Nalmefene hydrochloride - Generic Drug Details

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

Nalmefene hydrochloride is the generic ingredient in three branded drugs marketed by Chengdu Shuode, Purdue Pharma Lp, Hikma, and Indivior, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Nalmefene hydrochloride has eleven patent family members in eight countries.

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

Summary for nalmefene hydrochloride

International Patents:	11
US Patents:	1
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	30
Patent Applications:	263
Formulation / Manufacturing:	see details
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
Purdue Pharma LP	Phase 4
Nantes University Hospital	Phase 3
RenJi Hospital	Phase 4

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
Hikma	REVEX	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	020459-002	Apr 17, 1995		DISCN	Yes	No
Chengdu Shuode	NALMEFENE HYDROCHLORIDE	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	216007-001	Nov 15, 2023		RX	No	No
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
Indivior	OPVEE	nalmefene hydrochloride	SPRAY;NASAL	217470-001	May 22, 2023		RX	Yes	Yes

International Patents for nalmefene hydrochloride

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2019118465	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ПЕРЕДОЗИРОВКИ ОПИОИДАМИ
European Patent Office	3541386	COMPOSITIONS ET MÉTHODES DE TRAITEMENT D'UNE PRISE EXCESSIVE D'OPIOÏDES (COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE)
Australia	2017360910	Compositions and methods for the treatment of opioid overdose
Canada	3044221	COMPOSITIONS ET METHODES DE TRAITEMENT D'UNE PRISE EXCESSIVE D'OPIOIDES (COMPOSITIONS AND METHODS FOR THE TREATMENT OF OPIOID OVERDOSE)
Japan	2023140359	オピオイド過剰摂取を処置するための組成物および方法 (COMPOSITIONS AND METHODS FOR TREATMENT OF OPIOID OVERDOSE)