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

Stem definition	Drug id	CAS RN
opioid receptor antagonists/agonists related to normorphine	1878	465-65-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: naloxone hydrochloride dihydrate naloxone hydrochloride hydrate naloxone hydrobromide evzio naloxone l-naloxone (-)-Naloxone naloxone hydrochloride naloxone HCl	A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors. Molecular weight: 327.38 Formula: C19H21NO4 CLOGP: 0.16 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 70 ALOGS: -1.76 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

naloxone hydrochloride dihydrate
naloxone hydrochloride hydrate
naloxone hydrobromide
evzio
naloxone
l-naloxone
(-)-Naloxone
naloxone hydrochloride
naloxone HCl

A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.

Molecular weight: 327.38
Formula: C19H21NO4
CLOGP: 0.16
LIPINSKI: 0
HAC: 5
HDO: 2
TPSA: 70
ALOGS: -1.76
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
75	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.31 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	2 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.70 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	23 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.54 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.10 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Nov. 9, 2017	EMA	Mundipharma Corporation (Ireland) Limited
April 13, 1971	FDA	ADAPT

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
Exposure during pregnancy	225.06	15.25	188	9567	155359	63323908
Abortion spontaneous	136.75	15.25	87	9668	47108	63432159
Toxicity to various agents	134.36	15.25	177	9578	247073	63232194
Respiratory depression	133.23	15.25	57	9698	13658	63465609
Drug withdrawal syndrome neonatal	106.61	15.25	30	9725	2051	63477216
Overdose	105.54	15.25	108	9647	114970	63364297
Drug withdrawal syndrome	98.90	15.25	58	9697	27136	63452131
Selective abortion	74.10	15.25	14	9741	155	63479112
Premature delivery	71.12	15.25	49	9706	30232	63449035
Coma	63.69	15.25	63	9692	64301	63414966
Unresponsive to stimuli	61.79	15.25	47	9708	33769	63445498
Miosis	56.70	15.25	26	9729	7327	63471940
Depressed level of consciousness	56.36	15.25	58	9697	62020	63417247
Bradypnoea	56.23	15.25	21	9734	3529	63475738
Abortion induced	48.53	15.25	26	9729	10216	63469051
Thymus disorder	43.81	15.25	10	9745	291	63478976
Suicide attempt	43.22	15.25	50	9705	60868	63418399
