drug
eteplirsen
Marketedupdated 3mo agoby $SRPT Sarepta Therapeutics, Inc.
Approvedcommunity read0 votes
indications
investigational
Duchenne Muscular Dystrophy
all catalysts(0)
nothing on the calendar yet
Trials studying eteplirsen
- phase3A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)
- —A Long-term Observational Study Evaluating Eteplirsen, Golodirsen, or Casimersen in Routine Clinical Practice
- phase2Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Expansion (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment
- phase2A 48-Week, Open Label, Study to Evaluate the Efficacy and Safety of AMONDYS 45, EXONDYS 51, VYONDYS 53 in Subjects With DuchenneMuscular Dystrophy Carrying Eligible DMD Duplications.
- phase2A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Oct 27, 2028
~2.2 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (10)
- Mar 14, 2034method-of-use (U-1918)US 10337003
- Mar 14, 2034method-of-use (U-1918)US 10337003
- Mar 14, 2034method-of-use (U-1918)US 10364431
- Mar 14, 2034method-of-use (U-1918)US 10364431
- Mar 14, 2034method-of-use (U-1919)US 9506058
- Mar 14, 2034method-of-use (U-1919)US 9506058
- Feb 2, 2029formulationUS RE477692.5y
- Feb 2, 2029formulationUS RE477692.5y
- Oct 27, 2028method-of-use (U-2097)US RE484682.2y
- Oct 27, 2028method-of-use (U-2097)US RE484682.2y
News(1)
- Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ reviewIf approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…biospace · 24d ago
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