Purple Book product · Reference 351(a)
OTARMENI
lunsotogene parvec-cwha
Apr 23, 2026
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 23, 1933
94 yr 7 mo ago
Approval
Approval date of this BLA submission.
Apr 23, 2026
3 mo ago
Today
Pharmaceutical detail
Strength
3x10^13VG/ML
Dosage form
Suspension
Route
Intracochlear
Presentation
Single-Dose Vial
Center
CBER
License number
1760
Product number
001
Submission type
Original
Supplement number
0
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does OTARMENI have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing OTARMENI are listed in the FDA Purple Book yet.
What is OTARMENI's BLA number?
OTARMENI is licensed under BLA 125874, held by Regeneron Pharmaceuticals, Inc..
When was OTARMENI approved by the FDA?
OTARMENI was approved by the FDA on Apr 23, 2026.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