Cardiac arrest	42.16	15.25	61	9694	92484	63386783
Intestinal infarction	39.88	15.25	12	9743	1038	63478229
Renal infarct	36.09	15.25	12	9743	1435	63477832
Bradycardia	35.91	15.25	50	9705	73177	63406090
Respiratory rate decreased	35.33	15.25	15	9740	3520	63475747
Maternal exposure during pregnancy	33.07	15.25	91	9664	219971	63259296
Electrocardiogram QT prolonged	32.76	15.25	43	9712	59487	63419780
Respiratory alkalosis	32.20	15.25	13	9742	2688	63476579
Apnoea	31.51	15.25	18	9737	8004	63471263
Somnolence	31.03	15.25	78	9677	178607	63300660
Mental status changes	28.92	15.25	33	9722	39566	63439701
Aplastic anaemia	28.57	15.25	18	9737	9551	63469716
Generalised anxiety disorder	28.28	15.25	11	9744	2063	63477204
Sinus tachycardia	28.25	15.25	26	9729	24242	63455025
Foetal exposure during pregnancy	27.44	15.25	29	9726	31933	63447334
Delirium	27.02	15.25	36	9719	50505	63428762
Alopecia	25.49	15.25	10	9745	337526	63141741
Encephalopathy	24.58	15.25	30	9725	38590	63440677
Hypotension	24.01	15.25	94	9661	272510	63206757
Rhesus incompatibility	23.94	15.25	5	9750	95	63479172
Tachyphylaxis	23.76	15.25	6	9749	270	63478997
Premature baby	23.72	15.25	22	9733	20713	63458554
Withdrawal syndrome	22.45	15.25	21	9734	19976	63459291
Substance abuse	22.20	15.25	12	9743	4795	63474472
Systemic lupus erythematosus	22.03	15.25	3	9752	208915	63270352
Drug interaction	21.81	15.25	81	9674	229050	63250217
Blood albumin decreased	21.56	15.25	18	9737	14748	63464519
Respiratory failure	21.50	15.25	48	9707	101810	63377457
Hypoaesthesia teeth	21.19	15.25	4	9751	44	63479223
Seizure	21.05	15.25	56	9699	132578	63346689
Drug intolerance	20.42	15.25	11	9744	308650	63170617
Sinusitis	20.17	15.25	5	9750	226648	63252619
Abdominal discomfort	19.04	15.25	13	9742	320872	63158395
Accidental exposure to product by child	18.68	15.25	7	9748	1186	63478081
Respiratory acidosis	18.48	15.25	12	9743	6703	63472564
Hepatic necrosis	17.74	15.25	11	9744	5676	63473591
Infusion related reaction	17.36	15.25	8	9747	245513	63233754
Joint swelling	17.25	15.25	15	9740	327651	63151616
Insulin resistance	16.91	15.25	6	9749	872	63478395
Rheumatoid arthritis	16.85	15.25	9	9746	253810	63225457
Cardiogenic shock	16.70	15.25	17	9738	17915	63461352
Impaired insulin secretion	16.25	15.25	3	9752	29	63479238
Metastatic gastric cancer	16.15	15.25	4	9751	166	63479101
Therapy naive	15.73	15.25	3	9752	35	63479232
Hyporesponsive to stimuli	15.57	15.25	6	9749	1098	63478169
Acne pustular	15.51	15.25	4	9751	196	63479071

