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FDA Purple Book · Reference family

desirudin (Iprivask)

desirudin is an FDA-licensed reference biologic from Bausch Health US, LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2003

Reference approved

Reference product

351(a)BLA 021271

Iprivask desirudin

Bausch Health US, LLC

Approved
Apr 04, 2003
Marketing
Disc
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference desirudin product.

    23 yr 6 mo ago

Frequently asked questions

Are there biosimilars approved for desirudin (Iprivask)?

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

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