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-five 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:	25
US Patents:	4
Tradenames:	4
Applicants:	4
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	34
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
University of New Mexico	PHASE3
Tharimmune Inc	Phase 1

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		DISCN	Yes	No			Y
Purdue Pharma Lp	NALMEFENE HYDROCHLORIDE	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	212955-001	Feb 8, 2022	AP	RX	No	Yes
Indivior	OPVEE	nalmefene hydrochloride	SPRAY;NASAL	217470-001	May 22, 2023		RX	Yes	Yes
Hikma	REVEX	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	020459-002	Apr 17, 1995		DISCN	Yes	No
Indivior	OPVEE	nalmefene hydrochloride	SPRAY;NASAL	217470-001	May 22, 2023		RX	Yes	Yes			Y

International Patents for nalmefene hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	3118708	COMPOSITIONS ET PROCEDES D'ADMINISTRATION D'ANTAGONISTE OPIOIDE (COMPOSITIONS AND METHODS FOR OPIOID ANTAGONIST DELIVERY)
Russian Federation	2769397	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ПЕРЕДОЗИРОВКИ ОПИОИДАМИ (COMPOSITIONS AND METHODS OF TREATING OPIOID OVERDOSE)
Australia	2024201047	Compositions and methods for the treatment of opioid overdose
Japan	7312698
Japan	2022516595	オピオイドアンタゴニストを送達するための組成物及び方法

Market Dynamics and Financial Trajectory of Nalmefene Hydrochloride

Last updated: July 30, 2025

Introduction

Nalmefene Hydrochloride, a selective opioid receptor antagonist, has garnered increasing attention within the pharmaceutical landscape primarily for its role in managing alcohol dependence and potentially addressing opioid overdose. As the global burden of substance use disorders escalates, understanding the market dynamics and projected financial trajectory of Nalmefene Hydrochloride becomes crucial for stakeholders including pharmaceutical companies, investors, healthcare providers, and policymakers.

Pharmacological Profile and Therapeutic Indications

Nalmefene Hydrochloride functions as a mu-opioid receptor antagonist with high affinity, offering clinical utility in attenuating alcohol craving and intake at low doses. Its mechanism involves reducing the reinforcing effects of alcohol, thereby supporting sustained abstinence. Although initially approved in Europe for alcohol dependence, its off-label applications and investigational use in opioid overdose have expanded its therapeutic scope.

Global Market Landscape

Market Adoption and Regulatory Status

Nalmefene Hydrochloride’s market penetration varies considerably across regions due to regulatory approvals and clinician acceptance. The European Medicines Agency (EMA) approved its use in the EU in 2013 under the brand Selincro (sold by Lundbeck), marking a significant milestone. Conversely, the U.S. Food and Drug Administration (FDA) has yet to approve Nalmefene for widespread clinical use, limiting its presence in North America.

Regulatory dynamics significantly shape market growth trajectories. Approval in key jurisdictions like the EU coupled with ongoing clinical trials underpin optimism around future adoption. However, regulatory hesitations stemming from safety profiles, cost considerations, and alternative therapies influence market expansion.

Competitive Market Forces

Nalmefene faces competition from established treatments for alcohol dependence, such as Naltrexone and Acamprosate. While Naltrexone enjoys broader regulatory approval and market penetration, Nalmefene's advantage lies in its dosing flexibility and favorable side-effect profile in some cases. The competitive landscape is further complicated by emerging agents and behavioral interventions competing for attention.

Market Drivers

• Rising Burden of Alcohol Use Disorder (AUD): According to WHO, approximately 283 million individuals globally suffer from AUD, emphasizing the need for effective pharmacotherapies.
• Unmet Medical Needs: Existing treatments have limitations concerning adherence, side effects, and efficacy, paving the way for newer agents like Nalmefene.
• Increased Awareness and Screening: Improved detection of AUD and related disorders boosts demand for pharmacological interventions.
• Policy and Reimbursement Initiatives: Health policies promoting addiction treatment can catalyze market growth, especially in Europe where Nalmefene is integrated into clinical guidelines.

Market Restraints

• Limited Regulatory Approvals: Lack of FDA approval constrains market share in lucrative North American markets.
• Safety Profile Concerns: Reports of adverse events have led to cautious regulatory and clinician adoption.
• Pricing and Reimbursement Challenges: High treatment costs and limited reimbursement options hamper patient access.

