutic product effect increased	48.99	12.61	22	46362	1370	70880690
Systemic lupus erythematosus	48.73	12.61	5	46379	101897	70780163
Sinusitis	48.54	12.61	25	46359	169170	70712890
Restlessness	47.74	12.61	93	46291	42035	70840025
Unresponsive to stimuli	47.54	12.61	105	46279	51826	70830234
Neutropenia	47.50	12.61	59	46325	257097	70624963
Compartment syndrome	47.41	12.61	32	46352	4454	70877606
Dermo-hypodermitis	46.89	12.61	17	46367	604	70881456
Drug screen negative	46.13	12.61	14	46370	282	70881778
Application site odour	44.79	12.61	9	46375	26	70882034
Infection	43.69	12.61	44	46340	210741	70671319
Injection site extravasation	43.53	12.61	40	46344	8706	70873354
Injection site erosion	42.41	12.61	11	46373	121	70881939
Product dose omission issue	42.18	12.61	48	46336	217420	70664640
Myelopathy	41.79	12.61	29	46355	4222	70877838
Haemoglobin decreased	41.20	12.61	44	46340	205115	70676945
Breakthrough pain	41.02	12.61	19	46365	1271	70880789
Endocarditis	40.98	12.61	41	46343	9913	70872147
Incorrect route of product administration	40.97	12.61	67	46317	26425	70855635
Pneumonia	40.95	12.61	226	46158	596006	70286054
Decreased gait velocity	39.98	12.61	11	46373	154	70881906
Application site inflammation	39.92	12.61	14	46370	451	70881609
Impaired reasoning	39.69	12.61	10	46374	97	70881963
Quadriparesis	39.60	12.61	25	46359	3108	70878952
Glossodynia	39.46	12.61	5	46379	86482	70795578
Defaecation disorder	39.41	12.61	15	46369	612	70881448
Bradycardia foetal	38.98	12.61	10	46374	105	70881955
Subchondral insufficiency fracture	38.97	12.61	9	46375	58	70882002
Application site dermatitis	38.73	12.61	11	46373	174	70881886
Impaired driving ability	38.32	12.61	29	46355	4828	70877232
Product physical consistency issue	38.03	12.61	15	46369	674	70881386
17 ketosteroids urine abnormal	38.00	12.61	6	46378	0	70882060
Congenital multiplex arthrogryposis	37.73	12.61	7	46377	11	70882049
Yawning	37.71	12.61	18	46366	1289	70880771
Swelling	37.23	12.61	41	46343	188498	70693562
Delirium	36.84	12.61	120	46264	74494	70807566
Confusional state	36.61	12.61	314	46070	284084	70597976
Hypertension	36.33	12.61	88	46296	295945	70586115
Deafness neurosensory	36.30	12.61	32	46352	6600	70875460
Alopecia	36.16	12.61	46	46338	198444	70683616
Interstitial lung disease	35.60	12.61	12	46372	104673	70777387
Bradyphrenia	35.59	12.61	38	46346	9908	70872152
Aptyalism	33.56	12.61	14	46370	728	70881332
Application site pustules	32.70	12.61	7	46377	30	70882030
Exposure during pregnancy	32.15	12.61	128	46256	87589	70794471
Product substitution issue	31.63	12.61	49	46335	18464	70863596
Injection site cellulitis	31.62	12.61	17	46367	1565	70880495
Altered state of consciousness	31.22	12.61	76	46308	39946	70842114
Vestibular ischaemia	30.78	12.61	6	46378	14	70882046
Rash	30.56	12.61	202	46182	510360	70371700
Herpes zoster	30.35	12.61	9	46375	85226	70796834
Dyspnoea	29.93	12.61	341	46043	769719	70112341
Weight increased	29.75	12.61	72	46312	242259	70639801
Nasopharyngitis	29.73	12.61	63	46321	222143	70659917
Application site hypersensitivity	29.71	12.61	10	46374	284	70881776
Gastrointestinal disorder	29.60	12.61	16	46368	105411	70776649
Thrombocytopenia	29.39	12.61	71	46313	239039	70643021
Dermatitis contact	29.30	12.61	34	46350	9715	70872345
Contraindicated product administered	29.16	12.61	27	46357	134585	70747475
Suicide attempt	29.12	12.61	116	46268	79394	70802666
Injection site discharge	29.08	12.61	11	46373	441	70881619
