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FDA Purple Book · Reference family

tebentafusp-tebn (Kimmtrak)

tebentafusp-tebn is an FDA-licensed reference biologic from Immunocore Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2022

Reference approved

Reference product

351(a)BLA 761228

Kimmtrak tebentafusp-tebn

Immunocore Limited

Approved
Jan 25, 2022
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for tebentafusp-tebn, in chronological order.

  1. Reference approval

    Approval date of the reference tebentafusp-tebn product.

    4 yr 5 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 2 yr 8 mo

Frequently asked questions

Are there biosimilars approved for tebentafusp-tebn (Kimmtrak)?

No 351(k) biosimilars or interchangeable biosimilars referencing tebentafusp-tebn are listed in the FDA Purple Book yet.

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