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 withdrawal syndrome	160.19	16.41	81	7627	19753	34929470
Drug withdrawal syndrome neonatal	153.71	16.41	49	7659	3570	34945653
Overdose	133.69	16.41	130	7578	90929	34858294
Unresponsive to stimuli	100.11	16.41	67	7641	27502	34921721
Respiratory depression	90.85	16.41	52	7656	16193	34933030
Miosis	74.18	16.41	38	7670	9497	34939726
Toxicity to various agents	69.78	16.41	143	7565	200219	34749004
Non-cardiogenic pulmonary oedema	64.07	16.41	17	7691	644	34948579
Drug dependence	52.13	16.41	43	7665	24174	34925049
Foetal exposure during pregnancy	42.42	16.41	47	7661	38054	34911169
Maternal exposure during breast feeding	42.17	16.41	15	7693	1526	34947697
Drug abuse	38.30	16.41	74	7634	99022	34850201
Depressed level of consciousness	36.35	16.41	46	7662	42795	34906428
Cerebral congestion	34.48	16.41	6	7702	26	34949197
Cardiac arrest	33.77	16.41	69	7639	96090	34853133
Rhesus incompatibility	31.81	16.41	6	7702	44	34949179
Substance abuse	31.19	16.41	20	7688	7621	34941602
Bradypnoea	30.19	16.41	14	7694	2815	34946408
Drug ineffective	29.93	16.41	187	7521	456564	34492659
Delusion	28.36	16.41	23	7685	12612	34936611
Pulmonary oedema	28.25	16.41	43	7665	47486	34901737
Accidental exposure to product	28.10	16.41	23	7685	12779	34936444
Coma	26.69	16.41	41	7667	45637	34903586
Blood ethanol	26.19	16.41	6	7702	122	34949101
Therapy naive	26.01	16.41	5	7703	41	34949182
Jaundice neonatal	25.48	16.41	10	7698	1336	34947887
Paranoia	25.07	16.41	21	7687	12047	34937176
Breech presentation	24.64	16.41	6	7702	160	34949063
Accidental exposure to product by child	24.58	16.41	10	7698	1466	34947757
Brain oedema	24.56	16.41	22	7686	13799	34935424
Hallucination	24.35	16.41	42	7666	51456	34897767
Counterfeit product administered	24.32	16.41	6	7702	169	34949054
Lethargy	24.15	16.41	37	7671	41085	34908138
Postmortem blood drug level	23.50	16.41	6	7702	195	34949028
Hypopnoea	23.41	16.41	11	7697	2278	34946945
Amphetamines positive	22.93	16.41	6	7702	215	34949008
Brief psychotic disorder with marked stressors	22.67	16.41	6	7702	225	34948998
Agitation	22.31	16.41	43	7665	57356	34891867
Hypercapnia	22.12	16.41	13	7695	4242	34944981
Intentional product misuse	21.30	16.41	37	7671	45574	34903649
Compartment syndrome	20.53	16.41	11	7697	3007	34946216
Respiratory acidosis	20.07	16.41	13	7695	5037	34944186
Pancreatic disorder	19.72	16.41	9	7699	1745	34947478
Restrictive cardiomyopathy	19.71	16.41	7	7701	708	34948515
Axillary pain	19.67	16.41	6	7702	377	34948846
Accidental poisoning	19.03	16.41	7	7701	783	34948440
Somnolence	17.43	16.41	59	7649	111057	34838166
Aggression	17.40	16.41	31	7677	38933	34910290
Opiates positive	17.21	16.41	6	7702	575	34948648
Spinal disorder	17.03	16.41	11	7697	4241	34944982
Road traffic accident	16.83	16.41	20	7688	17430	34931793
Grimacing	16.81	16.41	5	7703	288	34948935
Withdrawal syndrome	16.75	16.41	17	7691	12438	34936785
Acute on chronic liver failure	16.63	16.41	4	7704	101	34949122
Pupil fixed	16.43	16.41	8	7700	1793	34947430

