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
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for aprotinin, in chronological order.
Reference approval
Approval date of the reference aprotinin product.
32 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
25 yr 10 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.
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