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COAGULATION FACTOR IX HUMAN
Coagulation Factor IX Human is a marketed drug used primarily in the treatment of hemophilia B, positioning it as a critical therapeutic option in the coagulation disorders market. The drug's key strength lies in its well-established safety and efficacy profile, supported by its current market presence and the protection of its key composition patent until 2028. The primary risk to the drug's market position is the upcoming patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | COAGULATION FACTOR IX HUMAN |
|---|---|
| Phase | FDA-approved |
| First approval | 2001 |
Approved indications
Common side effects
Key clinical trials
- HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients (PHASE3)
- A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B (PHASE1, PHASE2)
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
- Dosage and PD Study of Eftrenonacog-alfa
- An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B
- Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors (PHASE3)
- A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia (PHASE3)
- SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors (PHASE4)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- COAGULATION FACTOR IX HUMAN CI brief — competitive landscape report
- COAGULATION FACTOR IX HUMAN updates RSS · CI watch RSS