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Exondys 51 · pharmadog

pharmadog
drugs
Exondys 51

drug

patient view →

eteplirsen

Marketedupdated 2mo ago

by $SRPT Sarepta Therapeutics, Inc.

Approved

community read0 votes

indications

investigational

Duchenne Muscular Dystrophy

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Exondys 51

generic

eteplirsen

indication

Duchenne Muscular Dystrophy

phase

marketed

Data sources

ClinicalTrials.gov

last refreshed 31m ago

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no comments yet — first sniff?

Patent cliff

source: FDA Orange Book

first barrier falls

Oct 27, 2028

~2.3 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 RE477692.6y
Feb 2, 2029formulationUS RE477692.6y
Oct 27, 2028method-of-use (U-2097)US RE484682.3y
Oct 27, 2028method-of-use (U-2097)US RE484682.3y

Trials studying eteplirsen

phase3A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)active not recruitingn=160
—A Long-term Observational Study Evaluating Eteplirsen, Golodirsen, or Casimersen in Routine Clinical Practiceenrolling by invitationn=300
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 Treatmentterminatedn=62
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.completedn=3
phase2A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)terminatedn=15