Poisoning deliberate	28.93	12.61	45	46339	17015	70865045
Glomerulonephritis acute	28.78	12.61	9	46375	201	70881859
Product dispensing issue	28.63	12.61	8	46376	119	70881941
Housebound	28.62	12.61	11	46373	461	70881599
Mucosal inflammation	28.47	12.61	5	46379	67845	70814215
Ear deformity acquired	28.20	12.61	5	46379	5	70882055
Off label use	28.10	12.61	331	46053	742729	70139331
Disease progression	27.82	12.61	37	46347	156635	70725425
Product packaging quantity issue	27.78	12.61	14	46370	1128	70880932
Psoriasis	27.55	12.61	15	46369	98418	70783642
Substance use	27.17	12.61	12	46372	718	70881342
Congestive hepatopathy	27.11	12.61	22	46362	4052	70878008
Paranoia	27.11	12.61	44	46340	17244	70864816
COVID-19	26.96	12.61	18	46366	105739	70776321
Hypersensitivity	26.87	12.61	70	46314	229742	70652318
Sedation	26.62	12.61	79	46305	46652	70835408
Eyelid retraction	26.35	12.61	6	46378	36	70882024
Cardiac failure congestive	26.14	12.61	30	46354	135427	70746633
Hepatic enzyme increased	25.96	12.61	39	46345	156951	70725109
Faecaloma	25.80	12.61	33	46351	10418	70871642
Accidental death	25.79	12.61	21	46363	3887	70878173
Feeling drunk	25.78	12.61	22	46362	4345	70877715
Aspartate aminotransferase increased	25.74	12.61	27	46357	126951	70755109
Echocardiogram abnormal	25.53	12.61	16	46368	1963	70880097
Epilepsy	25.44	12.61	69	46315	38715	70843345
Hallucination, visual	25.37	12.61	58	46326	29279	70852781
Cerebrovascular accident	25.35	12.61	34	46350	143436	70738624
Anaemia	24.94	12.61	158	46226	403265	70478795
Micrognathia	24.27	12.61	5	46379	17	70882043
Psychomotor skills impaired	24.11	12.61	21	46363	4263	70877797
Troponin T increased	24.02	12.61	17	46367	2553	70879507
Prescription drug used without a prescription	23.88	12.61	18	46366	2979	70879081
Vomiting	23.88	12.61	531	45853	592580	70289480
Application site papules	23.74	12.61	6	46378	59	70882001
Chronic actinic dermatitis	23.44	12.61	5	46379	21	70882039
Tachyphrenia	23.24	12.61	15	46369	1936	70880124
Congenital coronary artery malformation	23.13	12.61	6	46378	66	70881994
Application site induration	23.10	12.61	4	46380	3	70882057
Vulvar basal cell carcinoma	22.72	12.61	5	46379	25	70882035
Blood cholesterol increased	22.68	12.61	7	46377	64597	70817463
Accidental exposure to product	22.66	12.61	54	46330	27997	70854063
Bronchitis	22.58	12.61	26	46358	117217	70764843
Musculoskeletal stiffness	22.28	12.61	39	46345	147721	70734339
Premature delivery	21.70	12.61	45	46339	21259	70860801
Maternal use of illicit drugs	21.67	12.61	4	46380	6	70882054
Atrial fibrillation	21.66	12.61	56	46328	184292	70697768
Victim of sexual abuse	21.65	12.61	9	46375	464	70881596
Neutrophil count decreased	21.60	12.61	14	46370	83542	70798518
Hypoventilation	21.55	12.61	24	46360	6558	70875502
Neuropathy peripheral	21.49	12.61	31	46353	126865	70755195
Cataract	21.48	12.61	5	46379	55640	70826420
Cyanosis	21.32	12.61	47	46337	23159	70858901
Product preparation error	21.27	12.61	20	46364	4482	70877578
Therapy non-responder	21.12	12.61	12	46372	76903	70805157
Abnormal behaviour	21.04	12.61	60	46324	34649	70847411
Pleural effusion	21.02	12.61	34	46350	132830	70749230
Blood glucose increased	20.75	12.61	22	46362	102960	70779100
Pain in extremity	20.52	12.61	128	46256	327954	70554106
Emotional poverty	20.52	12.61	10	46374	750	70881310
Dementia with Lewy bodies	20.50	12.61	10	46374	751	70881309
Asthenia	20.44	12.61	196	46188	457470	70424590
