Physiological Effect: Increased Coagulation Factor Activity

Drugs with Physiological Effect: Increased Coagulation Factor Activity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	RINGER'S IN PLASTIC CONTAINER	calcium chloride; potassium chloride; sodium chloride	INJECTABLE;INJECTION	020002-001	Apr 17, 1992	AP	RX	No	No
B Braun	RINGER'S IN PLASTIC CONTAINER	calcium chloride; potassium chloride; sodium chloride	SOLUTION;IRRIGATION	018156-001	Approved Prior to Jan 1, 1982	AT	RX	No	No
Baxter Hlthcare	RINGER'S IN PLASTIC CONTAINER	calcium chloride; potassium chloride; sodium chloride	SOLUTION;IRRIGATION	018495-001	Feb 19, 1982	AT	RX	No	No
Hospira	TPN ELECTROLYTES IN PLASTIC CONTAINER	calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride	INJECTABLE;INJECTION	018895-001	Jul 20, 1984		RX	Yes	Yes
Icu Medical Inc	RINGER'S IN PLASTIC CONTAINER	calcium chloride; potassium chloride; sodium chloride	INJECTABLE;INJECTION	018251-001	Approved Prior to Jan 1, 1982	AP	RX	No	No

Increased Coagulation Factor Activity Market Analysis and Financial Projection

The market for drugs enhancing coagulation factor activity is experiencing significant growth driven by rising prevalence of bleeding disorders and technological advancements, while the patent landscape reveals intense innovation and strategic extensions to maintain market exclusivity.

Market Dynamics

Growth Drivers

• Rising Hemophilia Prevalence: The global coagulation factor concentrates market is projected to reach $11.4B by 2027 (CAGR: 7.8%), driven by increasing hemophilia cases and prophylactic treatment adoption[2]. Factor VIII dominates demand due to hemophilia A, while recombinant technologies reduce infection risks[4][15].
• Emerging Markets: Asia-Pacific’s recombinant coagulation factors market grows fastest (CAGR: 10.3%), fueled by healthcare investments in India and China[4].
• Aging Populations: Higher rates of atrial fibrillation and thrombosis in aging demographics boost anticoagulation therapy demand, projected to reach $57.1B by 2031 (CAGR: 8.39%)[11].

Challenges

• High Treatment Costs: Factor VII treatments exceed $6.5B globally[15], with recombinant therapies costing significantly more than plasma-derived options[4].
• Patent Expirations: Major patents like Catalyst Biosciences’ Factor IX (CB 2679d/ISU304) face biosimilar competition post-expiry, prompting innovation races[6][14].

Regional Insights

• North America leads with 43.4% market share in recombinant factors, aided by advanced healthcare and R&D investment[4].
• Europe sees growth in procoagulant NASPs (non-anticoagulant sulfated polysaccharides), with Baxter International securing patents for hemorrhage control[12].

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Patent Landscape

Key Innovations

1. Extended Half-Life Formulations:

   • Modified Factor VIIa (US8765915B2): Albumin-linked variants improve stability and activity by 25%, extending therapeutic windows[18].
   • Recombinant Factor VIII (US10370430B2): Insertions in A-domains retain procoagulant efficacy while enabling novel delivery systems[10].

2. Novel Targets:

   • Procoagulant Platelet Inhibitors (US20170326096A1): Compounds selectively target platelets to enhance clot precision[9].
   • Bispecific Antibodies (T 0921/17): Chugai’s antibody mimics Factor VIII’s role in hemophilia A, though validity disputes highlight IP risks[17].

3. Synthetic Alternatives:

   • Tartrate Salts (US8394821B2): The (+)-tartrate monohydrate of FXa inhibitors improves solubility and stability versus traditional formulations[1].

Patent Trends

• Geographic Focus: 22.2% of coagulation-related patents originate in the U.S., followed by Europe (17.2%)[15].
• Strategic Filings: Companies prioritize:
  • Formulation Patents: 35% of recent filings cover extended-release or temperature-stable variants[4][12].
  • Biosimilar Defenses: High-confidence patents (e.g., EVARREST’s human coagulation factor claims) delay generics until 2030+[13].

Litigation and Validity Challenges

• Functional Claims: Courts increasingly invalidate broad antibody patents (e.g., Amgen’s PCSK9 litigation), emphasizing structural specificity[14].
• Assay Reproducibility: The European Patent Office revoked Chugai’s bispecific antibody patent due to inconsistent coagulation time measurements[17].

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Future Outlook

• AI-Driven Drug Discovery: Machine learning accelerates biomarker identification for personalized clotting therapies[5].
• Gene Therapy: CRISPR-edited Factor IX variants aim to reduce lifelong dependency on clotting factors[4].
• Market Consolidation: Top players (Baxter, Grifols, CSL Limited) invest $2.1B annually in coagulation R&D to dominate hemophilia and surgical hemostasis niches[2][12].

Highlight: “The (+)-tartrate monohydrate of FXa inhibitors represents a paradigm shift in bulk pharmaceutical stability.” — US8394821B2[1].

This sector remains a focal point for both therapeutic advancement and IP strategy, with innovation balancing cost pressures and unmet clinical needs in bleeding disorders.

References

1. https://patents.google.com/patent/US8394821B2/en
2. https://www.factmr.com/report/coagulation-factor-concentrates-market
3. https://patentpc.com/blog/patenting-innovations-anticoagulants-blood-thinner
4. https://www.meticulousresearch.com/product/recombinant-coagulation-factors-market-1254
5. https://royalsociety.org/-/media/policy/projects/science-in-the-age-of-ai/science-ai-related-inventions-report.pdf
6. https://www.clinicalleader.com/doc/catalyst-biosciences-receives-covering-hemostasis-complement-programs-0001
7. https://www.databridgemarketresearch.com/reports/global-coagulation-factor-vii-treatment-market
8. https://go.drugbank.com/drugs/DB13148
9. https://patents.google.com/patent/US20170326096A1/en
10. https://pubchem.ncbi.nlm.nih.gov/patent/US-10370430-B2
11. https://www.databridgemarketresearch.com/reports/global-anticoagulation-therapy-market
12. https://patents.justia.com/patents-by-us-classification/514/834
13. https://www.drugpatentwatch.com/p/biologics/tradename/EVARREST
14. https://www.spruson.com/app/uploads/2024/04/2023-Pharmaceutical-Patent-Review-Spruson-Ferguson-Lawyers.pdf
15. https://www.alliedmarketresearch.com/human-coagulation-factor-vii-market-A324440
16. https://www.transparencymarketresearch.com/thrombin-market.html
17. https://www.epo.org/en/boards-of-appeal/decisions/t170921eu1
18. https://patents.google.com/patent/US8765915B2/en