lunsotogene parvec-cwha (OTARMENI)
lunsotogene parvec-cwha is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2026
Reference approved
Reference product
OTARMENI lunsotogene parvec-cwha
Regeneron Pharmaceuticals, Inc.
- Approved
- Apr 23, 2026
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for lunsotogene parvec-cwha, in chronological order.
Reference approval
Approval date of the reference lunsotogene parvec-cwha product.
1 mo ago
Frequently asked questions
Are there biosimilars approved for lunsotogene parvec-cwha (OTARMENI)?
No 351(k) biosimilars or interchangeable biosimilars referencing lunsotogene parvec-cwha are listed in the FDA Purple Book yet.
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