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 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:	274
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
Hikma	REVEX	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	020459-001	Apr 17, 1995		DISCN	Yes	No
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

International Patents for nalmefene hydrochloride

Country	Patent Number	Title	Estimated Expiration
Finland	1850892
European Patent Office	3876938	COMPOSITIONS ET PROCÉDÉS D'ADMINISTRATION D'ANTAGONISTE OPIOÏDE (COMPOSITIONS AND METHODS FOR OPIOID ANTAGONIST DELIVERY)
Canada	2900672	DISPOSITIF D'INJECTION A JET ASSISTEE PAR AIGUILLE AYANT UNE FORCE DE DECLENCHEMENT REDUITE (NEEDLE ASSISTED JET INJECTION DEVICE HAVING REDUCED TRIGGER FORCE)
Israel	266674	תכשירים ושיטות לטיפול במנה יתרה של אופיואיד (Compositions and methods for the treatment of opioid overdose)
Russian Federation	2769397	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ПЕРЕДОЗИРОВКИ ОПИОИДАМИ (COMPOSITIONS AND METHODS OF TREATING OPIOID OVERDOSE)
Spain	2763633

Nalmefene hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nalmefene Hydrochloride

Introduction to Nalmefene Hydrochloride

Nalmefene hydrochloride is an opioid antagonist that has gained significant attention in recent years due to its role in reversing opioid overdoses and managing opioid dependence. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Size and Growth Projections

The North America and Europe Nalmefene hydrochloride market was valued at US$ 4.8 million in 2022 and is projected to reach US$ 6.9 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.12% from 2023 to 2031[1].

Driving Forces

Escalating Opioid Crisis

One of the primary drivers of the Nalmefene hydrochloride market is the intensifying opioid crisis in North America and Europe. The U.S. government, for instance, allocated $4 billion in 2022 for research, treatment, and prevention efforts related to opioid misuse, a 25% increase from the previous year[1].

Investments in Healthcare Infrastructure and Research

Significant investments in healthcare infrastructure and research are bolstering the market. For example, $30 million was invested in research and development in 2022, with a notable $25 million grant funding a study that developed a novel delivery system, enhancing the drug's bioavailability by 15%[1].

Market Segmentation

Active Pharmaceutical Ingredient (API) Segment

The API segment dominates the market, capturing 77% of the revenue share. This is due to extensive research and development focused on enhancing the efficacy, safety, and potency of the API[1].

End-User Segment

Pharmaceutical companies are the major end-users, accounting for 73.19% of the revenue. Their role extends beyond commercialization to include research, clinical trials, and patient outreach, reflecting their significant investments in capital and infrastructure[1].

Regional Analysis

North America

North America holds a dominant position with a 58% revenue share in 2022. The region's socio-economic landscape, particularly the severe opioid epidemic in the United States, drives the demand for Nalmefene hydrochloride. The U.S. alone reported over 80,000 opioid addiction cases between January and September 2022[1].

Europe

While Europe also faces opioid-related challenges, the scale of the crisis is less severe compared to North America. However, the region remains a significant market due to ongoing public health efforts to combat opioid misuse[1].

Product Developments and Approvals

Nalmefene Hydrochloride Injection

Recent studies, such as the one conducted by Purdue Pharma, have examined the use of Nalmefene hydrochloride injection in emergency department settings. This product is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression[2].

Auto-Injector and Nasal Spray Formulations

The FDA approved the first nalmefene hydrochloride auto-injector, Zurnai, in August 2024, and a nasal spray formulation in May 2023. These new formulations expand the options for opioid overdose reversal and are expected to enhance market growth[4].

Regulatory Environment

The FDA's Overdose Prevention Framework has been instrumental in expediting the development and approval of opioid overdose reversal agents, including nalmefene hydrochloride. The agency's efforts to increase accessibility and availability of these drugs have been crucial in addressing the opioid crisis[4].

Financial Investments and Funding

Government Funding

The U.S. government's allocation of $4 billion in 2022 for opioid-related research and treatment underscores the financial commitment to combating the opioid epidemic. Such funding is expected to continue, driving innovation and market growth[1].

Research Grants

Significant grants, such as the $25 million grant for developing a novel delivery system, highlight the financial investments in research and development. These investments are critical for enhancing the drug's efficacy and market appeal[1].

Challenges and Opportunities

Regulatory Compliance

Despite the growth prospects, the market faces challenges in regulatory compliance. Ensuring that new formulations and delivery systems meet stringent regulatory standards is crucial for market approval and adoption[1].

Market Diversification

Market diversification remains another challenge. However, the increasing demand for effective opioid overdose reversal agents presents a significant opportunity for stakeholders to expand their market presence[1].

Key Players

Major pharmaceutical companies such as Purdue Pharma, Teva Pharmaceuticals, and others are key players in the Nalmefene hydrochloride market. These companies are driving research, development, and distribution efforts, leveraging their extensive resources and networks[3][4].

Impact on Public Health

The opioid crisis has severe public health implications, with nearly two-thirds of all overdose deaths involving opioids. The availability and accessibility of Nalmefene hydrochloride are critical in reducing overdose deaths and addressing the broader public health crisis[3].

Future Outlook

Given the persistent nature of the opioid crisis and the continuous investment in healthcare infrastructure and research, the future of the Nalmefene hydrochloride market appears robust. Innovations in formulations and delivery systems, coupled with regulatory support, are expected to propel the market forward.

"The FDA remains focused on broadening access to opioid overdose reversal agents, including naloxone and nalmefene. Today’s approval adds a new nalmefene product and route of administration to support greater options for opioid overdose reversal," - FDA Commissioner Robert M. Califf, M.D.[4]

Key Takeaways

• The Nalmefene hydrochloride market is projected to grow at a CAGR of 4.12% from 2023 to 2031.
• The escalating opioid crisis and significant government funding are key drivers of the market.
• Pharmaceutical companies dominate the market due to their extensive research and distribution networks.
• New formulations, such as auto-injectors and nasal sprays, are expanding the market's potential.
• Regulatory compliance and market diversification remain challenges but also present opportunities for growth.

FAQs

What is Nalmefene Hydrochloride used for?

Nalmefene hydrochloride is used for the complete or partial reversal of opioid drug effects, including respiratory depression, and in the management of known or suspected opioid overdose.

What are the new formulations of Nalmefene Hydrochloride?

Recent approvals include the first nalmefene hydrochloride auto-injector, Zurnai, and a nasal spray formulation, expanding the options for opioid overdose reversal.

Who are the key players in the Nalmefene Hydrochloride market?

Key players include Purdue Pharma, Teva Pharmaceuticals, and other major pharmaceutical companies involved in research, development, and distribution.

What is the projected market size of Nalmefene Hydrochloride by 2031?

The North America and Europe Nalmefene hydrochloride market is projected to reach US$ 6.9 million by 2031.

What are the main challenges facing the Nalmefene Hydrochloride market?

The main challenges include regulatory compliance and market diversification, although these also present opportunities for growth and innovation.

Sources:

1. Astute Analytica: North America & Europe Nalmefene Hydrochloride Market
2. Purdue Pharma: Study Examining Use of Nalmefene HCI Injection for Opioid Overdose Reversal in Emergency Departments
3. BioSpace: Opioids Market Size to Worth Around USD 26.78 Billion by 2034
4. FDA: FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
5. NewsChannel Nebraska: Nalmefene Hydrochloride Market Forecast to 2024-2031