blinatumomab (Blincyto)
blinatumomab is an FDA-licensed reference biologic from Amgen Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2014
Reference approved
Reference product
Blincyto blinatumomab
Amgen Inc.
- Approved
- Dec 03, 2014
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for blinatumomab, in chronological order.
Reference approval
Approval date of the reference blinatumomab product.
11 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 1 mo
Frequently asked questions
Are there biosimilars approved for blinatumomab (Blincyto)?
No 351(k) biosimilars or interchangeable biosimilars referencing blinatumomab are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.