Purple Book reference family · 351(a) biologic
lunsotogene parvec-cwha (OTARMENI)
lunsotogene parvec-cwha is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc..
351(a) biologicBLA 125874 Regeneron Pharmaceuticals, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 125874
OTARMENI lunsotogene parvec-cwha
Regeneron Pharmaceuticals, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
94 yr 7 mo ago
Reference approval
Approval date of the reference lunsotogene parvec-cwha product.
3 mo ago
lunsotogene parvec-cwha: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for lunsotogene parvec-cwha.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
