tafasitamab-cxix (Monjuvi)
tafasitamab-cxix 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
2020
Reference approved
Reference product
Monjuvi tafasitamab-cxix
Incyte Corporation
- Approved
- Jul 31, 2020
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tafasitamab-cxix, in chronological order.
Reference approval
Approval date of the reference tafasitamab-cxix product.
5 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 2 mo
Frequently asked questions
Are there biosimilars approved for tafasitamab-cxix (Monjuvi)?
No 351(k) biosimilars or interchangeable biosimilars referencing tafasitamab-cxix 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.