axatilimab-csfr (Niktimvo)
axatilimab-csfr is an FDA-licensed reference biologic from Incyte Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
Niktimvo axatilimab-csfr
Incyte Corporation
- Approved
- Aug 14, 2024
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for axatilimab-csfr, in chronological order.
Reference approval
Approval date of the reference axatilimab-csfr product.
1 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 3 mo
Frequently asked questions
Are there biosimilars approved for axatilimab-csfr (Niktimvo)?
No 351(k) biosimilars or interchangeable biosimilars referencing axatilimab-csfr 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.