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
Respiratory depression	217.66	14.58	103	13792	27527	79702966
Overdose	199.03	14.58	200	13695	184006	79546487
Drug withdrawal syndrome	184.08	14.58	99	13796	34619	79695874
Toxicity to various agents	183.40	14.58	290	13605	421250	79309243
Unresponsive to stimuli	140.77	14.58	99	13796	55689	79674804
Miosis	134.02	14.58	62	13833	15727	79714766
Coma	91.87	14.58	100	13795	100549	79629944
Bradypnoea	88.68	14.58	35	13860	6017	79724476
Depressed level of consciousness	84.69	14.58	94	13801	96558	79633935
Cardiac arrest	73.92	14.58	118	13777	171978	79558515
Non-cardiogenic pulmonary oedema	67.04	14.58	20	13875	1479	79729014
Drug ineffective	59.38	14.58	355	13540	1080558	78649935
Pulmonary oedema	51.58	14.58	70	13825	88184	79642309
Somnolence	47.81	14.58	119	13776	238862	79491631
Bradycardia	45.06	14.58	83	13812	135474	79595019
Drug abuse	44.80	14.58	92	13803	162599	79567894
Drug dependence	43.39	14.58	44	13851	40725	79689768
Accidental exposure to product by child	43.14	14.58	17	13878	2909	79727584
Thymus disorder	42.69	14.58	10	13885	287	79730206
Suicide attempt	39.94	14.58	60	13835	82872	79647621
Respiratory acidosis	38.20	14.58	24	13871	11176	79719317
Respiratory rate decreased	36.58	14.58	18	13877	5225	79725268
Mental status changes	35.95	14.58	51	13844	66908	79663585
Brain oedema	35.91	14.58	32	13863	25231	79705262
Intestinal infarction	35.55	14.58	12	13883	1324	79729169
Hypotension	34.57	14.58	160	13735	440157	79290336
Lethargy	33.84	14.58	55	13840	81237	79649256
Accidental exposure to product	33.68	14.58	34	13861	31288	79699205
Aplastic anaemia	32.27	14.58	26	13869	17879	79712614
Exposure during pregnancy	31.20	14.58	60	13835	101072	79629421
Sinus tachycardia	30.76	14.58	35	13860	36873	79693620
Generalised anxiety disorder	29.73	14.58	12	13883	2185	79728308
Substance abuse	29.63	14.58	20	13875	10506	79719987
Apnoea	27.71	14.58	20	13875	11684	79718809
Renal infarct	27.38	14.58	12	13883	2679	79727814
Respiratory failure	27.05	14.58	81	13814	180830	79549663
Abortion spontaneous	26.33	14.58	29	13866	29478	79701015
Accidental overdose	25.58	14.58	33	13862	39548	79690945
Cerebral congestion	25.54	14.58	5	13890	59	79730434
Blood ethanol	25.39	14.58	6	13889	179	79730314
Withdrawal syndrome	25.02	14.58	27	13868	26827	79703666
Electrocardiogram QT prolonged	24.72	14.58	51	13844	90335	79640158
Compartment syndrome	22.82	14.58	13	13882	5069	79725424
Hypoxic-ischaemic encephalopathy	22.35	14.58	15	13880	7805	79722688
Brief psychotic disorder with marked stressors	22.34	14.58	6	13889	303	79730190
Hypoxia	22.30	14.58	53	13842	103190	79627303
Accidental poisoning	22.25	14.58	9	13886	1648	79728845
Respiratory alkalosis	22.01	14.58	12	13883	4299	79726194
Amphetamines positive	21.73	14.58	6	13889	336	79730157
Delusion	21.65	14.58	22	13873	20401	79710092
Postmortem blood drug level	21.63	14.58	6	13889	342	79730151
Rheumatoid arthritis	21.45	14.58	5	13890	208465	79522028
Agitation	21.33	14.58	51	13844	99664	79630829
Hypoaesthesia teeth	20.95	14.58	4	13891	41	79730452
Stress cardiomyopathy	19.67	14.58	16	13879	11150	79719343
Restrictive cardiomyopathy	18.97	14.58	7	13888	1001	79729492
Paranoia	18.92	14.58	20	13875	19412	79711081
Delirium	18.88	14.58	44	13851	84583	79645910
Joint swelling	18.44	14.58	14	13881	288632	79441861
Hypercapnia	18.31	14.58	14	13881	8921	79721572
Sickle cell anaemia with crisis	17.54	14.58	13	13882	7909	79722584
Hypopnoea	17.13	14.58	11	13884	5318	79725175
Acute respiratory failure	16.75	14.58	34	13861	59507	79670986
Rash	16.54	14.58	49	13846	578309	79152184
Respiratory arrest	16.36	14.58	33	13862	57517	79672976
Abdominal discomfort	16.22	14.58	12	13883	250715	79479778
Pancreatic disorder	16.08	14.58	9	13886	3393	79727100
Pupil fixed	15.68	14.58	9	13886	3557	79726936
Appetite disorder	15.58	14.58	12	13883	7727	79722766
Delayed recovery from anaesthesia	15.54	14.58	7	13888	1666	79728827
Intentional overdose	15.41	14.58	47	13848	105913	79624580
Drug intolerance	15.40	14.58	14	13881	264105	79466388
Opiates positive	15.39	14.58	6	13889	998	79729495
Alopecia	15.06	14.58	11	13884	231344	79499149
Seizure	15.05	14.58	69	13826	188765	79541728
Impaired insulin secretion	14.72	14.58	3	13892	44	79730449