Financial Trajectory and Investment Outlook

Market Size and Revenue Projection

The global pharmaceutical market for AUD treatments was valued at approximately USD 2 billion in 2021, with Naltrexone accounting for the majority share. Nalmefene's niche position, primarily in Europe, but with growing interest elsewhere, projects a compound annual growth rate (CAGR) of roughly 8-10% over the next five years, contingent on regulatory developments and clinical evidence accumulation (source: MarketWatch estimates).

Key Revenue Streams

• Direct Sales in Approved Regions: Pharmaceutical companies marketing Nalmefene generate revenues via direct drug sales, influenced by market penetration, pricing strategies, and reimbursement policies.
• Research and Development: Ongoing clinical trials exploring novel indications or improved formulations could unlock future revenue.
• Licensing and Partnerships: Strategic collaborations with regional pharmaceutical firms can extend market reach and generate licensing income.

Investment and R&D Dynamics

Investment in clinical trials remains essential for expanding Nalmefene’s indications and securing regulatory approvals. Notably, recent Phase II and III trials focusing on opioid overdose management and co-occurring psychiatric conditions have the potential to diversify revenue streams and enhance market valuation.

Key Market Players

Major players include:

• H. Lundbeck A/S: Pioneered approval and marketing of Selincro (Nalmefene) in Europe.
• Red Hill BioPharma: Engaged in clinical research exploring Nalmefene's broader applications.
• Indivior and Zynerba: While focused heavily on opioid dependence and novel formulations, they may enter Nalmefene partnerships in the future.

Future Outlook

The trajectory for Nalmefene Hydrochloride hinges on regulatory approvals outside Europe, demonstrated clinical benefits, and cost-effective formulations. With the global focus on addressing substance use disorders, especially amid the opioid crisis and rising AUD prevalence, Nalmefene stands to carve out a niche within the evolving addiction pharmaco-therapeutics market.

Improvements in delivery mechanisms—such as long-acting formulations—and expansion into opioid overdose reversal indications present significant growth prospects. The potential for off-label prescribing, stimulated by accumulating evidence, may further influence its financial landscape.

Regulatory and Market Risks

• Approval Delays or Denials: Restrictive regulatory decisions can inhibit market entry.
• Adverse Events and Safety Concerns: Negative safety profiles could diminish clinician confidence.
• Competitive Displacement: Other therapies or emerging drugs could overshadow Nalmefene's market share.

Key Takeaways

• Expanding Therapeutic Scope: Clinical research on opioid overdose reversal and wider psychiatric indications could diversify revenue streams.
• Regulatory Progress with High Impact: Achieving approvals in North America and Asia would markedly elevate market size.
• Regional Focus: The EU remains the core market, with potential growth in emerging markets driven by increasing AUD awareness.
• Investment in R&D: Continued clinical trials and formulation innovations are vital to sustain growth momentum.
• Market Challenges: Competition with Naltrexone and regulatory hurdles necessitate strategic positioning.

FAQs

1. What are the primary therapeutic uses of Nalmefene Hydrochloride?
Nalmefene is mainly indicated for reducing alcohol consumption in adults with alcohol dependence. Emerging studies explore its potential in opioid overdose management, although it is not yet widely approved for this indication.

2. Why has Nalmefene been more successful in Europe than in other regions?
European regulatory agencies approved Nalmefene (as Selincro) based on clinical trials demonstrating efficacy and safety. In contrast, the FDA has not granted approval, partly due to concerns over safety data and a lack of substantial evidence aligning with North American standards.

3. How does Nalmefene compare to Naltrexone?
Both are opioid antagonists used in alcohol dependence. Nalmefene offers shorter dosing intervals, better tolerability profiles for some patients, and potentially fewer hepatic concerns. However, Naltrexone has broader regulatory approval and a more established market presence.

4. What factors could accelerate Nalmefene's market growth?
Key drivers include regulatory approvals outside Europe, positive clinical trial outcomes, increased awareness of AUD, and strategic partnerships enabling wider distribution.

5. What are the main risks associated with investments in Nalmefene?
Regulatory setbacks, safety concerns, competition from established therapies, and reimbursement challenges pose significant risks to financial gains.

Sources

1. World Health Organization. "Global status report on alcohol and health." 2018.
2. European Medicines Agency. Selincro (Nalmefene) Summary of Product Characteristics.
3. MarketWatch. "Global Alcohol Dependence Drugs Market Outlook." 2022.
4. ClinicalTrials.gov. Search for Nalmefene-related clinical studies.
5. Bloomberg Intelligence. "Pharmaceutical Industry Outlook 2023."