Factor VIII Activator Drug Class List

Drugs in Drug Class: Factor VIII Activator

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938-001	Mar 30, 1984	AP	RX	Yes	Yes
Ferring Pharms Inc	DDAVP	desmopressin acetate	INJECTABLE;INJECTION	018938-002	Apr 25, 1995		DISCN	No	No
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-001	Sep 6, 1995	AB	RX	Yes	No
Ferring Pharms Inc	DDAVP	desmopressin acetate	TABLET;ORAL	019955-002	Sep 6, 1995	AB	RX	Yes	Yes
Sagent Pharms Inc	DESMOPRESSIN ACETATE	desmopressin acetate	INJECTABLE;INJECTION	204695-001	Aug 22, 2017	AP	RX	No	No

Factor VIII Activator Market Analysis and Financial Projection

The global market for Factor VIII activators is experiencing significant growth driven by advancements in recombinant technologies, novel drug formulations, and expanding applications in bleeding disorders. Here's an in-depth analysis of the market dynamics and patent landscape:

Market Dynamics

Current Market Valuation

• The plasma-derived Factor VIII market was valued at $8.76 billion in 2023, projected to reach $12.95 billion by 2030 (CAGR: 5.7%) [1].
• Desmopressin, a synthetic Factor VIII activator, held a market size of $1.13 billion in 2023, expected to grow to $1.65–2.0 billion by 2030 (CAGR: 5.3–5.8%) [14][15][18].

Key Growth Drivers

1. Rising Prevalence of Hemophilia A: Over 80% of hemophilia cases are linked to Factor VIII deficiency [5][7].
2. Innovative Therapies: Bispecific antibodies (e.g., Mim8, emicizumab) mimic Factor VIII’s cofactor activity, offering prophylaxis for hemophilia A patients with inhibitors [9][10].
3. Pediatric Formulations: New oral solutions like Eton Pharma’s ET-600 (patented until 2044) address unmet needs in pediatric dosing precision [17][19].

Competitive Landscape

• Plasma-derived Products: Dominated by Takeda, Grifols, and CSL [1][5].
• Recombinant Innovations: Companies like Bioverativ (patent US11261234) focus on mutant Factor VIII proteins with enhanced stability and reduced immunogenicity [8].
• Generics/Biosimilars: Desmopressin’s key patent expired in 2023, opening opportunities for generics, while novel formulations retain exclusivity [16][17].

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Patent Landscape

Recent Innovations

1. Recombinant Factor VIII Modifications

   • US-10370430-B2 (2019): Covers recombinant Factor VIII with inserted heterologous moieties in A domains to retain procoagulant activity [2].
   • US11261234 (2022): Mutant Factor VIII compositions with amino acid substitutions (e.g., I86, Y105) to boost expression/secretion [8].

2. Bispecific Antibodies

   • Mim8 (Novo Nordisk) and NXT007 (Chugai) bypass Factor VIII inhibitors by bridging Factor IXa and Factor X, mimicking Factor VIII’s role [10].

3. Delivery Systems

   • ET-600: An oral desmopressin solution (US Patent 12,214,010) for pediatric diabetes insipidus, extending market exclusivity to 2044 [17][19].

Strategic Trends

• Targeted Therapies: Over 50% of recent patents focus on enhancing Factor VIII’s half-life and reducing immunogenicity [6][8].
• Collaborations: Partnerships between Pharma giants (e.g., Sanofi-Ardelyx) drive patent clustering around coagulation targets like DAO and RET [6].
• Geographic Expansion: Asia-Pacific markets are growing at 8.5% CAGR for desmopressin, outpacing North America and Europe [15].

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Emerging Challenges

• Cost Constraints: High prices of recombinant therapies limit accessibility in developing regions [5].
• Inhibitor Development: ~30% of severe hemophilia A patients develop anti-Factor VIII antibodies, necessitating alternative therapies [10].
• Regulatory Hurdles: Complex approval pathways for biosimilars delay market entry despite patent expirations [16].

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Future Outlook

The Factor VIII activator market is pivoting toward personalized medicine, with gene therapies and next-gen biologics in clinical pipelines [3][10]. Patent analytics indicate a surge in CRISPR-based Factor VIII gene editing (not yet reflected in current data), which could revolutionize treatment paradigms. Meanwhile, strategic acquisitions and Orange Book listings (e.g., ET-600) will shape competitive dynamics through 2040.

"The pediatric endocrinology community has expressed the significant need for a liquid form of desmopressin that can accurately and efficiently deliver small doses for children." – Sean Brynjelsen, CEO of Eton Pharmaceuticals [17].

References

1. https://reports.valuates.com/market-reports/QYRE-Auto-39D12137/global-plasma-derived-factor
2. https://pubchem.ncbi.nlm.nih.gov/patent/US-10370430-B2
3. https://www.globaldata.com/store/report/coagulation-factor-viii-drugs-in-development-and-analysis/
4. https://go.drugbank.com/drugs/DB13192
5. https://en.wikipedia.org/wiki/Factor_VIII_(medication)
6. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3.full-text
7. https://en.wikipedia.org/wiki/Factor_VIII
8. https://patents.justia.com/patent/11261234
9. https://news.mayocliniclabs.com/2019/03/28/chromogenic-factor-viii-and-ix-assays-impact-on-diagnosis-and-management-of-hemophilia/
10. https://journals.viamedica.pl/journal_of_transfusion_medicine/article/download/99303/76312
11. https://onlinelibrary.wiley.com/doi/abs/10.1002/ajh.2830160312
12. https://drugcentral.org/drugcard/817
13. https://fda.report/NDC/60505-0258
14. https://www.databridgemarketresearch.com/reports/global-desmopressin-market
15. https://www.marketresearch.com/Global-Industry-Analysts-v1039/Desmopressin-38689708/
16. https://pharsight.greyb.com/drug/desmopressin-acetate-patent-expiration
17. https://www.pharmaceutical-technology.com/news/eton-patent-diabetes-insipidus/
18. https://www.verifiedmarketresearch.com/product/desmopressin-market/
19. https://www.pharmabiz.com/NewsDetails.aspx?aid=175186&sid=2