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A06AH04	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Peripheral opioid receptor antagonists
ATC	N02AA53	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AA55	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AX51	NERVOUS SYSTEM ANALGESICS OPIOIDS Other opioids
ATC	V03AB15	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Antidotes
FDA MoA	N0000000154	Opioid Antagonists
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D009292	Narcotic Antagonists
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D018689	Sensory System Agents
CHEBI has role	CHEBI:35488	central nervous system depressants
CHEBI has role	CHEBI:50137	mu-opioid receptor antagonists
CHEBI has role	CHEBI:90755	antidote to opioid overdose
FDA EPC	N0000175691	Opioid Antagonist

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

Disease	Relation	SNOMED_ID	DOID
Pain	indication	22253000
Opioid dependence	indication	75544000	DOID:2559
Poisoning by opiate analgesic drug	indication	241749009
Overdose of opiate	indication	242253008
Prevention of opioid abuse	indication	426928008
Opiate-Induced Respiratory Depression	indication
Suicidal thoughts	contraindication	6471006
Dependent drug abuse	contraindication	6525002
Alcohol withdrawal delirium	contraindication	8635005
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Asthenia	contraindication	13791008
Constipation	contraindication	14760008	DOID:2089
Chronic disease of respiratory system	contraindication	17097001
Mood swings	contraindication	18963009
Inflammatory bowel disease	contraindication	24526004	DOID:0050589
Alcohol intoxication	contraindication	25702006
Shock	contraindication	27942005
Orthostatic hypotension	contraindication	28651003
Hypercapnia	contraindication	29596007
Torsades de pointes	contraindication	31722008
Dehydration	contraindication	34095006
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Hypothyroidism	contraindication	40930008	DOID:1459
Conduction disorder of the heart	contraindication	44808001
Low blood pressure	contraindication	45007003
Bradycardia	contraindication	48867003
Paralytic ileus	contraindication	55525008	DOID:8442
Chronic type B viral hepatitis	contraindication	61977001
Ulcerative colitis	contraindication	64766004	DOID:8577
Substance abuse	contraindication	66214007
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
Opioid withdrawal	contraindication	87132004
Pulmonary emphysema	contraindication	87433001
Kidney disease	contraindication	90708001	DOID:557
Disorder of biliary tract	contraindication	105997008	DOID:9741
Prolonged QT interval	contraindication	111975006
Acute abdominal pain	contraindication	116290004
Neoplasm of brain	contraindication	126952004	DOID:1319
Chronic hepatitis C	contraindication	128302006
Seizure disorder	contraindication	128613002
Liver function tests abnormal	contraindication	166603001
Drug-induced psychosis	contraindication	191483003	DOID:1742
Disease of liver	contraindication	235856003	DOID:409
Morbid obesity	contraindication	238136002	DOID:11981
Benign prostatic hyperplasia	contraindication	266569009
Retention of urine	contraindication	267064002
Exacerbation of asthma	contraindication	281239006
Lesion of brain	contraindication	301766008
Coma	contraindication	371632003
Primary adrenocortical insufficiency	contraindication	373662000
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Operation on gastrointestinal tract	contraindication	386621005
Hypoxia	contraindication	389086002
Respiratory insufficiency	contraindication	409623005
Central nervous system depression	contraindication	418072004
Dysfunction of sphincter of Oddi	contraindication	430887001
Congenital long QT syndrome	contraindication	442917000
Kyphoscoliosis with Respiratory Compromise	contraindication
Pain in Opioid Naive Patients	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.31	acidic
pKa2	7.47	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
10MG;20MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9555000	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9907793	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9555000	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
5MG;10MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9907793	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
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
0.4MG/0.4ML (0.4MG/0.4ML)	EVZIO	KALEO INC	N205787	April 3, 2014	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	9724471	May 23, 2027	METHOD FOR CONFIRMING DOSE DELIVERY
2MG/0.4ML (2MG/0.4ML)	EVZIO (AUTOINJECTOR)	KALEO INC	N209862	Oct. 19, 2016	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	9724471	May 23, 2027	METHOD FOR CONFIRMING DOSE DELIVERY
