Nalmefene hydrochloride - Generic Drug Details

What are the generic drug sources for nalmefene hydrochloride and what is the scope of freedom to operate?

Nalmefene hydrochloride is the generic ingredient in four branded drugs marketed by Chengdu Shuode, Purdue Pharma Lp, Hikma, and Indivior, and is included in five NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nalmefene hydrochloride has eighty patent family members in fifteen countries.

There are four drug master file entries for nalmefene hydrochloride. Three suppliers are listed for this compound.

Summary for nalmefene hydrochloride

International Patents:	80
US Patents:	22
Tradenames:	4
Applicants:	4
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	31
Patent Applications:	263
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nalmefene hydrochloride
What excipients (inactive ingredients) are in nalmefene hydrochloride?	nalmefene hydrochloride excipients list
DailyMed Link:	nalmefene hydrochloride at DailyMed

Recent Clinical Trials for nalmefene hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Tharimmune Inc	Phase 1
Purdue Pharma LP	Phase 4
Nantes University Hospital	Phase 3

See all nalmefene hydrochloride clinical trials

Pharmacology for nalmefene hydrochloride

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for nalmefene hydrochloride

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for nalmefene hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		RX	Yes	Yes			Y
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		RX	Yes	Yes			Y
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		RX	Yes	Yes			Y
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		RX	Yes	Yes			Y
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		RX	Yes	Yes			Y
Purdue Pharma Lp	NALMEFENE HYDROCHLORIDE	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	212955-001	Feb 8, 2022	AP	RX	No	Yes
Hikma	REVEX	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	020459-001	Apr 17, 1995		DISCN	Yes	No

International Patents for nalmefene hydrochloride

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2019118465	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ПЕРЕДОЗИРОВКИ ОПИОИДАМИ
Japan	2019150661	注射装置で使用するためのシリンジ緩衝器 (SYRINGE SHOCK ABSORBER FOR USE IN INJECTION DEVICE)
Brazil	PI0614025	injetores de jato
European Patent Office	4186545	ADMINISTRATION PAR INJECTION PAR JET ASSISTÉE PAR AIGUILLE DE COMPOSITIONS DE TESTOSTÉRONE (NEEDLE ASSISTED JET INJECTION ADMINISTRATION OF TESTOSTERONE COMPOSITIONS)
Canada	2595730	INJECTEUR A SERINGUE PREREMPLIE ASSISTE D'UNE AIGUILLE (PREFILLED NEEDLE ASSISTED JET INJECTOR)
South Korea	20150011346	NEEDLE ASSISTED JET INJECTION ADMINISTRATION OF TESTOSTERONE COMPOSITIONS
European Patent Office	2953667	DISPOSITIF D'INJECTION À JET ASSISTÉE PAR AIGUILLE AYANT UNE FORCE DE DÉCLENCHEMENT RÉDUITE (NEEDLE ASSISTED JET INJECTION DEVICE HAVING REDUCED TRIGGER FORCE)