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: 2026-06-01
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
Product	Proprietary name	Proper name	License type	Strength	Dosage form	Route	Presentation	Marketing	Licensure	Approval	Patent list provided
001	OTARMENI	lunsotogene parvec-cwha	351(a)	3x10^13VG/ML	Suspension	Intracochlear	Single-Dose Vial	Rx	Licensed	2026-04-23

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.

Label, Manufacturer, Effective table
Label	Manufacturer	Effective
OTARMENI	Regeneron Pharmaceuticals, Inc. \| Brammer Bio MA, LLC \| Catalent Maryland, Inc. (BWI) \| BioReliance Corporation \| Charles River Laboratories, Inc. \| Nelson Laboratories, LLC \| Eurofins Lancaster Laboratories, LLC \| Primera Analytical Solutions Corporation \| Fisher BioServices, Inc. \| Fisher Clinical Services, Inc. \| Charles River Laboratories	2026-04-27

Official Monthly Change Events#

Release, Event, Product table
Release	Event	Product	Name	License type	Status	Applicant
2026-05-01	U	001	OTARMENI	351(a)	Rx	Regeneron Pharmaceuticals, Inc.
2026-04-01	N	001	OTARMENI	351(a)	Rx	Regeneron Pharmaceuticals, Inc.

Observed Product State History#

Release, Product, Name table
Release	Product	Name	License type	Marketing	Licensure	Approval
2026-04-01	001	OTARMENI	351(a)	Rx	Licensed	2026-04-23