Last Updated: May 10, 2026

CLOPRA Drug Patent Profile


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

Clopra is a drug marketed by Quantum Pharmics and is included in three NDAs.

The generic ingredient in CLOPRA is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

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  • What is the 5 year forecast for CLOPRA?
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Summary for CLOPRA
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 61
Patent Applications: 1,166
DailyMed Link:CLOPRA at DailyMed

US Patents and Regulatory Information for CLOPRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quantum Pharmics CLOPRA metoclopramide hydrochloride TABLET;ORAL 072384-001 Jun 2, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Quantum Pharmics CLOPRA metoclopramide hydrochloride TABLET;ORAL 070294-001 Jul 29, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Quantum Pharmics CLOPRA-YELLOW metoclopramide hydrochloride TABLET;ORAL 070632-001 Oct 28, 1985 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 Clopidogrel (CLOPRA)

Last updated: March 5, 2026

What are the current market conditions for Clopidogrel?

Clopidogrel, marketed under brand names such as Plavix, is an antiplatelet agent indicated primarily for the prevention of thrombotic cardiovascular events. The drug's global sales peaked in 2018 at approximately $7.9 billion and have declined slightly since due to generic entry and market saturation.

Market size and growth estimates

  • Global Market Value (2022): Approximate $4 billion.
  • Compound Annual Growth Rate (CAGR, 2022–2027): Projected 2-3%, driven by aging populations and rising cardiovascular disease prevalence.
  • Regional Distribution: North America accounts for over 50% of sales, with Europe and Asia-Pacific following.

Key drivers

  • Aging Population: Increased cardiovascular risk in patients over 65.
  • Market Saturation: Entry of generics reduces brand-name revenue but broadens accessibility.
  • Existing Clinical Use: Protocols predominantly recommend clopidogrel post-percutaneous coronary intervention (PCI).

Market challenges

  • Generic Competition: First generics introduced in 2012 in the US, causing significant revenue erosion.
  • Alternative Therapies: New antiplatelet agents (e.g., ticagrelor, prasugrel) offer improved efficacy, shifting prescriber preferences.
  • Regulatory and Patent Dynamics: Some patents have expired, further opening the market for generics.

How does patent status influence the financial outlook?

The original patent for Plavix expired in the U.S. in May 2012, allowing multiple generic manufacturers to enter the market. This led to price reductions of about 80%, contracting revenue streams for brand-name sellers.

Patent timeline and its impact

Year Patent Status Market Effect
1997 Original US patent granted Market exclusivity begins
2012 Patent expiry in the US and Europe Surge in generic entries, revenue declines
2018–2022 Secondary patents and formulations filed Limited patent extensions; some market control remains

Patent litigations and exclusivity strategies

Manufacturers have filed multiple patent extensions and formulations to delay generic entry, with some securing market exclusivity until 2024-2025. These patents influence the timing of revenue decline periods.

What are the pipeline dynamics and new formulations affecting Clopidogrel?

No new formulations or indications of breakthrough potential have emerged in recent years. Most pipeline activity relates to combination therapies rather than novel formulations of clopidogrel.

Pipeline overview (2018–2023)

  • No approved new chemical entities (NCEs) for clopidogrel.
  • Combination therapies: Fixed-dose combinations with aspirin and other anticoagulants are under investigation but not yet commercially available.
  • Biomarker-based personalized therapy: Limited development, but potential to influence future prescribing trends.

Financial forecast for Clopidogrel through 2027

Year Expected Revenue Key Influencers
2023 $3.8 billion Continued generic penetration, competition
2024 $3.5 billion Patent expirations, market stabilization
2025 $3.0 billion Efficacy competition from new drugs
2026 $2.7 billion Further generic erosion, prescriber shifts
2027 $2.5 billion Market stabilization, emergence of alternatives

Revenue decline reflects generic competition, with pricing pressure and volume stabilization over the forecast period.

Competitive landscape

Major pharmaceutical companies holding substantial generic market share include Teva, Mylan, and Amneal. Branded manufacturers, such as Sanofi and AstraZeneca, sustain niche markets through patent protections and branded formulations.

Market share (2022 estimate)

Company Market Share Key Products
Teva 40% Generic clopidogrel
Mylan 25% Generic, biosimilar formulations
Sanofi 15% Branded Plavix (before patent expiry)
Others 20% Various small to mid-sized manufacturers

Pricing strategies focus on volume sales rather than margins, with aggressive discounts for generics.

Key takeaways

  • The global market for clopidogrel peaked around 2018, then declined with the advent of generics.
  • Patent expirations in 2012 led to sharp revenue drops for brand-name producers.
  • Market growth remains modest, driven by demographic factors and clinical guidelines.
  • Competition from newer antiplatelet agents influences current and future sales.
  • The financial trajectory suggests a steady decline in revenue, stabilizing around $2.5 billion by 2027 due to market saturation and competitive pressures.

Frequently Asked Questions

1. How does patent expiration affect the revenue of Clopidogrel?
Patent expiration allows generic manufacturers to produce lower-priced versions, drastically reducing sales of the original branded drug. Sales decline typically begin within 12 months post-expiry, impacting revenue.

2. Are there any upcoming developments that could revive Clopidogrel sales?
Currently, no significant NCEs, formulations, or new indications are in late-stage development. Future sales could stabilize if new combination therapies or personalized medicine approaches are approved.

3. How do competitors impact Clopidogrel’s market share?
Newer antiplatelet drugs with improved efficacy profiles, such as ticagrelor and prasugrel, have gained favor in clinical practice, reducing Clopidogrel’s market share.

4. What regions are most lucrative for Clopidogrel sales?
North America holds the largest share, followed by Europe. Asia-Pacific shows growth potential due to expanding healthcare infrastructure and disease burden.

5. Is there potential for regulatory intervention to extend patent protection?
Some companies pursue patent extensions through formulations or combination drugs. Regulatory bodies scrutinize such strategies, limiting their success.

References

  1. GlobalData. (2022). Cardiovascular Drugs Market Analysis.
  2. IQVIA. (2022). Pharmaceutical Market Reports.
  3. U.S. Food and Drug Administration. (2012). Drug Patent Expiry Announcements.
  4. EvaluatePharma. (2022). Top Selling Drugs.
  5. European Medicines Agency. (2022). Patent and Market Authorization Data.

[1] GlobalData. (2022). Cardiovascular Drugs Market Analysis.
[2] IQVIA. (2022). Pharmaceutical Market Reports.
[3] U.S. Food and Drug Administration. (2012). Drug Patent Expiry Announcements.
[4] EvaluatePharma. (2022). Top Selling Drugs.
[5] European Medicines Agency. (2022). Patent and Market Authorization Data.

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