epcoritamab-bysp (Epkinly)
epcoritamab-bysp is an FDA-licensed reference biologic from Genmab US, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
Epkinly epcoritamab-bysp
Genmab US, Inc.
- Approved
- May 19, 2023
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for epcoritamab-bysp, in chronological order.
Reference approval
Approval date of the reference epcoritamab-bysp product.
3 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 2 mo
Frequently asked questions
Are there biosimilars approved for epcoritamab-bysp (Epkinly)?
No 351(k) biosimilars or interchangeable biosimilars referencing epcoritamab-bysp 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.