pegademase bovine (Adagen)
pegademase bovine is an FDA-licensed reference biologic from Leadiant Biosciences, Inc. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1990
Reference approved
Reference product
Adagen pegademase bovine
Leadiant Biosciences, Inc
- Approved
- Mar 21, 1990
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pegademase bovine, in chronological order.
Reference approval
Approval date of the reference pegademase bovine product.
36 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
29 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for pegademase bovine (Adagen)?
No 351(k) biosimilars or interchangeable biosimilars referencing pegademase bovine are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.