evolocumab (Repatha)
evolocumab is an FDA-licensed reference biologic from Amgen Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2016
Reference approved
Reference product
Repatha evolocumab
Amgen Inc.
- Approved
- Jul 08, 2016
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for evolocumab, in chronological order.
Reference approval
Approval date of the reference evolocumab product.
10 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 4 mo
Frequently asked questions
Are there biosimilars approved for evolocumab (Repatha)?
No 351(k) biosimilars or interchangeable biosimilars referencing evolocumab 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.