afamitresgene autoleucel (tecelra)
afamitresgene autoleucel is an FDA-licensed reference biologic from USWM CT, LLC.
Reference product
tecelra afamitresgene autoleucel
USWM CT, LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
First licensure
Date afamitresgene autoleucel was first licensed by the FDA.
2 yr 3 mo ago
Reference approval
Approval date of the reference afamitresgene autoleucel product.
4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 11 mo
afamitresgene autoleucel: 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 afamitresgene autoleucel.
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.
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