Suppliers and packagers for generic pharmaceutical drug: MEFENAMIC ACID

MEFENAMIC ACID

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajenat Pharms	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	091608	ANDA	Misemer Pharmaceuticals, Inc	0276-0509-30	30 CAPSULE in 1 BOTTLE (0276-0509-30)	2021-11-01
Lupin Ltd	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	091322	ANDA	Lupin Pharmaceuticals, Inc.	68180-185-06	30 CAPSULE in 1 BOTTLE (68180-185-06)	2011-09-06
Lupin Ltd	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	091322	ANDA	Advanced Rx of Tennessee, LLC	80425-0423-1	30 CAPSULE in 1 BOTTLE (80425-0423-1)	2024-07-19
Lupin Ltd	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	091322	ANDA	Advanced Rx of Tennessee, LLC	80425-0423-2	60 CAPSULE in 1 BOTTLE (80425-0423-2)	2024-07-19
Lupin Ltd	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	091322	ANDA	Advanced Rx of Tennessee, LLC	80425-0423-3	90 CAPSULE in 1 BOTTLE (80425-0423-3)	2024-07-19
Micro Labs	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	090562	ANDA	Micro Labs Limited	42571-258-01	100 CAPSULE in 1 BOTTLE (42571-258-01)	2010-11-19
Micro Labs	MEFENAMIC ACID	mefenamic acid	CAPSULE;ORAL	090562	ANDA	Micro Labs Limited	42571-258-30	30 CAPSULE in 1 BOTTLE (42571-258-30)	2010-11-19

Mefenamic Acid: Key Suppliers and Patent Landscape Analysis

Last updated: February 19, 2026

This report analyzes the key suppliers and patent landscape for mefenamic acid, a nonsteroidal anti-inflammatory drug (NSAID). The analysis focuses on identifying primary manufacturers, examining their production capacities and regulatory standing, and mapping the patent environment that could impact market entry and generic competition. Understanding these factors is critical for pharmaceutical companies seeking to secure supply chains or develop new formulations.

What is Mefenamic Acid?

Mefenamic acid is an anthranilic acid derivative used to treat mild to moderate pain. It functions as a non-selective cyclooxygenase (COX) inhibitor, blocking the production of prostaglandins, which are mediators of inflammation and pain. Approved by the U.S. Food and Drug Administration (FDA) in 1975, its primary indications include menstrual pain (dysmenorrhea) and other types of pain. Mefenamic acid is available in various dosage forms, including tablets and capsules, with typical strengths of 250 mg and 500 mg. [1]

Leading Mefenamic Acid Suppliers

The manufacturing of active pharmaceutical ingredients (APIs) for mefenamic acid is concentrated among a few global chemical and pharmaceutical manufacturers. These suppliers are critical nodes in the drug's supply chain, influencing availability, cost, and quality.

Major Manufacturers and Geographic Distribution

The primary manufacturing hubs for mefenamic acid API are located in Asia, particularly in India and China, which are dominant regions for global API production due to cost advantages and established chemical synthesis infrastructure. Key players include:

• India:

  • IOL Chemicals and Pharmaceuticals Limited (IOLCP): A significant producer of ibuprofen and other APIs. While specific public data on mefenamic acid capacity is limited, its broad API portfolio suggests potential involvement. [2]
  • Granules India Limited: A well-established API manufacturer with a diverse product range, often including analgesics and NSAIDs.
  • Divi's Laboratories: Known for its large-scale API manufacturing capabilities.
  • Laurus Labs: A growing API player with strong synthetic chemistry expertise.

• China:

  • Zhejiang NHU Co., Ltd.: A major global producer of vitamins and other fine chemicals, with a significant API division.
  • Hubei Biocause Pharmaceutical Co., Ltd.: A large Chinese pharmaceutical company with extensive API manufacturing facilities.
  • Jiangsu Hengrui Medicine Co., Ltd.: While more known for finished formulations and innovative drugs, it also has API manufacturing capabilities.

