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human coagulation Factor IX
Human coagulation Factor IX, marketed by Prothya Biosolutions, is an established treatment in the hemophilia B market. The drug's key composition patent is set to expire in 2028, providing a period of exclusivity that supports its market position. However, the lack of disclosed revenue and primary trial results poses a significant risk in assessing its competitive landscape and long-term viability.
At a glance
| Generic name | human coagulation Factor IX |
|---|---|
| Also known as | Nonafact |
| Sponsor | Prothya Biosolutions |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients (PHASE3)
- Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B (PHASE2)
- SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors (PHASE4)
- Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery (PHASE4)
- Treatment of Hemophilia A Patients With FVIII Inhibitors
- Study of AAV5-hFIX in Severe or Moderately Severe Haemophilia B
- Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (PHASE3)
- A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- human coagulation Factor IX CI brief — competitive landscape report
- human coagulation Factor IX updates RSS · CI watch RSS
- Prothya Biosolutions portfolio CI