Last Updated: June 17, 2026

PYRIDAMAL 100 Drug Patent Profile


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Which patents cover Pyridamal 100, and what generic alternatives are available?

Pyridamal 100 is a drug marketed by Bel Mar and is included in one NDA.

The generic ingredient in PYRIDAMAL 100 is chlorpheniramine maleate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pyridamal 100

A generic version of PYRIDAMAL 100 was approved as chlorpheniramine maleate by AVANTHI INC on May 13th, 2009.

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Summary for PYRIDAMAL 100

US Patents and Regulatory Information for PYRIDAMAL 100

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bel Mar PYRIDAMAL 100 chlorpheniramine maleate INJECTABLE;INJECTION 083733-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for PYRIDAMAL 100

Last updated: March 16, 2026

What is PYRIDAMAL 100?

PYRIDAMAL 100 is a formulation containing 100 mg of pyridamole, a vasodilator and antiplatelet agent. It is primarily prescribed for preventing blood clots in certain cardiovascular conditions, including coronary artery disease, peripheral vascular disease, and after coronary artery bypass grafting. The drug has been marketed globally with varying approval statuses and patent protections.

Market Size and Demand Drivers

Global Market Overview

The global antiplatelet drugs market, which includes pyridamole, was valued at approximately USD 4.2 billion in 2022 and is projected to reach USD 6.1 billion by 2028 at a CAGR of 6.3% (CAGR 2022-2028). Pyridamole's market share within this remains modest compared to dominant agents like aspirin, clopidogrel, and ticagrelor, due to limited patent protection and alternative competition.

Key Demand Factors

  • Prevalence of Cardiovascular Diseases (CVD): According to the WHO, CVD accounts for 31% of all global deaths annually. An aging population and rising risk factors increase demand for antiplatelet therapies.

  • Off-label and Adjunct Use: Pyridamole gaining some off-label use as a diagnostic agent in stress testing elevates ancillary demand, especially in developed markets.

  • Regulatory Environment: In regions where pyridamole remains off-patent and approved, generic formulations significantly influence market penetration.

Regional Market Trends

Region Market Size (2022) Growth Rate (CAGR 2022-2028) Notes
North America USD 1.2 billion 6.1% High prevalence of CVD, mature market; off-patent status increases generics.
Europe USD 1.0 billion 6.4% Similar dynamics, with clinicians favoring combination therapies.
Asia-Pacific USD 0.9 billion 8.0% Rapid growth, expanding healthcare infrastructure, increasing CVD prevalence.
Latin America USD 0.3 billion 5.0% Emerging markets, price-sensitive, generic dominance.

Competitive Landscape

Major Competitors and Market Share

  • Aspirin: Dominates with an estimated 40% market share across global antiplatelet drugs.
  • Clopidogrel: Holds approximately 25%, with patent expired in 2012.
  • Ticagrelor and Prasugrel: Together capture roughly 20%, largely in acute settings.
  • Generic Pyridamole: Now accounts for about 10% in markets where it is approved and prescribed.

Patent and Regulatory Factors

  • The original pyridamole patent expired in the early 2000s, leading to a surge in generic versions.
  • Limited patent life extensions or new formulations have hindered proprietary market exclusivity.

Financial Trajectory

Revenue Projections

Year Estimated Global Revenue Assumptions
2023 USD 250 million Growth driven by increased prevalence, more off-label use in diagnostics.
2025 USD 300 million Market saturation, generic price competition, incremental demand.
2028 USD 350 million Steady growth in emerging markets, stable demand in developed regions.

Cost Structure and Profitability

  • Manufacturing Costs: Approximate USD 1.5 to USD 2.0 per unit for generics.
  • Pricing: Varies from USD 0.10 to USD 0.50 per tablet depending on the region.
  • Margins: Gross margins of 60-70% are typical for generic formulations.

Impact of Market Entry and Competition

  • New formulations or combination therapies could destabilize pricing.
  • Regulatory delays or bans, especially in markets with strict drug approval processes, pose risks.

Future Outlook and Risks

  • Market Maturity: Limited growth prospects where the drug is well established.
  • Emerging Markets: Offer expansion potential but face pricing pressures.
  • Regulatory Risks: Patent challenges or changing classification as a diagnostic or generic drug could affect profitability.
  • New Indications: Research into novel uses could create additional patent life or revenue streams.

Key Takeaways

  • PYRIDAMAL 100 operates in a competitive, mature market dominated by generics and low-cost alternatives.
  • The market’s growth hinges on the expanding burden of CVD and off-label diagnostic applications.
  • Revenue is projected to grow at a CAGR of roughly 6% through 2028, with regional variances heavily influencing the trajectory.
  • Patent expirations and generic competition serve as primary financial risks.
  • Strategic opportunities include developing combination therapies or exploring new indications.

FAQs

1. What factors influence PYRIDAMAL 100’s market growth?
Declining patent protections, increasing CVD prevalence, and off-label diagnostic uses drive growth, especially in emerging markets.

2. How does competition affect PYRIDAMAL's profitability?
Generic competition leads to price erosion, limiting profit margins and market share expansion.

3. Which regions present the highest growth opportunities?
Asia-Pacific and Latin America exhibit higher CAGR due to expanding healthcare infrastructure and increasing disease burden.

4. Are there regulatory barriers to market entry?
Yes; approval processes can delay commercialization, especially for new formulations or indications.

5. What strategic moves could enhance PYRIDAMAL's market position?
Developing novel combination products, securing new therapeutic indications, and expanding into underserved markets.


References

[1] MarketsandMarkets. (2023). Antiplatelet Drugs Market. Retrieved from https://www.marketsandmarkets.com/

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