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.
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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