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FVIII concentrate
FVIII concentrate, marketed by Federico II University, holds a position in the treatment landscape for hemophilia A, though specific revenue figures are not provided. The drug's key composition patent is set to expire in 2028, which may currently serve as a barrier to generic competition. The primary risk lies in the potential increase in market competition following the patent expiry.
At a glance
| Generic name | FVIII concentrate |
|---|---|
| Sponsor | Federico II University |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B (PHASE3)
- An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
- Post Approval Observational Study to Learn More About How Safe Octocog Alfa is and How Well it Works in Patients With Severe Hemophilia A in India
- Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age (PHASE3)
- SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis (PHASE3)
- PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A） (PHASE4)
- 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)
- A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab (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 |
|---|---|
| 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:
- FVIII concentrate CI brief — competitive landscape report
- FVIII concentrate updates RSS · CI watch RSS
- Federico II University portfolio CI