Respiratory rate decreased	20.24	12.61	20	46364	4762	70877298
Coronary artery disease	19.96	12.61	8	46376	62728	70819332
Mydriasis	19.95	12.61	37	46347	16116	70865944
Nasal congestion	19.89	12.61	9	46375	65663	70816397
Venous thrombosis	19.66	12.61	23	46361	6626	70875434
Injection site inflammation	19.64	12.61	17	46367	3421	70878639
Neurosis	19.59	12.61	8	46376	394	70881666
Psoriatic arthropathy	19.43	12.61	9	46375	64762	70817298
Application site bruise	19.35	12.61	7	46377	247	70881813
Abortion spontaneous	19.30	12.61	49	46335	26430	70855630
Oral administration complication	19.27	12.61	6	46378	132	70881928
Electrocardiogram T wave alternans	19.20	12.61	5	46379	56	70882004
Type 2 diabetes mellitus	19.05	12.61	3	46381	44077	70837983
Influenza	19.03	12.61	28	46356	113672	70768388
Pupil constriction procedure	19.00	12.61	3	46381	0	70882060
Foetal non-stress test abnormal	19.00	12.61	3	46381	0	70882060
Injection site erythema	18.88	12.61	96	46288	72828	70809232
Irritable bowel syndrome	18.79	12.61	5	46379	50845	70831215
Intervertebral discitis	18.73	12.61	18	46366	4143	70877917
Haematocrit decreased	18.72	12.61	7	46377	57251	70824809
Lack of application site rotation	18.71	12.61	4	46380	17	70882043
Substance use disorder	18.69	12.61	9	46375	657	70881403
Vestibular disorder	18.63	12.61	14	46370	2306	70879754
Brief psychotic disorder with marked stressors	18.50	12.61	7	46377	281	70881779
Radial nerve palsy	18.38	12.61	8	46376	462	70881598
Injection site ischaemia	18.35	12.61	4	46380	19	70882041
Therapy naive	18.31	12.61	5	46379	68	70881992
Substance abuser	18.22	12.61	6	46378	159	70881901
Application site perspiration	18.18	12.61	4	46380	20	70882040
Urticaria	18.05	12.61	51	46333	162998	70719062
Incoherent	17.93	12.61	23	46361	7283	70874777
Abdominal discomfort	17.79	12.61	76	46308	214582	70667478
Mastication disorder	17.74	12.61	14	46370	2478	70879582
Chest discomfort	17.71	12.61	34	46350	124347	70757713
Constipation	17.68	12.61	247	46137	252191	70629869
Apnoea	17.62	12.61	28	46356	10781	70871279
Persistent depressive disorder	17.55	12.61	10	46374	1031	70881029
Stomatitis	17.55	12.61	36	46348	128475	70753585
Foetal exposure during pregnancy	17.49	12.61	20	46364	5625	70876435
Application site infection	17.38	12.61	5	46379	83	70881977
Allodynia	17.32	12.61	11	46373	1382	70880678
Cardio-respiratory arrest	17.31	12.61	119	46265	100558	70781502
Wrong dose	17.19	12.61	11	46373	1400	70880660
Upper respiratory tract infection	17.05	12.61	16	46368	79258	70802802
Judgement impaired	17.01	12.61	10	46374	1094	70880966
Loss of consciousness	17.00	12.61	166	46218	155550	70726510
Administration site abscess sterile	16.92	12.61	3	46381	3	70882057
Pancytopenia	16.92	12.61	47	46337	151060	70731000
Reaction to excipient	16.86	12.61	11	46373	1447	70880613
Memory impairment	16.82	12.61	111	46273	92530	70789530
Hypertonia	16.81	12.61	21	46363	6477	70875583
Haemorrhage	16.78	12.61	18	46366	83797	70798263
Pulmonary congestion	16.75	12.61	45	46339	25109	70856951
Malignant neoplasm progression	16.71	12.61	34	46350	121705	70760355
Cryoglobulinaemia	16.69	12.61	9	46375	834	70881226
Tooth hypoplasia	16.61	12.61	6	46378	211	70881849
Chronic hepatitis C	16.45	12.61	8	46376	597	70881463
Injection site oedema	16.44	12.61	10	46374	1164	70880896
Anxiety	16.42	12.61	218	46166	220112	70661948
Rhabdomyolysis	16.35	12.61	113	46271	95647	70786413
Hyperkalaemia	16.19	12.61	28	46356	106563	70775497
