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

Nalmefene hydrochloride has twenty-seven patent family members in nine countries.

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

Summary for NALMEFENE HYDROCHLORIDE

International Patents:	27
US Patents:	4
Tradenames:	4
Applicants:	4
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	35
Patent Applications:	353
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	PHASE2
National Institute on Drug Abuse (NIDA)	PHASE1
ReacX Pharmaceuticals, Inc.	PHASE1

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

Paragraph IV (Patent) Challenges for NALMEFENE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPVEE	Nasal Spray	nalmefene hydrochloride	2.7 mg/spray	217470	1	2025-04-07

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

Expired US Patents for NALMEFENE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024

International Patents for NALMEFENE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4380570
Israel	266674
Australia	2017360910
Japan	7549576
Japan	2023140359

Market Dynamics and Financial Trajectory for NALMEFENE HYDROCHLORIDE

Last updated: March 4, 2026

What is the current market landscape for nalmefene hydrochloride?

Nalmefene hydrochloride is a selective opioid receptor modulator primarily used for alcohol dependence. Its pharmaceutical profile gained approval in several markets, notably under the brand names like Selincro. The drug targeting alcohol reliance has seen an increasing interest due to the rising burden of alcohol use disorders (AUD) globally.

Market size estimate:
As of 2023, the global alcohol dependence treatment market was valued at $2.7 billion, with nalmefene playing a growing but still niche role. Growth is driven by increased awareness of AUD, expanding approval in emerging markets, and shifting regulatory landscapes favoring addiction therapy.

Regulatory status:
Nalmefene is approved in Europe (European Medicines Agency, EMA, approval in 2013) and Japan (2006) for alcohol dependence. It remains off-label in several countries, lacking FDA approval in the United States for AUD, limiting its broader market penetration.

Key competitors:
Disulfiram, naltrexone, acamprosate, and newer agents like topiramate. Naltrexone is the most prescribed in the U.S., with sales surpassing $930 million in 2022, positioning it as a benchmark.

How do market drivers influence its financial trajectory?

Rising Alcohol Use Disorders:
Global AUD prevalence exceeds 5% of the adult population, amounting to over 300 million affected individuals, which sustains demand for pharmacological interventions.

Regulatory Approvals:
New approvals in emerging markets such as Southeast Asia and Latin America expand potential patient access. Entry into these markets depends on local regulatory pathways and patent status.

Pricing and Reimbursement Trends:
Pricing varies significantly. In Europe, nalmefene can cost between $1,200 and $2,000 per treatment course. Reimbursement policies directly impact market size and revenue streams.

Patent and Market Exclusivity:
Patent expiration for key formulations in major markets is imminent or has occurred, risking generic competition. However, new formulations or delivery methods might prolong exclusivity.

Clinical Evidence and Adoption:
Mixed clinical results influence prescriber adoption. Positive trials demonstrating improved abstinence rates could bolster market share.

What are the financial prospects and challenges?

Revenue Projection:
By 2028, the global alcohol dependence treatment market is projected to reach approximately $4.5 billion, with nalmefene expected to command roughly 10-15% of this due to limited approval and competition, translating to annual revenues of roughly $150-$675 million, assuming steady market penetration.

Investment in R&D:
Pharmaceutical companies investing in new formulations or combination therapies could extend product lifespan and revenue.

Generic Competition:
Patent expiries could see a sharp decline in revenues unless new proprietary formulations emerge. The introduction of generics in the next 5-7 years could reduce prices by 40-60%, affecting profit margins.

Market Risks:
Variability in clinical trial outcomes and changing regulatory policies pose risks. Variations in reimbursement across regions influence sales performance.

How might market and financial trends evolve?

Market expansion:
Prices are likely to decrease in developed markets owing to generic entry, but increased use in emerging markets could offset these declines.

Market consolidation:
Partnerships or acquisitions among pharmaceutical majors could accelerate market penetration.

Innovation:
Development of novel delivery systems or combination products might enable better compliance and extended patent life, impacting revenue positively.

Regulatory trends:
Inclusion of nalmefene in treatment guidelines could increase prescribing rates, especially if new evidence emerges supporting its efficacy.

Summary Table: Key Data Points

Aspect	Data/Insight
Market size (2023)	$2.7 billion; projected to reach $4.5 billion by 2028
Approvals	EMA (2013), Japan (2006), limited in the U.S.
Main competitors	Naltrexone, disulfiram, acamprosate
Price per course	$1,200–$2,000 in Europe
Patent expiry	Expected in 2024–2026 in major markets
Estimated revenue (2028)	$150–$675 million (assuming 10–15% of market share)

Key Takeaways

• Nalmefene hydrochloride remains a niche but growing segment within the alcohol dependence market.
• Limited regulatory approvals constrain market potential; expansion hinges on gaining approvals elsewhere.
• Patent expiries and generic competition threaten revenue but can be countered with new formulations.
• Clinical evidence and reimbursement policies are key factors influencing adoption.
• Strategic partnerships and product innovation can extend financial viability.

Five FAQs

1. What is the primary use of nalmefene hydrochloride?
   It is used to reduce alcohol consumption in individuals with alcohol dependence.

2. Why is nalmefene not widely used in the U.S.?
   It lacks FDA approval for alcohol dependence treatment, limiting its legal availability for this indication.

3. When will generic versions likely affect nalmefene revenues?
   Patent expiration in multiple markets is expected over the next 2-3 years, increasing generic competition.

4. Can clinical outcomes influence its market success?
   Yes, new, more robust trial results can increase prescriber confidence and market share.

5. What factors could hinder market growth?
   Regulatory hurdles, patent expiries, and competition from well-established drugs like naltrexone.

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References
[1] Global Data. (2023). Alcohol dependence treatment market report.
[2] European Medicines Agency. (2013). EMA approval for nalmefene.
[3] Statista. (2022). Naltrexone sales and market share analysis.
[4] U.S. Food and Drug Administration. (2022). Drug approvals and regulatory updates.
[5] MarketWatch. (2023). Pharmaceutical market forecasts.