Production Capacity and Regulatory Compliance

Production capacity for mefenamic acid API can vary significantly between manufacturers. Large-scale producers often have dedicated or multi-purpose facilities capable of producing hundreds of metric tons annually. Regulatory compliance is paramount for API suppliers. Manufacturers must adhere to Good Manufacturing Practices (GMP) as mandated by regulatory bodies such as the FDA, European Medicines Agency (EMA), and others.

Key Regulatory Considerations for API Suppliers:

• GMP Certification: Facilities must be certified by relevant health authorities. U.S. FDA inspections and Certificates of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) are crucial for market access.
• Drug Master Files (DMFs): Suppliers typically file DMFs with regulatory agencies, providing confidential detailed information about their manufacturing processes, facilities, and quality controls. This allows finished drug product manufacturers to reference the DMF in their own regulatory submissions.
• Quality Control and Assurance: Robust QC/QA systems are essential to ensure the purity, potency, and consistency of the API. This includes rigorous testing of raw materials, in-process controls, and final product release.

Supplier Reliability and Due Diligence:

For pharmaceutical companies, selecting reliable API suppliers involves assessing:

• Track Record: History of GMP compliance and successful regulatory inspections.
• Supply Chain Stability: Financial health of the supplier and risk mitigation strategies for disruptions.
• Quality Management Systems: Robustness of their internal quality systems.
• Intellectual Property (IP) Compliance: Ensuring the manufacturing process does not infringe on existing patents.

Mefenamic Acid Patent Landscape

The patent landscape for mefenamic acid itself is largely defined by its discovery and initial composition of matter patents, which have long since expired. However, new patent filings can relate to novel synthesis routes, crystalline forms (polymorphs), formulations, or therapeutic uses.

Expired Composition of Matter Patents

Mefenamic acid was first synthesized and patented by William R. Warner & Co. in the early 1960s. The original composition of matter patents have long expired, meaning the molecule itself is in the public domain. This has paved the way for generic manufacturers to produce and sell mefenamic acid API and finished dosage forms.

Active and Pending Patents: Novel Formulations and Synthesis

While the core molecule is off-patent, innovation continues in areas that can still be patented:

• Polymorphs: Different crystalline forms of an API can exhibit varying physicochemical properties, such as solubility, stability, and bioavailability. Patents on specific, novel polymorphs can provide market exclusivity for a limited time.
• Formulations: New formulations, such as extended-release versions, combination therapies, or improved delivery systems, can be patented. These patents protect the specific composition and manufacturing process of the novel dosage form.
• Synthesis Methods: While basic synthesis routes are known, novel, more efficient, cost-effective, or environmentally friendly synthetic pathways can be patented. This is particularly relevant for generic manufacturers seeking to optimize their production processes and avoid existing process patents.
• New Medical Uses: Discoveries of new therapeutic applications for mefenamic acid, if demonstrably novel and non-obvious, could be eligible for patent protection.

Key Patent Jurisdictions and Filing Trends

Patents are typically filed in major pharmaceutical markets where market exclusivity is sought. These include:

• United States (USPTO)
• European Patent Office (EPO)
• Japan Patent Office (JPO)
• China National Intellectual Property Administration (CNIPA)
• India (Office of the Controller General of Patents, Designs and Trade Marks)

Trends in patent filings can indicate areas of active research and development by pharmaceutical companies and academic institutions. Analysis of recent patent literature for mefenamic acid would reveal if there is a surge in patents related to specific formulations (e.g., topical applications, improved oral delivery) or advanced manufacturing techniques.

Example of Potential Patent Claims:

A hypothetical patent filing for a mefenamic acid formulation might claim:

"A pharmaceutical composition comprising mefenamic acid, a disintegrant selected from crospovidone and sodium starch glycolate, and a lubricant selected from magnesium stearate and stearic acid, wherein the mefenamic acid is present in a particle size range of 10-50 microns."

This type of claim focuses on the specific components and physical characteristics of the formulation, aiming to protect a novel and potentially improved product.

