Meclofenamate sodium - Generic Drug Details

What are the generic sources for meclofenamate sodium and what is the scope of freedom to operate?

Meclofenamate sodium is the generic ingredient in three branded drugs marketed by Quantum Pharmics, Am Therap, Ani Pharms, Barr, Chartwell Rx, Mylan, Par Pharm, Usl Pharma, Vitarine, Watson Labs, and Parke Davis, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for meclofenamate sodium. One supplier is listed for this compound.

Summary for meclofenamate sodium

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	21
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	1
What excipients (inactive ingredients) are in meclofenamate sodium?	meclofenamate sodium excipients list
DailyMed Link:	meclofenamate sodium at DailyMed

Recent Clinical Trials for meclofenamate sodium

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all meclofenamate sodium clinical trials

US Patents and Regulatory Information for meclofenamate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Usl Pharma	MECLOFENAMATE SODIUM	meclofenamate sodium	CAPSULE;ORAL	071007-001	Mar 25, 1988		DISCN	No	No
Par Pharm	MECLOFENAMATE SODIUM	meclofenamate sodium	CAPSULE;ORAL	072078-001	Mar 10, 1988		DISCN	No	No
Am Therap	MECLOFENAMATE SODIUM	meclofenamate sodium	CAPSULE;ORAL	071363-001	Feb 10, 1987		DISCN	No	No
Watson Labs	MECLOFENAMATE SODIUM	meclofenamate sodium	CAPSULE;ORAL	070401-001	Nov 25, 1986		DISCN	No	No

Meclofenamate sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Meclofenamate Sodium

Introduction

Meclofenamate sodium, a nonsteroidal anti-inflammatory drug (NSAID), has been a significant player in the pharmaceutical market since its approval in 1980. Here, we will delve into the market dynamics and financial trajectory of this drug, exploring its clinical efficacy, market positioning, and financial performance.

Clinical Efficacy and Therapeutic Uses

Meclofenamate sodium has demonstrated anti-inflammatory, analgesic, and antipyretic activities, making it a versatile treatment option for various conditions. It is commonly used for rheumatoid arthritis, osteoarthritis, mild to moderate pain, dysmenorrhea, and heavy menstrual blood loss (MBL)[1][3][4].

• Rheumatoid Arthritis and Osteoarthritis: Clinical trials have shown that meclofenamate sodium is comparable to aspirin in efficacy for these conditions, with significant reductions in tender joints, morning stiffness, and pain on walking[1][3].
• Pain Management: The drug provides significant pain relief for episiotomy and dental pain, with an onset of action within one hour and a duration of 4 to 6 hours[1][3].
• Dysmenorrhea and Menorrhagia: Meclofenamate sodium reduces symptoms associated with dysmenorrhea and decreases menstrual blood loss, improving quality of life for affected women[1][3].

Market Positioning

Meclofenamate sodium is positioned as a mid-tier NSAID, offering a balance between efficacy and safety profile.

• Competitive Landscape: The NSAID market is highly competitive, with drugs like ibuprofen, naproxen, and celecoxib. However, meclofenamate sodium's unique profile, particularly its effectiveness in reducing menstrual blood loss, sets it apart[1][3].
• Prescription and Over-the-Counter (OTC) Sales: While primarily prescribed, the drug's availability in some regions as an OTC medication expands its market reach.

Financial Performance

The financial trajectory of meclofenamate sodium is influenced by several factors, including its approval status, patent life, and market demand.

• Approval and Patent History: Initially developed by Pfizer Inc., meclofenamate sodium was first approved in the US in 1980. The patent has since expired, allowing generic versions to enter the market[4].
• Revenue Trends: The revenue from meclofenamate sodium has seen fluctuations over the years. While it was a significant revenue generator in the 1980s and 1990s, the introduction of newer NSAIDs and the expiration of its patent have led to a decline in sales. However, it remains a profitable drug due to its niche uses and continued prescription by healthcare providers[4].

Cost-Effectiveness

The cost-effectiveness of meclofenamate sodium is an important factor in its market dynamics.

• Clinical and Economic Evidence: Studies have shown that meclofenamate sodium is cost-effective compared to other NSAIDs, particularly in the management of rheumatoid arthritis and dysmenorrhea. Its ability to reduce menstrual blood loss and improve quality of life contributes to its economic benefits[2][3].

Safety Profile and Regulatory Considerations

The safety profile of meclofenamate sodium impacts its market dynamics and financial performance.

• Adverse Reactions: While generally well-tolerated, meclofenamate sodium is associated with gastrointestinal reactions, such as diarrhea, and should be used with caution to avoid serious gastrointestinal events like bleeding and ulceration[1][3][5].
• Regulatory Compliance: The drug must comply with regulatory standards, and any changes in regulatory requirements can affect its market position and financial performance.

Future Prospects

The future prospects of meclofenamate sodium are tied to several factors, including innovative delivery systems and potential new indications.

• Innovative Delivery Systems: Research into novel delivery systems, such as hollow magnetic iron oxide nanoparticles, could enhance the drug's bioavailability and reduce side effects, potentially boosting its market appeal[5].
• New Indications: Ongoing studies exploring the antitumor effects of meclofenamate sodium could open new therapeutic areas, increasing its market value[5].

Key Takeaways

• Clinical Efficacy: Meclofenamate sodium is effective in treating various inflammatory and pain conditions.
• Market Positioning: It holds a mid-tier position in the NSAID market with unique benefits.
• Financial Performance: Revenue has declined post-patent expiration but remains significant due to niche uses.
• Cost-Effectiveness: It is cost-effective, particularly in managing rheumatoid arthritis and dysmenorrhea.
• Safety Profile: Associated with gastrointestinal reactions, necessitating cautious use.
• Future Prospects: Innovative delivery systems and potential new indications could revitalize its market presence.

FAQs

Q1: What are the primary therapeutic uses of meclofenamate sodium? Meclofenamate sodium is primarily used for rheumatoid arthritis, osteoarthritis, mild to moderate pain, dysmenorrhea, and heavy menstrual blood loss.

Q2: How does meclofenamate sodium compare to other NSAIDs in terms of efficacy? Meclofenamate sodium has been shown to be comparable to aspirin in efficacy for rheumatoid arthritis and osteoarthritis, with a unique benefit in reducing menstrual blood loss.

Q3: What are the common adverse reactions associated with meclofenamate sodium? Common adverse reactions include gastrointestinal reactions such as diarrhea, and it should be used cautiously to avoid serious gastrointestinal events.

Q4: Has the patent for meclofenamate sodium expired? Yes, the patent for meclofenamate sodium has expired, allowing generic versions to enter the market.

Q5: Are there any ongoing studies or new indications for meclofenamate sodium? Yes, there are ongoing studies exploring the antitumor effects of meclofenamate sodium and innovative delivery systems to enhance its bioavailability.

Sources

1. DailyMed: Meclofenamate Sodium - DailyMed
2. NCBI Books: Evidence review for the clinical and cost effectiveness of oral, topical ...
3. Drugs.com: Meclofenamate: Package Insert / Prescribing Information - Drugs.com
4. Synapse: Meclofenamate Sodium - Drug Targets, Indications, Patents - Synapse
5. MedCrave: Hollow Magnetic Iron Oxide Nanoparticles as Sodium ... - MedCrave