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Last Updated: July 28, 2025

Warfarin Reversal Agent Drug Class List


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Drugs in Drug Class: Warfarin Reversal Agent

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Cipla PHYTONADIONE phytonadione INJECTABLE;INJECTION 214966-001 Jan 3, 2025 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087954-001 Jul 25, 1983 BP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087955-001 Jul 25, 1983 AB1 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Zydus Lifesciences PHYTONADIONE phytonadione TABLET;ORAL 210189-001 Feb 20, 2019 AB RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Warfarin Reversal Agent Market Analysis and Financial Projection

Last updated: July 27, 2025

The market for warfarin reversal agents is experiencing significant growth driven by clinical demand and innovation, while the patent landscape reflects both expiring protections and emerging therapies. Here's a detailed analysis:


Market Dynamics

  1. Growth Projections and Drivers

    • The global anticoagulant reversal drugs market, valued at $923.2 million in 2022, is projected to grow at a CAGR of 11.3%, reaching $2.3 billion by 2031[1][10]. This growth is fueled by:
      • Rising use of anticoagulants (e.g., warfarin) for conditions like atrial fibrillation and venous thromboembolism.
      • Aging populations prone to bleeding complications[1][6].
      • Increasing surgical procedures and trauma cases requiring urgent reversal[4][5].
  2. Key Product Segments

    • Vitamin K: Dominates the market due to its low cost and widespread use for warfarin reversal[1][10].
    • Prothrombin Complex Concentrates (4F-PCC): Agents like Kcentra (approved in 2013) and Balfaxar (approved in 2024) are critical for rapid warfarin reversal in emergencies[3][14].
    • Idarucizumab: Specifically targets dabigatran but influences broader reversal protocols[7][13].
  3. Regional Dominance

    • North America holds the largest market share (39.62% in 2019), driven by high healthcare spending, favorable reimbursement policies, and rapid access to reversal agents[5][6]. The U.S. market alone was valued at $457.6 million in 2024[6].
    • Asia-Pacific is the fastest-growing region, attributed to improving healthcare infrastructure and rising anticoagulant adoption[5][6].
  4. Distribution Channels

    • Hospital pharmacies account for over 51% of sales due to the urgent need for reversal agents in clinical settings[6][10].

Patent Landscape

  1. Expiring Patents and Generic Competition

    • Warfarin dosage prediction patents (e.g., US20070298426A1) leverage genetic testing (CYP2C9/VKORC1) to optimize dosing, reducing bleeding risks[8].
    • Novel reversal agents:
      • Andexanet alfa (Andexxa®) and idarucizumab (Praxbind®) are protected by patents, but secondary patents for DOACs like dabigatran expire by 2024–2025, potentially delaying generics[2][12].
      • Factor Xa inhibitor reversal agents (e.g., WO2012043577A1) and broad-spectrum compounds (WO2013082210A1) highlight ongoing R&D[9][11].
  2. Impact of Patent Expirations

    • Drugs like Eliquis (apixaban) and Xarelto (rivaroxaban) face patent expirations in 2025–2026, which may shift focus to newer reversal agents[12].
    • Biosimilars and generics: Post-2025, cheaper alternatives could reduce costs but may lag in LMICs due to infrastructure challenges[2][12].
  3. Regulatory and Clinical Advancements

    • The FDA’s approval of Balfaxar (2024) underscores the push for safer, faster-acting agents[14].
    • Guidelines increasingly favor 4F-PCC over plasma for warfarin reversal, though dosing practices vary[7][13].

Future Outlook

  • Innovation: Development of universal reversal agents (e.g., ciraparantag) and gene-based dosing tools could reshape treatment paradigms[9][13].
  • Market Expansion: Emerging markets in Asia and Latin America offer growth opportunities as anticoagulant use rises[5][6].
  • Cost Pressures: Patent expirations and biosimilars may lower prices, improving access but challenging profitability[2][12].

The warfarin reversal market remains dynamic, balancing clinical needs with evolving intellectual property and cost considerations.

References

  1. https://www.globenewswire.com/de/news-release/2023/10/17/2761217/0/en/Anticoagulant-Reversal-Drugs-Market-Revenue-to-Cross-USD-2-3-billion-by-2031-Expanding-at-a-CAGR-of-11-3-Exclusive-Report-by-Transparency-Market-Research.html
  2. https://medicinespatentpool.org/uploads/2020/04/Chapter-5-Patented-medicines-that-have-clinical-benefits-but-did-not-meet-the-EML-Expert-Review-committee%E2%80%99s-comparative-cost-effectiveness-criterion-Case-study-on-novel-oral-anticoagulants.pdf
  3. https://www.dicardiology.com/content/fda-approves-kcentra-use-warfarin-reversal-patients-undergoing-surgery
  4. https://www.globenewswire.com/news-release/2022/11/07/2549814/0/en/North-America-to-dominate-the-Global-Anticoagulant-Reversal-Drugs-Industry-with-a-CAGR-of-14-8-by-2032-Fact-MR-Report.html
  5. https://straitsresearch.com/report/anticoagulant-reversal-drugs-market
  6. https://www.gminsights.com/industry-analysis/anticoagulant-reversal-drugs-market
  7. https://pmc.ncbi.nlm.nih.gov/articles/PMC10259145/
  8. https://patents.google.com/patent/US20070298426
  9. https://patents.google.com/patent/WO2012043577A1/en
  10. https://www.transparencymarketresearch.com/anticoagulant-reversal-drugs-market.html
  11. https://patents.google.com/patent/WO2013082210A1/en
  12. https://biopharmaapac.com/analysis/60/5727/25-high-value-drugs-losing-patent-protection-in-2025-what-it-means-for-healthcare.html
  13. https://www.emdocs.net/reversal-of-anticoagulation/
  14. https://secure.medicalletter.org/TML-article-1696d

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