Physiological Effect: Reversed Anticoagulation Activity

Drugs with Physiological Effect: Reversed Anticoagulation Activity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	214966-001	Jan 3, 2025	AB	RX	No	No
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

Reversed Anticoagulation Activity Market Analysis and Financial Projection

The market for anticoagulant reversal drugs is experiencing rapid growth driven by clinical demand and evolving therapeutic landscapes, while facing challenges from patent expirations and cost barriers. Below is a detailed analysis of its dynamics and intellectual property landscape:

Market Growth Drivers

• Projected Expansion: Valued at $1.38 billion in 2024, the market is expected to grow at a 12.35% CAGR, reaching $2.3–3.0 billion by 2030[1][5][16]. The aging population’s increased need for anticoagulation therapy (e.g., atrial fibrillation, venous thromboembolism) and rising surgical volumes are primary growth catalysts[1][5].
• Dominant Therapies:
  • Idarucizumab (Praxbind®) holds 36.8% market share (2024) due to its FDA-approved reversal of dabigatran[1][4].
  • Andexanet alfa (AndexXa®) is the fastest-growing segment (21.9% CAGR) for reversing factor Xa inhibitors like apixaban and rivaroxaban[1][7][15].
  • Regional demand: North America leads with ~45% market share (U.S. dominance via FDA approvals and aging demographics), while Asia-Pacific shows the fastest growth[4][14].

Cost and Access Challenges

• Pricing Disparities: Idarucizumab costs $3,482–6,965 per dose, whereas andexanet alfa historically cost $28,940 per treatment (pre-2020 price reductions)[4][8]. These prices limit adoption in lower-income countries[5][16].
• Health System Burdens: Hospitals account for >70% of distribution due to emergency care needs, but high costs strain budgets[4][14].

Patent Landscape and Generic Competition

• NOAC Expirations:	Drug	Primary Patent Expiry (LMICs)	Secondary Patents Until
  Dabigatran	2018	2024/25
  Rivaroxaban	2020	2026–2031
  Apixaban	2022	2026–2031

  Source [2] indicates generics face delays from formulation and method-of-use patents, particularly in emerging markets.

• Reversal Agent IP:

  • Idarucizumab’s composition patents expire in 2030–2032 (region-dependent)[2].
  • Andexanet alfa benefits from orphan drug exclusivity until 2026 in the U.S.[9].
  • Novel diagnostic patents (e.g., EP3611507B1 for ecarin-based coagulation assays) aim to extend lifecycle management[12].

Emerging Opportunities and Threats

• Pipeline Developments:
  • Ciraparantag: A universal reversal agent in late-stage trials for DOACs and heparins[2][9][15].
  • Biosimilars: Post-2030 generic entry could reduce costs by 30–50%[5][14].
• Regulatory Hurdles: Only 7/25 LMICs include NOACs in essential medicine lists due to cost-effectiveness concerns[2][16].

Key Strategic Considerations

• Market Entrants: Companies must navigate complex IP landscapes and prioritize regions with earlier patent expiries (e.g., India for dabigatran generics)[2].
• Partnerships: Collaborations with healthcare systems for education on reversal protocols could boost adoption[5][14].

“The annual cost of treating 10–20 patients with idarucizumab ranges from $34,825 to $69,650... hindering demand in underdeveloped countries.”[4]

In summary, the anticoagulant reversal market is bifurcated into high-cost, patented therapies in developed regions and access-constrained emerging markets. Patent cliffs post-2025 and pipeline innovations like ciraparantag will reshape competitive dynamics, while cost containment remains critical for sustainable growth.

References

1. https://www.grandviewresearch.com/industry-analysis/anticoagulant-reversal-drugs-market
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://atm.amegroups.org/article/view/28052/html
4. https://www.businesswire.com/news/home/20211130005556/en/Global-Anticoagulant-Reversal-Drugs-Market-Research-Report-2021-2027-Focus-on-Prothrombin-Complex-Concentrates-Phytonadione-andexanet-Alfa-Idarucizumab-Protamine---ResearchAndMarkets.com
5. https://www.360iresearch.com/library/intelligence/anticoagulant-reversal-drugs
6. https://www.businesswire.com/news/home/20200131005197/en/Global-Anticoagulant-Reversal-Drugs-Market-Report-2017-2025
7. https://www.isbtweb.org/isbt-working-parties/clinical-transfusion/resources/patient-blood-management-resources/16-anticoagulant-reversal.html
8. https://journals.sagepub.com/doi/abs/10.1177/10760296221110568
9. https://pmc.ncbi.nlm.nih.gov/articles/PMC6763385/
10. https://patents.google.com/patent/EP3611507B1/en
11. https://www.transparencymarketresearch.com/anticoagulant-reversal-drugs-market.html
12. https://patents.google.com/patent/EP3611507A1/en
13. https://pmc.ncbi.nlm.nih.gov/articles/PMC11084691/
14. https://www.factmr.com/report/4338/anticoagulant-reversal-drugs-market
15. https://www.mdpi.com/2305-6320/6/4/103
16. https://www.databridgemarketresearch.com/reports/global-anticoagulant-reversal-drugs-market