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Qfitlia · pharmadog

pharmadog
drugs
Qfitlia

drug

patient view →

fitusiran

Marketedupdated 2mo ago

by Genzyme Corp

Approved

community read0 votes

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Qfitlia

generic

fitusiran [INN]

indication

Hemophilia A (Factor VIII Deficiency)

phase

marketed

Data sources

ClinicalTrials.gov

last refreshed 1h ago

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no comments yet — first sniff?

Patent cliff

source: FDA Orange Book

first barrier falls

Mar 28, 2030

~3.7 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)3.7y
Mar 28, 2030NCENew Chemical Entity (5y)3.7y

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 Brecruitingn=85
phase3A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophiliaactive not recruitingn=91
phase3Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IXactive not recruitingn=281
phase4A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumabrecruitingn=20
phase3Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or Bactive not recruitingn=32
phase2An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or Bcompletedn=34