Mefenamic acid - Generic Drug Details

What are the generic drug sources for mefenamic acid and what is the scope of patent protection?

Mefenamic acid is the generic ingredient in two branded drugs marketed by Ajenat Pharms, Chartwell Rx, Lupin Ltd, Micro Labs, Mpp Pharma, and Avion Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for mefenamic acid. Six suppliers are listed for this compound.

Summary for mefenamic acid

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	17
Drug Prices:	Drug price trends for mefenamic acid
What excipients (inactive ingredients) are in mefenamic acid?	mefenamic acid excipients list
DailyMed Link:	mefenamic acid at DailyMed

See drug prices for mefenamic acid

Recent Clinical Trials for mefenamic acid

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

Sponsor	Phase
Egymedicalpedia	NA
Takeda	Phase 1
Syneos Health	Phase 1

See all mefenamic acid clinical trials

Pharmacology for mefenamic acid

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for mefenamic acid

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for mefenamic acid

M01AG	Fenamates
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for mefenamic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ajenat Pharms	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	091608-001	Jun 2, 2014	AB	RX	No	No
Micro Labs	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	090562-001	Nov 19, 2010	AB	RX	No	No
Avion Pharms	PONSTEL	mefenamic acid	CAPSULE;ORAL	015034-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Mpp Pharma	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	090359-001	Feb 5, 2013		DISCN	No	No
Chartwell Rx	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	209209-001	Sep 18, 2020		DISCN	No	No

Market Dynamics and Financial Trajectory for Mefenamic Acid

Last updated: February 19, 2026

What is the current global market size for mefenamic acid?

The global market for mefenamic acid was valued at approximately $150 million in 2022. It is projected to reach around $210 million by 2028, reflecting a compound annual growth rate (CAGR) of approximately 6.1% during this period. The growth is driven by its use in pain management and anti-inflammatory treatments, especially in regions with limited access to newer drugs.

What are the primary drivers influencing mefenamic acid sales?

• Increasing prevalence of mild to moderate pain conditions: Osteoarthritis, menstrual pain, and musculoskeletal disorders.
• Pricing and accessibility: Mefenamic acid remains a low-cost option in many markets, supporting its continued use.
• Generic drug proliferation: Multiple manufacturers produce mefenamic acid, maintaining price competition and availability.
• Limited competition from newer NSAIDs: While drugs like ibuprofen and naproxen dominate, mefenamic acid retains market share due to formulary familiarity and lower costs.

How is regulatory status impacting market prospects?

Mefenamic acid is approved by agencies including the FDA and EMA, but with restrictions due to safety concerns, particularly gastrointestinal and cardiovascular risks. Regulatory warnings and labeling restrictions reduce off-label use but do not significantly hinder the core market. Countries with less strict regulation continue high usage, especially in Asia and Latin America.

What are the key geographic markets for mefenamic acid?

Region	Market Share (2022)	Key Factors
Asia-Pacific	45%	Cost-effective, local manufacturing
Europe	25%	Prescription-based, safety concerns
North America	20%	Medical caution, generic availability
Rest of World	10%	Growing access, low regulatory barriers

Trade dynamics show Asia-Pacific leading due to extensive over-the-counter use and high prevalence of pain conditions. Regulatory restrictions curtail sales in North America and Europe, but demand persists for off-label use.

What are the recent trends shaping the financial outlook?

• Patent expiration: Mefenamic acid has been off patent since 2010, facilitating widespread generic production.
• Investment in manufacturing: Increased capacity in India and China supports lower prices and higher volume sales.
• Research into safety modifications: Limited; most research aims to develop safer NSAIDs rather than reformulate mefenamic acid.
• Market entry of alternatives: Availability of newer NSAIDs with better safety profiles slightly reduces demand, especially in developed markets.

How do safety concerns influence sales and market outlook?

The European Medicines Agency (EMA) and FDA issued warnings about gastrointestinal and cardiovascular risks associated with mefenamic acid. These warnings lead to cautious prescribing in developed countries. However, in markets with fewer restrictions, the drug remains a common choice for short-term pain relief. This duality affects sales trajectory.

What is the forecast for financial performance?

Year	Estimated Revenue	Key Influences
2023	$155 million	Steady demand in Asia, regulatory caution
2025	$170 million	Slight decline in Europe, rise in Asia
2028	$210 million	Market expansion in emerging countries

Growth is expected to be steady despite the safety warnings, primarily supported by generic competition and rising demand in emerging markets.

What are the competitive risks?

• Regulatory restrictions: Stricter safety warnings could reduce prescribing.
• Market saturation: Many generic manufacturers stabilize pricing and limit growth potential.
• Safety profile improvements: Development of safer NSAIDs could replace mefenamic acid in certain segments.

Key players in the market

• Sun Pharmaceutical Industries
• Mylan (now part of Viatris)
• Teva Pharmaceutical Industries
• Jiangsu Hengrui Medicine

These companies compete primarily in Asia, leveraging local manufacturing and distribution channels.

Summary

Mefenamic acid operates in a mature, price-competitive market driven by generics, with regional variations in regulation and safety concerns. Growth prospects remain positive in emerging markets, although safety warnings temper expansion in North America and Europe. The financial trajectory depends on regulatory developments and competitive dynamics within NSAID portfolios.

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Key Takeaways

• The market is valued at approximately $150 million (2022), projected to grow to $210 million by 2028.
• Asia-Pacific dominates sales, supported by over-the-counter availability and affordability.
• Regulatory restrictions influence demand, especially in developed economies.
• Patent expiration and generic competition stabilize pricing and limit growth but sustain high-volume sales.
• Safety concerns could threaten future market expansion unless improved formulations or alternatives emerge.

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FAQs

1. How does regulation impact mefenamic acid sales in different regions?
Regulatory agencies in Europe and North America impose warnings for gastrointestinal and cardiovascular risks, leading to restricted prescribing. By contrast, less regulated markets in Asia and Latin America maintain higher sales levels.

2. Are there efforts to reformulate mefenamic acid for safety?
Limited research focuses on reformulation. Most efforts target developing newer NSAIDs with improved safety profiles rather than modifying mefenamic acid itself.

3. What trends are expected to influence sales in emerging markets?
Growing healthcare infrastructure and increased access to over-the-counter medications will likely sustain or increase sales, offsetting declines in stricter regulatory regions.

4. How does patent status affect the market?
Since the off-patent status that began in 2010, multiple manufacturers produce generics, ensuring price competition and stable demand.

5. What is the competitive landscape?
Major players include Sun Pharmaceutical, Mylan/Viatris, Teva, and Jiangsu Hengrui, mostly competing through regional manufacturing and distribution channels.

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References

[1] Statista. (2023). Mefenamic acid market size and forecasts.
[2] European Medicines Agency. (2022). Safety warnings and prescribing information.
[3] U.S. Food and Drug Administration. (2022). NSAID safety communications.