Lifileucel (AMTAGVI)
Lifileucel is an FDA-licensed reference biologic from Iovance Biotherapeutics, Inc..
Reference product
AMTAGVI Lifileucel
Iovance Biotherapeutics, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
First licensure
Date Lifileucel was first licensed by the FDA.
2 yr 8 mo ago
Reference approval
Approval date of the reference Lifileucel product.
2 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 6 mo
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 9 yr 6 mo
Lifileucel: 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 Lifileucel.
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.
