Lifileucel (AMTAGVI)
Lifileucel is an FDA-licensed reference biologic from Iovance Biotherapeutics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
AMTAGVI Lifileucel
Iovance Biotherapeutics, Inc.
- Approved
- Feb 16, 2024
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Lifileucel, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
96 yr 10 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
91 yr 9 mo ago
First licensure
Date Lifileucel was first licensed by the FDA.
2 yr 5 mo ago
Reference approval
Approval date of the reference Lifileucel product.
2 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for Lifileucel (AMTAGVI)?
No 351(k) biosimilars or interchangeable biosimilars referencing Lifileucel are listed in the FDA Purple Book yet.
When does Lifileucel (AMTAGVI) lose reference-product exclusivity?
Lifileucel's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending February 16, 1936.
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.