Pneumonia aspiration	16.12	12.61	82	46302	62207	70819853
Diabetes mellitus	16.04	12.61	14	46370	71810	70810250
Product odour abnormal	16.00	12.61	10	46374	1221	70880839
Clostridium difficile infection	15.98	12.61	3	46381	38813	70843247
Oropharyngeal pain	15.84	12.61	24	46360	96286	70785774
Ill-defined disorder	15.82	12.61	8	46376	54733	70827327
Faeces soft	15.78	12.61	21	46363	6889	70875171
Dysphoria	15.77	12.61	17	46367	4481	70877579
Victim of crime	15.63	12.61	7	46377	433	70881627
Hallucinations, mixed	15.57	12.61	20	46364	6342	70875718
Dyspnoea exertional	15.53	12.61	17	46367	78413	70803647
Plasma cell myeloma	15.48	12.61	15	46369	73186	70808874
Genitourinary symptom	15.38	12.61	6	46378	262	70881798
Alcohol interaction	15.29	12.61	17	46367	4636	70877424
Cerebral vasoconstriction	15.22	12.61	10	46374	1330	70880730
Cystic lymphangioma	14.85	12.61	3	46381	9	70882051
Repetitive strain injury	14.72	12.61	5	46379	146	70881914
Myocardial infarction	14.70	12.61	60	46324	171585	70710475
Bruxism	14.69	12.61	15	46369	3714	70878346
Epistaxis	14.65	12.61	28	46356	102599	70779461
Cardiogenic shock	14.54	12.61	3	46381	36304	70845756
Delusion	14.52	12.61	36	46348	19129	70862931
Urinary incontinence	14.49	12.61	56	46328	37786	70844274
Dependence	14.43	12.61	12	46372	2288	70879772
Product contamination	14.29	12.61	9	46375	1114	70880946
Testicular pain	14.28	12.61	11	46373	1880	70880180
Blood creatinine increased	14.20	12.61	47	46337	142954	70739106
Ankyloglossia congenital	14.18	12.61	3	46381	12	70882048
Adjacent segment degeneration	14.18	12.61	3	46381	12	70882048
Lactic acidosis	14.13	12.61	13	46371	65011	70817049
Drug hypersensitivity	14.12	12.61	107	46277	262352	70619708
Embolia cutis medicamentosa	14.07	12.61	7	46377	549	70881511
Persecutory delusion	13.99	12.61	16	46368	4501	70877559
Throat irritation	13.97	12.61	3	46381	35301	70846759
Injection site irritation	13.93	12.61	14	46370	3401	70878659
Hypopnoea	13.93	12.61	14	46370	3401	70878659
Dermal absorption impaired	13.81	12.61	3	46381	14	70882046
Psychotic disorder	13.80	12.61	55	46329	37646	70844414
Incorrect product administration duration	13.63	12.61	25	46359	10799	70871261
Drug intolerance	13.61	12.61	89	46295	225598	70656462
Mental disorder	13.55	12.61	45	46339	28195	70853865
Placental disorder	13.55	12.61	8	46376	882	70881178
Sepsis	13.49	12.61	99	46285	244446	70637614
Developmental hip dysplasia	13.42	12.61	5	46379	192	70881868
Productive cough	13.40	12.61	19	46365	78318	70803742
Maternal drugs affecting foetus	13.38	12.61	10	46374	1634	70880426
Drug reaction with eosinophilia and systemic symptoms	13.33	12.61	11	46373	58002	70824058
Discoloured vomit	13.08	12.61	9	46375	1292	70880768
Hyponatraemia	13.06	12.61	57	46327	160030	70722030
Hypotension	13.06	12.61	186	46198	404195	70477865
Muscle rigidity	13.06	12.61	34	46350	18616	70863444
Blood pressure decreased	13.04	12.61	25	46359	91490	70790570
Road traffic accident	13.02	12.61	51	46333	34631	70847429
Lividity	12.99	12.61	6	46378	399	70881661
Reversible cerebral vasoconstriction syndrome	12.82	12.61	12	46372	2673	70879387
Migraine	12.78	12.61	86	46298	72152	70809908
Tachycardia	12.70	12.61	159	46225	158387	70723673
Heart rate abnormal	12.67	12.61	17	46367	5622	70876438
Cachexia	12.63	12.61	23	46361	9877	70872183

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 INC	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 INC	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 INC	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 INC	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
