MEFLOQUINE HYDROCHLORIDE - Generic Drug Details

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

Mefloquine hydrochloride is the generic ingredient in two branded drugs marketed by Roche, Barr, Chartwell Rx, Hikma, Hikma Intl Pharms, and Us Army Walter Reed, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for mefloquine hydrochloride. Three suppliers are listed for this compound.

Summary for MEFLOQUINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	77
Patent Applications:	2,467
What excipients (inactive ingredients) are in MEFLOQUINE HYDROCHLORIDE?	MEFLOQUINE HYDROCHLORIDE excipients list
DailyMed Link:	MEFLOQUINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MEFLOQUINE HYDROCHLORIDE

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

Sponsor	Phase
National Research and Innovation Agency of Indonesia	N/A
Universitas Padjadjaran	N/A
Prodia Diacro Laboratories P.T.	N/A

See all MEFLOQUINE HYDROCHLORIDE clinical trials

Pharmacology for MEFLOQUINE HYDROCHLORIDE

Drug Class

Antimalarial

Medical Subject Heading (MeSH) Categories for MEFLOQUINE HYDROCHLORIDE

Antimalarials

Anatomical Therapeutic Chemical (ATC) Classes for MEFLOQUINE HYDROCHLORIDE

P01BC	Methanolquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for MEFLOQUINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	LARIAM	mefloquine hydrochloride	TABLET;ORAL	019591-001	May 2, 1989		DISCN	Yes	No
Hikma Intl Pharms	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	077699-001	Apr 21, 2010		DISCN	No	No
Chartwell Rx	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076175-001	Feb 20, 2002	AB	RX	No	No
Us Army Walter Reed	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	019578-001	May 2, 1989		DISCN	No	No

Expired US Patents for MEFLOQUINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	LARIAM	mefloquine hydrochloride	TABLET;ORAL	019591-001	May 2, 1989	4,579,855

Market Dynamics and Financial Trajectory for Mefloquine Hydrochloride

Last updated: July 29, 2025

Introduction
Mefloquine hydrochloride, a synthetic antimalarial agent approved in the 1980s, remains relevant within the global healthcare landscape due to its efficacy against multidrug-resistant strains of Plasmodium falciparum. Despite the advent of new antimalarials, mefloquine's unique pharmacokinetic profile and longstanding clinical approval sustain its presence in the market. This analysis delineates the key market forces and fiscal trends shaping mefloquine hydrochloride’s trajectory in the pharmaceutical industry.

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Pharmacological Profile and Clinical Applications

Mefloquine hydrochloride is characterized by its long half-life (~20 days), allowing for weekly dosing regimens in malaria prophylaxis and treatment. It exhibits activity against chloroquine-resistant strains, positioning it as a critical drug in regions where resistance jeopardizes traditional therapies. Clinicians worldwide leverage its efficacy, especially in tropical zones such as Southeast Asia and sub-Saharan Africa. Currently, mefloquine also serves in combination therapies as part of multidrug regimens, emphasizing its continued clinical relevance.

Market Size and Geographic Distribution

The global antimalarial drug market was valued at approximately USD 1.2 billion in 2022, with antimalarial agents including artemisinin derivatives, chloroquine, and mefloquine accounting for a significant share. Mefloquine’s niche exists predominantly in prophylactic care and treatment in malaria-endemic regions. Its market penetration in Africa and Southeast Asia underscores a strategic position owing to resistance patterns and prescription practices. Despite a decline in global malaria mortality (WHO estimates a 14% reduction from 2019 to 2021), demand for effective prophylactics like mefloquine persists, especially among travelers and military personnel.

Market Drivers

• Resistance Challenges Drive Demand for Mefloquine
  The prevalence of chloroquine-resistant Plasmodium species fuels reliance on mefloquine. As resistance develops to other agents, healthcare providers prioritize effective alternatives, bolstering mefloquine’s market share.

• Global Malaria Control Initiatives
  Investments by WHO and global health agencies enhance access to antimalarials, including mefloquine. Multilateral funding supports procurement in endemic regions, maintaining steady demand.

• Expanding Travel and Military Operations
  Increasing international travel, including military deployments to resistant zones, sustains the prophylactic use of mefloquine, especially given its convenient weekly dosing.

• Product Development and Formulation Innovation
  Advances in sustained-release formulations and combination therapies extend therapeutic utility, contributing to the drug’s market resilience.

Market Challenges

• Side Effect Profile and Tolerability Issues
  Mefloquine’s neuropsychiatric adverse effects limit its use among some patient populations. Reports of depression, hallucinations, and other neurotoxicity concerns have prompted caution, affecting prescribing patterns.

