Purple Book reference family · 351(a) biologic
desirudin (Iprivask)
desirudin is an FDA-licensed reference biologic from Bausch Health US, LLC.
351(a) biologicBLA 021271 Bausch Health US, LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2003
Reference product
Originator biologic
351(a)BLA 021271
Iprivask desirudin
Bausch Health US, LLC
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
RCSB Protein Data Bank
Experimental 3D structure for desirudin from the RCSB Protein Data Bank (PDB 2HIR).
Interactive biological assembly from PDB entry 2HIR. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference desirudin product.
23 yr 10 mo ago
desirudin: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for desirudin.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
