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FDA Purple Book · Reference family

crovalimab-akkz (Piasky)

crovalimab-akkz is an FDA-licensed reference biologic from Genentech, 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

351(a)BLA 761388

Piasky crovalimab-akkz

Genentech, Inc.

Approved
Jun 20, 2024
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for crovalimab-akkz, in chronological order.

  1. Reference approval

    Approval date of the reference crovalimab-akkz product.

    2 yr ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 5 yr 2 mo

Frequently asked questions

Are there biosimilars approved for crovalimab-akkz (Piasky)?

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

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