• Competition from Newer Agents
  Artemisinin-based combination therapies dominate the treatment landscape due to superior efficacy and tolerability. These agents often replace mefloquine in treatment protocols, particularly where side effects are a concern.

• Regulatory and Patent Landscape
  Mefloquine hydrochloride’s status as a generic drug diminishes its pricing power. However, patent expirations have facilitated increased manufacturing, affecting market pricing dynamics.

Financial Trajectory and Forecasts

The financial outlook for mefloquine hydrochloride hinges on several factors:

• Moderate Growth in Endemic Regions
  The ongoing burden of malaria ensures persistent demand, albeit at largely stabilized levels. Forecasts project a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, primarily driven by procurement in low- and middle-income countries (LMICs).

• Pricing Dynamics
  As a generic medication, mefloquine opportunities for premium pricing are limited. However, procurement volumes remain significant due to large-scale public health initiatives, sustaining revenue streams.

• Market Share Stability
  Mefloquine's proportion within the overall antimalarial market is expected to remain stable, given its unique prophylactic utility but declining role in first-line treatment.

• Emerging Trends and Opportunities
  The development of combination formulations, such as MEFLOQUINE + Artesunate, could revive interest, expanding market reach and improving compliance, thus offering a positive impact on financial prospects.

Key Investing Insight:
For industry stakeholders, maintaining supply chains and investing in formulation enhancements could capitalize on its prophylactic niche and resistance-driven demand. Conversely, R&D investments might better favor newer agents for treatment applications, given the side effect profiles limiting mefloquine’s broader adoption.

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Regulatory and Patent Environment

While patent protections have mostly lapsed, the regulatory framework governing antimalarials remains robust. WHO prequalification enhances procurement confidence, especially among NGOs and global health programs. Patent expirations have facilitated generic manufacturing, leading to price reductions and increased accessibility but constraining profit margins.

Potential Market Evolution

In the upcoming decade, the market is predicted to stabilize, with modest growth associated with increased distribution in endemic regions and potential formulation innovations addressing tolerability concerns. Clinical trials exploring alternative dosing strategies and combination therapies may expand mefloquine’s applicability.

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Conclusion

Mefloquine hydrochloride sustains a strategic, albeit niche, role in malaria prophylaxis and treatment. Its market dynamics are shaped by resistance landscapes, safety concerns, and evolving therapeutic options. Financially, the compound offers stable but limited growth prospects, predominantly driven by global health initiatives and endemic region demands. Industry players should monitor developments in formulation science and resistance patterns to optimize positioning.

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Key Takeaways

• Persistent Need in Resistance Hotspots: Mefloquine’s efficacy against resistant malaria strains sustains its demand in regions with high chloroquine resistance.
• Growth Limited by Tolerability Issues: Neuropsychiatric side effects restrain widespread use, especially in developed markets.
• Market Stability via Global Health Programs: Procurement by NGOs and governments in endemic zones offers consistent revenue streams.
• Opportunities in Combination Therapies: New formulations combining mefloquine with other agents may expand its therapeutic window and improve safety profiles.
• Competitive Landscape Drives Innovation: The rise of artemisinin-based therapies challenges mefloquine’s dominance and necessitates ongoing adaptation.

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FAQs

1. Why is mefloquine still used despite its side effects?
   Its long half-life, proven efficacy against resistant strains, and weekly dosing make it a convenient prophylactic option, particularly in regions with limited alternatives.

2. How does global resistance impact mefloquine's market?
   Resistance patterns increase reliance on mefloquine in certain areas, but also prompt the development of new therapies, which can limit long-term growth.

3. Are there ongoing efforts to improve mefloquine’s safety profile?
   Yes. Research into formulations, dosing regimens, and combination therapies aims to mitigate neuropsychiatric adverse effects.

4. What is the outlook for mefloquine in malaria prevention?
   It remains a fundamental prophylactic agent in certain populations, with demand expected to remain stable in endemic regions.

5. How do patent expirations affect mefloquine’s market?
   Patent expirations promote manufacturing of generics, reducing prices but also limiting profit margins for original developers.

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Sources
[1] World Health Organization. “World Malaria Report 2022.”
[2] MarketWatch. “Global Antimalarial Drugs Market Analysis.”
[3] U.S. FDA. “Mefloquine Hydrochloride Drug Approval and Post-Market Data.”
[4] Global Data. “Pharmaceutical Industry Trends in Infectious Disease Medicinal Market.”
[5] ClinicalTrials.gov. “Research on Mefloquine Formulations and Safety.”