evinacumab-dgnb (Evkeeza)
evinacumab-dgnb is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
Evkeeza evinacumab-dgnb
Regeneron Pharmaceuticals, Inc.
- Approved
- Feb 11, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for evinacumab-dgnb, in chronological order.
Reference approval
Approval date of the reference evinacumab-dgnb product.
5 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 10 mo
Frequently asked questions
Are there biosimilars approved for evinacumab-dgnb (Evkeeza)?
No 351(k) biosimilars or interchangeable biosimilars referencing evinacumab-dgnb 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.