Purple Book reference family · 351(a) biologic
tebentafusp-tebn (Kimmtrak)
tebentafusp-tebn is an FDA-licensed reference biologic from Immunocore Limited.
351(a) biologicBLA 761228 Immunocore Limited
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2022
Reference product
Originator biologic
351(a)BLA 761228
Kimmtrak tebentafusp-tebn
Immunocore Limited
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference tebentafusp-tebn product.
4 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 5 mo
tebentafusp-tebn: 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 tebentafusp-tebn.
Related FDA reference tools
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- 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.
