Last Updated: May 10, 2026

CALCIPARINE Drug Patent Profile


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

Calciparine is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in CALCIPARINE is heparin calcium. There are seventy-seven drug master file entries for this compound. Additional details are available on the heparin calcium profile page.

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Summary for CALCIPARINE
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 2
DailyMed Link:CALCIPARINE at DailyMed
Recent Clinical Trials for CALCIPARINE

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SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 2
GlaxoSmithKline

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US Patents and Regulatory Information for CALCIPARINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us CALCIPARINE heparin calcium INJECTABLE;INJECTION 018237-001 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 Calciparine

Last updated: April 13, 2026

What is Calciparine?

Calciparine is a low molecular weight heparin (LMWH) derived from unfractionated heparin. It is used primarily as an anticoagulant to prevent and treat thromboembolic disorders, including deep vein thrombosis (DVT), pulmonary embolism (PE), and during surgeries to reduce clot formation. It is marketed under various brand names, with Calciparine being one of the well-known formulations.

Current Market Size and Key Players

The global anticoagulant market, including LMWHs, was valued at approximately USD 12.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.4% from 2023 to 2030 [1].

Major companies involved include:

  • Sanofi (Lovenox/Enoxaparin)
  • Pfizer (Fragmin/Dalteparin)
  • Macleods Pharmaceuticals
  • Baxter International
  • Cansino Biologics

Calciparine’s market share is smaller compared to leading brands like Enoxaparin but persists in specific regional markets due to its established presence and cost advantages.

Regulatory and Patent Landscape

Calciparine is mainly marketed in Europe, Latin America, and parts of Asia, with limited presence in North America due to regulatory barriers and patent expirations of competitors.

  • Patents: Most patents for Calciparine have expired or are nearing expiration in key markets, opening opportunities for generic formulations.
  • Regulatory Approvals: It holds approvals from the European Medicines Agency (EMA) and other regional agencies. Lack of FDA approval in the U.S. limits its market penetration.

Market Drivers

  1. Rising incidence of thromboembolic diseases: An aging global population and increased prevalence of cardiovascular diseases (CVDs) propel demand.
  2. Surgical procedures: Growth in orthopedic, cardiovascular, and oncological surgeries increases anticoagulant use.
  3. Cost sensitivity in emerging markets: Calciparine’s lower cost compared to branded LMWHs makes it attractive in price-sensitive regions.
  4. COVID-19 pandemic: Increased thrombosis cases linked to COVID-19 have temporarily raised the demand for anticoagulants.

Market Constraints

  • Regulatory hurdles: Approval processes are complex, particularly in North America.
  • Competition: Longer-established brands like Lovenox and Fragmin have dominant market shares and extensive marketing support.
  • Perception of efficacy and safety: Newer LMWHs and direct oral anticoagulants (DOACs) are perceived as safer or easier to manage, reducing demand for traditional formulations like Calciparine.
  • Generic competition: As patents expire, generic versions flood certain markets, pressuring prices.

Financial Trajectory and Investment Outlook

Revenue Projections

Calciparine’s revenue in 2022 was estimated at USD 150 million. With an expected CAGR of approximately 4-6% over the next five years, primarily driven by emerging markets and increased thrombotic events, revenues could reach USD 200 million–USD 250 million by 2028 [2].

Pricing and Margins

  • Pricing: Competitive in low- and middle-income regions, approximately USD 2–4 per dose.
  • Margins: Narrow margins due to generic competition and pricing pressure. Historically, gross margins range from 30-40%.

R&D and Expansion Potential

Limited R&D expenditures are typical for established, off-patent drugs. Yet, new formulations or delivery mechanisms (e.g., subcutaneous devices) could command premium pricing.

Investment Risks

  • Regulatory delays
  • Market entry of novel anticoagulants
  • Price erosion from generics

Regional Market Analysis

Region Market Size (2022 USD Million) CAGR (2023-2030) Key Factors
Europe 70 5.2% Mature market, high prescription volume
Latin America 30 6.8% Growing healthcare infrastructure
Asia-Pacific 40 7.1% Expanding hospitals, increasing CVD cases
North America 10 2.5% Limited due to regulatory hurdles

Strategic Opportunities

  • Regional expansion in Latin America and Asia-Pacific through targeted marketing.
  • Generic manufacturing to reduce costs and increase margins.
  • Partnerships with local healthcare providers.
  • Novel delivery systems to improve patient compliance.

Key Takeaways

  • Calciparine is an established, low-cost anticoagulant mainly used in emerging markets.
  • Global market size is growing, driven by aging populations and rising thrombotic disease incidence.
  • Patent expirations open opportunities for generics, increasing competition.
  • Revenue growth is moderate, with projections reaching USD 200–250 million by 2028.
  • Market constraints include regulatory challenges and competition from newer anticoagulants.

FAQs

1. What are the main competitors of Calciparine?
Lovenox (enoxaparin) and Fragmin (dalteparin) dominate the market, with significant brand loyalty and extensive clinical data.

2. How does regional regulation affect Calciparine's market?
Regulatory approvals are more accessible in Europe and Latin America but limited in North America, constraining market expansion.

3. Is Calciparine safer or less effective than newer anticoagulants?
Clinical data support comparable efficacy; however, newer agents like DOACs offer easier dosing and monitoring, influencing prescriber preferences.

4. What are the prospects for generic versions?
Patent expirations in key markets permit generic manufacturing, potentially reducing prices and increasing access.

5. How does COVID-19 impact demand for Calciparine?
Increased thrombotic risks linked with COVID-19 temporarily boosted demand, though long-term effects remain uncertain.


References:

[1] MarketWatch. (2023). Anticoagulant Market Size, Share & Trends Analysis.
[2] Research and Markets. (2023). Global Low Molecular Weight Heparins (LMWH) Market Forecast 2023-2030.

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