FDA.reportPublic FDA data

OTARMENI Purple Book BLA 125874

BLA number
125874
Proprietary names
OTARMENI
Proper names
lunsotogene parvec-cwha
Applicant
Regeneron Pharmaceuticals, Inc.
Center
CBER
First observed release
2026-04-01
Latest observed release
2026-08-01
Newest archive release
2026-08-01
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
001OTARMENIlunsotogene parvec-cwha351(a)3x10^13VG/MLSuspensionIntracochlearSingle-Dose VialRxLicensed2026-04-23

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
2026-05-01U001OTARMENI351(a)RxRegeneron Pharmaceuticals, Inc.
2026-04-01N001OTARMENI351(a)RxRegeneron Pharmaceuticals, Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2026-04-01001OTARMENI351(a)RxLicensed2026-04-23