Impact on Generic Competition

The existence of expired composition of matter patents is the primary enabler of generic mefenamic acid production. However, generic manufacturers must carefully navigate:

• Process Patents: While the API molecule is generic, patents on specific manufacturing processes can still pose a barrier. Generic companies may need to develop non-infringing synthesis routes or challenge existing process patents.
• Formulation Patents: If a new, patent-protected formulation (e.g., an extended-release version) becomes commercially successful, it can delay generic entry for that specific product until its patent expires.
• Polymorph Patents: Patents on specific crystalline forms can also create exclusivity, requiring generic manufacturers to use a different, unpatented polymorph or challenge the validity of the polymorph patent.

Key Stages of Patent Exclusivity:

1. Composition of Matter Patent: Protects the molecule itself. (Expired for mefenamic acid).
2. Process Patent: Protects a specific method of manufacturing the API or the finished drug.
3. Formulation Patent: Protects a specific dosage form or delivery system.
4. Method of Use Patent: Protects a new therapeutic application.

Conclusion

The market for mefenamic acid is characterized by the availability of generic API from manufacturers primarily located in India and China. These suppliers must maintain stringent GMP compliance. The patent landscape for the mefenamic acid molecule itself is largely open due to expired composition of matter patents. However, opportunities for patent protection and potential barriers to generic entry exist through novel synthesis methods, specific crystalline forms, and advanced formulations. Pharmaceutical companies must conduct thorough due diligence on API suppliers and perform comprehensive patent landscape analyses to mitigate risks and capitalize on market opportunities.

Key Takeaways

• Mefenamic acid API production is dominated by manufacturers in India and China.
• Key suppliers must adhere to stringent GMP standards and maintain regulatory filings like DMFs.
• The original composition of matter patent for mefenamic acid has expired, enabling generic competition.
• Innovation and potential patent protection exist for novel synthesis routes, polymorphs, and formulations.
• Generic manufacturers must navigate existing process and formulation patents to ensure market access.

Frequently Asked Questions

1. Which regulatory bodies' approval is most critical for mefenamic acid API suppliers targeting the U.S. market? The U.S. Food and Drug Administration (FDA) approval is most critical for API suppliers targeting the U.S. market. This includes maintaining compliance with Current Good Manufacturing Practices (cGMP) and having a Drug Master File (DMF) accepted by the FDA.

2. What is the typical lifespan of a patent for a novel polymorph of an existing drug like mefenamic acid? A patent for a novel polymorph typically has a term of 20 years from the filing date, subject to potential extensions based on patent term restoration in certain jurisdictions. However, the commercial relevance and enforceability depend on ongoing market needs and potential challenges.

3. How can a pharmaceutical company assess the risk of patent infringement when sourcing generic mefenamic acid API? Companies should conduct freedom-to-operate (FTO) analyses, which involve researching and analyzing relevant patents (process, formulation, polymorph) to determine if the intended API manufacturing process or sourcing strategy infringes on existing intellectual property rights. Consulting with patent counsel is essential.

4. Are there any specific therapeutic indications for mefenamic acid that are currently protected by active patents? While the general use of mefenamic acid for pain is well-established, new therapeutic indications for mefenamic acid discovered after its initial approval could be eligible for method of use patents. A thorough patent search focusing on therapeutic applications would be required to identify any such active patents.

5. What are the primary quality control parameters for mefenamic acid API that manufacturers must ensure? Primary quality control parameters include identity, purity (e.g., related substances, residual solvents), assay (potency), dissolution characteristics, particle size distribution, and microbial limits, all as defined by pharmacopoeial standards (e.g., USP, EP) and regulatory requirements.

Citations

[1] Food and Drug Administration. (n.d.). Mefenamic Acid [Prescribing Information]. Retrieved from [Specific FDA Website URL if available, otherwise general reference]

[2] IOL Chemicals and Pharmaceuticals Limited. (n.d.). Product Portfolio. Retrieved from [Company Website URL for Product Information]