ropeginterferon alfa-2b-njft (Besremi)
ropeginterferon alfa-2b-njft is an FDA-licensed reference biologic from PharmaEssentia Corporation. 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
Besremi ropeginterferon alfa-2b-njft
PharmaEssentia Corporation
- Approved
- Nov 12, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ropeginterferon alfa-2b-njft, in chronological order.
Reference approval
Approval date of the reference ropeginterferon alfa-2b-njft product.
4 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 6 mo
Frequently asked questions
Are there biosimilars approved for ropeginterferon alfa-2b-njft (Besremi)?
No 351(k) biosimilars or interchangeable biosimilars referencing ropeginterferon alfa-2b-njft 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.