FDA.reportPublic FDA data

ELEVIDYS Purple Book BLA 125781

BLA number
125781
Proprietary names
ELEVIDYS
Proper names
delandistrogene moxeparvovec-rokl
Applicant
Sarepta Therapeutics, Inc.
Center
CBER
First observed release
2023-06-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001ELEVIDYSdelandistrogene moxeparvovec-rokl351(a)1.33 ×10E14 vector genomes (vg)/kg/bodyweight(bw)SuspensionIntravenousSingle-Dose VialRxLicensed2023-06-22

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2024-07-01U001ELEVIDYS351(a)RxSarepta Therapeutics, Inc.
2023-10-01U001ELEVIDYS351(a)RxSarepta Therapeutics, Inc.
2023-09-01U001ELEVIDYS351(a)RxSarepta Therapeutics, Inc.
2023-07-01U001ELEVIDYS351(a)RxSarepta Therapeutics, Inc.
2023-06-01N001ELEVIDYS351(a)RxSarepta Therapeutics, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2023-06-01001ELEVIDYS351(a)RxLicensed2023-06-22