aprotinin (Trasylol)
aprotinin is an FDA-licensed reference biologic from Bayer HealthCare Pharmaceuticals Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1993
Reference approved
Reference product
Trasylol aprotinin
Bayer HealthCare Pharmaceuticals Inc.
- Approved
- Dec 29, 1993
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for aprotinin from the RCSB Protein Data Bank (PDB 1BPI).
Interactive biological assembly from PDB entry 1BPI. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for aprotinin, in chronological order.
Reference approval
Approval date of the reference aprotinin product.
33 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
25 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for aprotinin (Trasylol)?
No 351(k) biosimilars or interchangeable biosimilars referencing aprotinin are listed in the FDA Purple Book yet.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.