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FDA Purple Book · Reference family

anacaulase-bcdb (Nexobrid)

anacaulase-bcdb is an FDA-licensed reference biologic from Vericel Corporation. 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 761192

Nexobrid anacaulase-bcdb

Vericel Corporation

Approved
Dec 28, 2022
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for anacaulase-bcdb, in chronological order.

  1. Reference approval

    Approval date of the reference anacaulase-bcdb product.

    3 yr 6 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 5 yr 3 mo

Frequently asked questions

Are there biosimilars approved for anacaulase-bcdb (Nexobrid)?

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

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