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Last Updated: December 16, 2025

MECLOMEN Drug Patent Profile


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When do Meclomen patents expire, and what generic alternatives are available?

Meclomen is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in MECLOMEN 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.

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Summary for MECLOMEN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 88
Clinical Trials: 1
DailyMed Link:MECLOMEN at DailyMed
Drug patent expirations by year for MECLOMEN
Recent Clinical Trials for MECLOMEN

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

SponsorPhase
The University of Texas Health Science Center, HoustonPhase 2

See all MECLOMEN clinical trials

US Patents and Regulatory Information for MECLOMEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis MECLOMEN meclofenamate sodium CAPSULE;ORAL 018006-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parke Davis MECLOMEN meclofenamate sodium CAPSULE;ORAL 018006-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Last updated: July 30, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: MECLOMEN

Introduction

Mecolmen (generic name: mecobalamin) is an active form of vitamin B12 widely used for neurological and hematological indications. Its global market landscape encompasses diverse therapeutic applications, manufacturing complexities, and evolving regulatory environments. This analysis explores the current market dynamics and forecasted financial trajectory of Mecolmen, spotlighting the factors influencing supply, demand, pricing, and innovation in this sector.

Overview of Mecolmen and Therapeutic Indications

Mecolmen is primarily prescribed for conditions stemming from vitamin B12 deficiency, including pernicious anemia, peripheral neuropathy, and nerve damage associated with diabetes or alcoholism. Its use extends to neurological disorders such as Alzheimer’s disease, multiple sclerosis, and certain psychiatric conditions [1]. The drug’s efficacy stems from its role in myelin sheath synthesis, nerve regeneration, and red blood cell production.

Market Dynamics

1. Growing Global Demand

The rising prevalence of neurological and hematological disorders propels demand for Mecolmen. The increase in diabetic neuropathy and aging populations in developed countries significantly contributes to sustained need. According to the World Health Organization (WHO), neuropathy affects approximately 1 in 10 adults globally, with increasing incidence among diabetic populations [2].

2. Pricing and Market Penetration

As a vitamin B12 derivative, Mecolmen benefits from relatively low manufacturing costs compared to biologics or complex small molecules. Generic versions have expanded access, especially in emerging markets such as India, China, and Latin America, where affordability shapes prescription patterns [3]. Patent expirations and regulatory approvals facilitate increased competition, pushing prices downward but expanding distribution channels.

3. Regulatory Environment and Approvals

Regulatory bodies such as the US FDA, EMA, and Health Canada have approved Mecolmen for specific indications, with some regions requiring additional clinical trials for new therapies involving B12 derivatives. Strict regulatory pathways influence launch timelines and market entry strategies, impacting overall commercial viability.

4. Supply Chain and Manufacturing Challenges

Manufacturing Mecolmen involves fermentation and chemical synthesis processes requiring strict quality controls to avoid impurities. Global supply chain disruptions, notably during the COVID-19 pandemic, caused shortages and price volatilities, emphasizing the necessity for diversified sourcing. Advances in biotechnological production methods may reduce costs and increase supply stability in the future.

5. Competitive Landscape

The market features a spectrum of branded and generic formulations. Major players include local pharmaceutical companies in India and China, alongside global incumbents with extensive distribution networks. The differentiation mainly hinges on formulation, delivery method (oral vs. injectable), and price competitiveness. Competition pressures drive innovation in delivery systems, such as sustained-release formulations, to enhance patient compliance.

Financial Trajectory and Market Forecast

1. Market Size and Forecast (2023–2030)

The global vitamin B12 market, which includes Mecolmen, was valued at approximately USD 1.5 billion in 2022, projected to grow at a CAGR of 6% through 2030 [4]. Specifically, the segment including mecobalamin is expected to see robust growth driven by increased neurological disorder treatment needs, reaching an estimated USD 2.8 billion by 2030.

2. Regional Market Performance

  • Asia-Pacific: Dominates due to high prevalence of B12 deficiency, large manufacturing base, and price-sensitive markets. India and China lead in production and consumption.
  • North America: Growth driven by aging populations and increased awareness, despite higher pricing pressures.
  • Europe: Stabilized growth with focus on regulatory compliance and clinical validation for new indications.

3. Revenue Drivers and Risks

Revenue prospects hinge on expanding therapeutic indications, improving formulations, and patent expiries of branded versions. Risks include regulatory hurdles, competition from alternative therapies (e.g., intranasal B12), and market saturation. Additionally, emerging evidence on optimal dosing and new delivery platforms could influence prescribing habits and market share distribution.

4. Investment and Innovation Trends

Companies investing in novel delivery mechanisms—such as transdermal patches, nasal sprays, or long-acting injectables—aim to capture larger market segments and improve patient adherence. Biotech innovations exploring synergistic therapies or combination drugs may also reshape the landscape, creating new revenue streams.

Future Outlook and Strategic Considerations

  • Expansion into new indications: Clinical trials exploring Mecolmen’s efficacy in neurodegenerative diseases and cognitive disorders are underway, potentially broadening market scope.
  • Partnerships and licensing deals: Collaborations with biotech firms could accelerate development and commercialization of advanced formulations.
  • Regulatory pathway optimization: Streamlining approval processes for innovative delivery systems will be vital for early market entry and competitive advantage.
  • Supply chain resilience: Diversified sourcing and manufacturing automation are essential to mitigate pandemic-related disruptions and price volatility.

Key Takeaways

  • The Mecolmen market is poised for steady growth, driven by increasing neurological and hematological disorder prevalence.
  • Price sensitivity and manufacturing efficiencies favor generic producers, especially in emerging markets.
  • Innovation in formulation and expanding therapeutic indications are critical to capturing additional market share.
  • Regulatory navigation and supply chain management remain pivotal for sustained market success.
  • Strategic collaborations and investment in novel delivery systems will enhance long-term profitability.

FAQs

Q1: What are the main factors driving the growth of Mecolmen globally?
The primary drivers include the rising prevalence of B12 deficiency-related conditions, aging populations, improved awareness of neurological health, and favorable regulatory approvals for expanding indications.

Q2: How do patent expirations influence Mecolmen’s market dynamics?
Patent expirations enable generic competition, reducing prices, broadening access, and increasing market penetration, especially in cost-sensitive regions. They also compel brand manufacturers to innovate in formulations and delivery systems to maintain market share.

Q3: What are the key challenges facing Mecolmen manufacturers?
Manufacturing complexity, supply chain disruptions, regulatory hurdles, and market saturation pose significant challenges. Ensuring quality control and cost efficiency remains critical amid increasing competition.

Q4: How might emerging delivery technologies impact Mecolmen’s market?
Innovations such as transdermal patches or nasal sprays could improve patient compliance, extend dosing intervals, and open new market segments, ultimately enhancing revenue streams.

Q5: What is the outlook for new therapeutic indications involving Mecolmen?
Ongoing clinical trials exploring neurodegenerative diseases and cognitive disorders could significantly expand Mecolmen’s repurposing opportunities, driving future growth and market diversification.

References

[1] GlobalData Healthcare. "Vitamin B12 Market Analysis," 2022.
[2] WHO. "Neurological Disorders: Public Health Challenges," 2021.
[3] IMS Health. "Generic Drug Market Trends," 2022.
[4] Grand View Research. "Vitamin B12 Market Size & Trends," 2022.

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