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Last Updated: December 22, 2024

MECLOFENAMATE SODIUM Drug Patent Profile


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Which patents cover Meclofenamate Sodium, and what generic alternatives are available?

Meclofenamate Sodium is a drug marketed by Am Therap, Ani Pharms, Barr, Chartwell Rx, Mylan, Par Pharm, Usl Pharma, Vitarine, and Watson Labs. and is included in eighteen NDAs.

The generic ingredient in MECLOFENAMATE SODIUM is meclofenamate sodium. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meclofenamate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Meclofenamate Sodium

A generic version of MECLOFENAMATE SODIUM was approved as meclofenamate sodium by MYLAN on September 3rd, 1986.

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Summary for MECLOFENAMATE SODIUM
Drug patent expirations by year for MECLOFENAMATE SODIUM
Recent Clinical Trials for MECLOFENAMATE SODIUM

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SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 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
Am Therap MECLOFENAMATE SODIUM meclofenamate sodium CAPSULE;ORAL 071362-001 Feb 10, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs MECLOFENAMATE SODIUM meclofenamate sodium CAPSULE;ORAL 071640-001 Aug 11, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MECLOFENAMATE SODIUM meclofenamate sodium CAPSULE;ORAL 072262-001 Nov 29, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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