drug
fitusiran
Marketedupdated 3mo agoby Genzyme Corp
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying fitusiran
- phase3A 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
- phase3A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
- phase3Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX
- phase4A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab
- phase3Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B
- phase2An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 28, 2030
~3.6 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (6)
- Dec 7, 2036method-of-use (U-4165)US 11091759
- Dec 7, 2036method-of-use (U-4165)US 11091759
- Mar 22, 2033compositionUS 9127274
- Mar 22, 2033compositionUS 9127274
- Mar 15, 2033compositionUS 9376680
- Mar 15, 2033compositionUS 9376680
FDA exclusivities (6)
- Mar 28, 2032ODE-510Orphan Drug (7y)
- Mar 28, 2032ODE-511Orphan Drug (7y)
- Mar 28, 2032ODE-510Orphan Drug (7y)
- Mar 28, 2032ODE-511Orphan Drug (7y)
- Mar 28, 2030NCENew Chemical Entity (5y)3.6y
- Mar 28, 2030NCENew Chemical Entity (5y)3.6y
News(1)
- After tasting IPO success, Hemab’s CEO seeks ‘flavor of a multi-product coagulation company’With the post-IPO quiet period having come to an end, CEO Benny Sørensen, M.D., Ph.D., was free to sit down with Fierce to map out Hemab’s future.fiercebiotech · 9d ago
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