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	TREATEMENT 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	TREATEMENT 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	TREATEMENT 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	TREATEMENT 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	TREATEMENT 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	TREATEMENT 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	TREATEMENT 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 INC	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	11135216	Aug. 7, 2029	TREATING OPIOID USE DISORDER
EQ 12MG BASE;EQ 3MG BASE	SUBOXONE	INDIVIOR INC	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 INC	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 INC	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 INC	N022410	Aug. 10, 2012	RX	FILM	BUCCAL, SUBLINGUAL	11135216	Aug. 7, 2029	TREATING OPIOID USE DISORDER
EQ 4MG BASE;EQ 1MG BASE	SUBOXONE	INDIVIOR INC	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 INC	N022410	Aug. 30, 2010	RX	FILM	BUCCAL, SUBLINGUAL	11135216	Aug. 7, 2029	TREATING OPIOID USE DISORDER
EQ 8MG BASE;EQ 2MG BASE	SUBOXONE	INDIVIOR INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	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 INC	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	8921387	Jan. 6, 2032	TREATING OPIOID DEPENDENCY BY ADMINISTERING BUPRENORPHINE ONCE PER MONTH
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 INC	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11000520	Nov. 6, 2035	TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR INC	N209819	Nov. 30, 2017	RX	SOLUTION, EXTENDED RELEASE	SUBCUTANEOUS	11000520	Nov. 6, 2035	TREATING OPIOID USE DISORDER
300MG/1.5ML (200MG/ML)	SUBLOCADE	INDIVIOR INC	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)

None

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
4018880	VANDF
4019644	VANDF
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
001573	NDDF
004632	NDDF
21066009	SNOMEDCT_US
31684002	SNOMEDCT_US
387173000	SNOMEDCT_US

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	0054-0177	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	0054-0189	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	0093-3656	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	0093-3658	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 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
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0228-3153	TABLET	8 mg	SUBLINGUAL	ANDA	32 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0228-3153	TABLET	8 mg	SUBLINGUAL	ANDA	32 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0228-3153	TABLET	8 mg	SUBLINGUAL	ANDA	32 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3154	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3154	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3154	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3155	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3155	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3155	TABLET	8 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0228-3156	TABLET	2 mg	SUBLINGUAL	ANDA	32 sections
Buprenorphine	HUMAN PRESCRIPTION DRUG LABEL	1	0228-3156	TABLET	2 mg	SUBLINGUAL	ANDA	32 sections