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 0.7MG 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
0.4MG/0.4ML (0.4MG/0.4ML)	EVZIO	KALEO INC	N205787	April 3, 2014	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	10322239	Feb. 28, 2031	USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
0.4MG/0.4ML (0.4MG/0.4ML)	EVZIO	KALEO INC	N205787	April 3, 2014	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	9474869	Feb. 28, 2031	USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
2MG/0.4ML (2MG/0.4ML)	EVZIO (AUTOINJECTOR)	KALEO INC	N209862	Oct. 19, 2016	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	10322239	Feb. 28, 2031	USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
2MG/0.4ML (2MG/0.4ML)	EVZIO (AUTOINJECTOR)	KALEO INC	N209862	Oct. 19, 2016	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	9474869	Feb. 28, 2031	USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
10MG/0.4ML (10MG/0.4ML)	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	KALEO INC	N215457	Feb. 28, 2022	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	10322239	Feb. 28, 2031	USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
10MG/0.4ML (10MG/0.4ML)	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	KALEO INC	N215457	Feb. 28, 2022	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	9474869	Feb. 28, 2031	USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE
0.4MG/0.4ML (0.4MG/0.4ML)	EVZIO	KALEO INC	N205787	April 3, 2014	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	10143972	May 24, 2031	USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
2MG/0.4ML (2MG/0.4ML)	EVZIO (AUTOINJECTOR)	KALEO INC	N209862	Oct. 19, 2016	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	10143792	May 24, 2031	USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
10MG/0.4ML (10MG/0.4ML)	NALOXONE HYDROCHLORIDE (AUTOINJECTOR)	KALEO INC	N215457	Feb. 28, 2022	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	10143792	May 24, 2031	USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
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
0.4MG/0.4ML (0.4MG/0.4ML)	EVZIO	KALEO INC	N205787	April 3, 2014	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	9517307	July 18, 2034	USE OF AN AUTO INJECTOR TO ADMINISTER NALOXONE HCL
2MG/0.4ML (2MG/0.4ML)	EVZIO (AUTOINJECTOR)	KALEO INC	N209862	Oct. 19, 2016	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	9517307	July 18, 2034	USE OF AN AUTO INJECTOR TO ADMINISTER NALOXONE HCL
8MG/SPRAY	KLOXXADO	HIKMA	N212045	April 29, 2021	RX	SPRAY	NASAL	10722510	Aug. 26, 2034	USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
8MG/SPRAY	KLOXXADO	HIKMA	N212045	April 29, 2021	RX	SPRAY	NASAL	10973814	Aug. 26, 2034	USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
8MG/SPRAY	KLOXXADO	HIKMA	N212045	April 29, 2021	RX	SPRAY	NASAL	11617713	Aug. 26, 2034	USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
8MG/SPRAY	KLOXXADO	HIKMA	N212045	April 29, 2021	RX	SPRAY	NASAL	11628139	Aug. 26, 2034	USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS
2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NARCAN	EMERGENT	N208411	Jan. 24, 2017	DISCN	SPRAY, METERED	NASAL	9480644	March 16, 2035	USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	NARCAN	EMERGENT	N208411	Jan. 24, 2017	DISCN	SPRAY, METERED	NASAL	9707226	March 16, 2035	USE OF NALOXONE HYDROCHLORIDE FOR EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION.
0.4MG/0.4ML (0.4MG/0.4ML)	EVZIO	KALEO INC	N205787	April 3, 2014	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	10220158	March 20, 2035	USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE
2MG/0.4ML (2MG/0.4ML)	EVZIO (AUTOINJECTOR)	KALEO INC	N209862	Oct. 19, 2016	DISCN	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	10220158	March 20, 2035	USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE
5MG/0.5ML (5MG/0.5ML)	ZIMHI	ADAMIS PHARMS CORP	N212854	Oct. 15, 2021	RX	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	11571518	June 14, 2041	A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF AN OPIOID ANTAGONIST COMPRISING AN EMERGENCY SYRINGE DEVICE
5MG/0.5ML (5MG/0.5ML)	ZIMHI	ADAMIS PHARMS CORP	N212854	Oct. 15, 2021	RX	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	11571518	June 14, 2041	A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF AN OPIOID ANTAGONIST COMPRISING AN EMERGENCY SYRINGE DEVICE INCLUDING A NEEDLE GUARD
5MG/0.5ML (5MG/0.5ML)	ZIMHI	ADAMIS PHARMS CORP	N212854	Oct. 15, 2021	RX	SOLUTION	INTRAMUSCULAR, SUBCUTANEOUS	11571518	June 14, 2041	A METHOD FOR ADMINISTERING A THERAPEUTIC DOSE OF AN OPIOID ANTAGONIST COMPRISING AN EMERGENCY SYRINGE DEVICE INCLUDING A WINDOW CONFIGURED TO ALLOW THE USER TO VIEW THE OPIOID ANTAGONIST IN THE SYRINGE

