Physiological Effect: Increased Prothrombin Activity

Drugs with Physiological Effect: Increased Prothrombin Activity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz Canada Inc	INFUVITE ADULT	alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k	SOLUTION;INTRAVENOUS	021163-001	May 18, 2000		RX	Yes	Yes
Sandoz Canada Inc	INFUVITE ADULT	alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k	SOLUTION;INTRAVENOUS	021163-002	Jun 16, 2003		RX	Yes	Yes
Sandoz Canada Inc	INFUVITE PEDIATRIC	ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k	INJECTABLE;INTRAVENOUS	021265-001	Feb 21, 2001		RX	Yes	Yes
Sandoz Canada Inc	INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)	ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k	INJECTABLE;INTRAVENOUS	021265-002	Jan 29, 2004		RX	Yes	Yes

Increased Prothrombin Activity Market Analysis and Financial Projection

The market dynamics and patent landscape for drugs influencing prothrombin activity reveal a rapidly evolving sector driven by clinical demand, technological innovation, and strategic intellectual property developments. Prothrombin complex concentrates (PCCs) dominate this space, with significant growth projected alongside advancements in recombinant production and therapeutic applications.

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Market Dynamics

Growth Projections and Demand Drivers

• The global PCC market is projected to rise from USD 772 million in 2023 to USD 1.2 billion by 2033, reflecting a 4.1% CAGR[1][6][11]. Key growth regions include the U.S., U.K., China, and India, where rising bleeding disorder prevalence and healthcare investments are accelerating demand[1][4].
• Major drivers include:
  • Increased warfarin reversal applications, which are 60–70% more cost-effective than alternative therapies like fresh frozen plasma[4][6].
  • Growing incidence of hemophilia (e.g., 450,000 cases in India) and congenital coagulation deficiencies[6][11].
  • Expansion of emergency medicine usage, particularly in trauma centers[6].

Regional Insights

• North America and Europe: Hold dominant market shares due to robust healthcare infrastructure and high adoption of advanced PCC formulations[4].
• Asia-Pacific: Emerging as a high-growth zone, driven by India’s large patient pool and China’s focus on healthcare modernization[1][6].

Innovation Trends

• Personalized Medicine: Development of tailored PCCs for genetic disorders and subtype-specific bleeding conditions[6][11].
• Delivery Systems: Subcutaneous and intranasal administration methods to improve patient compliance[6].
• Non-activated PCCs: New formulations minimizing thromboembolic risks while enhancing clotting efficacy[6][11].

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Patent Landscape

Production and Activation Methods

• Recombinant Prothrombin: Patents like WO2014115087A2 cover recombinant human prothrombin analogs (e.g., M400A) with reduced autolysis and improved fibrinogen cleavage activity, produced in human cell lines[5].
• Activation Processes: US5677162A details calcium-dependent cold incubation to activate prothrombin without animal-derived components, streamlining thrombin production[7].
• Venom-Derived Innovations: Q-Sera’s RAPClot™ technology uses prothrombin activators from snake venom, patented for blood collection tubes and scalable manufacturing[15].

Therapeutic Expansion

• Synergistic Combinations: US8394768B2 protects PCC-FVIII concentrate cocktails for treating severe bleeding, enhancing clotting factor synergy[12].
• Drug Repositioning: Secondary patents focus on new indications, such as reversing direct oral anticoagulants (DOACs)[6].

Challenges and Competition

• Patent Thickets: Overlapping claims on formulations and methods (e.g., ritonavir’s 800+ patent families) could delay generics[13][14]. However, PCC patents remain more focused on process innovation[5][7].
• Cost Barriers: High manufacturing costs for recombinant analogs drive efforts to optimize expression systems and purification[5].

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Strategic Implications

Future Opportunities

• Emerging Markets: India’s underpenetrated market offers potential, with investments in hemophilia clinics and diagnostics[6].
• Biosimilar Development: Patent expiries post-2031 may open doors for biosimilars in regions like Africa and Southeast Asia[14].

Regulatory and Access Considerations

• Cost-Effectiveness: PCCs reduce hospitalization durations by ~30% compared to plasma transfusions, aligning with value-based healthcare models[4][6].
• Equity Initiatives: Partnerships like the Medicines Patent Pool could widen access to PCC technologies in low-income countries[8].

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Key Takeaways

1. Market Growth: PCC demand will surge due to bleeding disorder prevalence and anticoagulant reversal needs.
2. Innovation Focus: Recombinant analogs and venom-derived activators redefine production and therapeutic efficacy.
3. Patent Strategy: Process patents dominate, but secondary claims on formulations and combinations create competitive moats.
4. Access Challenges: Balancing IP protection with affordability remains critical for global health equity.

References

1. https://www.pharmiweb.com/press-release/2025-02-06/global-prothrombin-complex-concentrates-market-set-for-significant-growth-projected-to-reach-usd-1
2. https://patents.google.com/patent/JPH11228443A/en
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC7309871/
4. https://www.globenewswire.com/news-release/2018/12/27/1678423/34408/en/Prothrombin-Complex-Concentrates-Market-is-Projected-to-Expand-at-a-CAGR-of-3-5-over-2018-2028-Future-Market-Insights.html
5. https://patents.google.com/patent/WO2014115087A2/en
6. https://www.futuremarketinsights.com/reports/prothrombin-complex-concentrate-market
7. https://patents.google.com/patent/US5677162A/en
8. https://www.treatmentactiongroup.org/wp-content/uploads/2021/11/hcv_tb_longacting_patent_trends.pdf
9. https://patents.google.com/patent/US5625036A/fr
10. https://www.jacc.org/doi/10.1016/S0735-1097(03)00416-9
11. https://www.pharmiweb.com/press-release/2024-10-14/global-prothrombin-complex-concentrates-market-poised-for-significant-growth-projected-to-reach-usd
12. https://patents.google.com/patent/US8394768B2/en
13. https://www.keionline.org/21711
14. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
15. https://brandoncapital.vc/2019/08/20/q-seras-innovative-blood-clotting-technology-granted-patent-in-us/