revakinagene taroretcel-lwey (encelto)
revakinagene taroretcel-lwey is an FDA-licensed reference biologic from Neurotech Pharmaceuticals Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2025
Reference approved
Reference product
encelto revakinagene taroretcel-lwey
Neurotech Pharmaceuticals Inc.
- Approved
- Mar 05, 2025
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for revakinagene taroretcel-lwey, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
90 yr 8 mo ago
First licensure
Date revakinagene taroretcel-lwey was first licensed by the FDA.
1 yr 5 mo ago
Reference approval
Approval date of the reference revakinagene taroretcel-lwey product.
1 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for revakinagene taroretcel-lwey (encelto)?
No 351(k) biosimilars or interchangeable biosimilars referencing revakinagene taroretcel-lwey are listed in the FDA Purple Book yet.
When does revakinagene taroretcel-lwey (encelto) lose reference-product exclusivity?
revakinagene taroretcel-lwey's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending March 5, 1937.
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.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.