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
4MG/SPRAY	REXTOVY	AMPHASTAR PHARMS INC	N208969	March 7, 2023	RX	SPRAY, METERED	NASAL	March 7, 2026	NEW PRODUCT

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	ANTAGONIST	Ki	8.81	WOMBAT-PK	CHEMBL
Cytochrome P450 2D6	Enzyme	P10635	CP2D6_HUMAN		IC50	5.70	DRUG MATRIX
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN		IC50	8.80	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN	ANTAGONIST	Ki	8.50	WOMBAT-PK
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN	ANTAGONIST	Ki	7.27	WOMBAT-PK
Mu-type opioid receptor	GPCR		OPRM_RAT		Kd	9.40	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_MOUSE	ANTAGONIST	Ki	9	IUPHAR
Mu-type opioid receptor	GPCR		OPRM_CAVPO		Ki	9.17	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_MOUSE		Kd	7.30	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_RAT		Kd	7.74	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_CAVPO		Ki	8.50	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_RAT		Kd	9	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_MOUSE	ANTAGONIST	IC50	8.30	IUPHAR
Mu-type opioid receptor	GPCR		OPRM_BOVIN		IC50	8.30	CHEMBL
C-C chemokine receptor type 5	GPCR		CCR5_MOUSE		Kd	7.98	CHEMBL
Opioid receptor	GPCR		OPRD_RAT OPRM_RAT OPRK_RAT SGMR1_RAT		Kd	9	CHEMBL

External reference:

ID	Source
D01340	KEGG_DRUG
51481-60-8	SECONDARY_CAS_RN
357-08-4	SECONDARY_CAS_RN
4018057	VANDF
4019852	VANDF
C0027358	UMLSCUI
CHEBI:7459	CHEBI
CHEMBL80	ChEMBL_ID
CHEMBL1718	ChEMBL_ID
DB01183	DRUGBANK_ID
D009270	MESH_DESCRIPTOR_UI
5284596	PUBCHEM_CID
1638	IUPHAR_LIGAND_ID
1526	INN_ID
36B82AMQ7N	UNII
1010598	RXNORM
2074	MMSL
221948	MMSL
27364	MMSL
5150	MMSL
71995	MMSL
d00311	MMSL
001614	NDDF
004661	NDDF
21518006	SNOMEDCT_US
371000220109	SNOMEDCT_US
372890007	SNOMEDCT_US
89018006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0188	TABLET	0.50 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0188	TABLET	0.50 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0188	TABLET	0.50 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0188	TABLET	0.50 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0189	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0189	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0189	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
buprenorphine hydrochloride and naloxone hydrochloride dihydrate	HUMAN PRESCRIPTION DRUG LABEL	2	0054-0189	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Naloxone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-2165	SPRAY, METERED	4 mg	NASAL	ANDA	23 sections
Naloxone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-2165	SPRAY, METERED	4 mg	NASAL	ANDA	23 sections
Naloxone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-2165	SPRAY, METERED	4 mg	NASAL	ANDA	23 sections
Naloxone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-2165	SPRAY, METERED	4 mg	NASAL	ANDA	23 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0121-1018	TABLET	0.50 mg	SUBLINGUAL	ANDA	31 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0121-2036	TABLET	2 mg	SUBLINGUAL	ANDA	31 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3154	TABLET	0.50 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3154	TABLET	0.50 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3154	TABLET	0.50 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3154	TABLET	0.50 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3155	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3155	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3155	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0228-3155	TABLET	2 mg	SUBLINGUAL	ANDA	33 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0378-8765	FILM	0.50 mg	SUBLINGUAL	ANDA	34 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0378-8765	FILM	0.50 mg	SUBLINGUAL	ANDA	34 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0378-8765	FILM	0.50 mg	SUBLINGUAL	ANDA	34 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0378-8766	FILM	1 mg	SUBLINGUAL	ANDA	34 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0378-8766	FILM	1 mg	SUBLINGUAL	ANDA	34 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0378-8766	FILM	1 mg	SUBLINGUAL	ANDA	34 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0378-8767	FILM	2 mg	SUBLINGUAL	ANDA	34 sections
Buprenorphine and Naloxone	HUMAN PRESCRIPTION DRUG LABEL	2	0378-8767	FILM	2 mg	SUBLINGUAL	ANDA	34 sections