idarucizumab (Praxbind)
idarucizumab is an FDA-licensed reference biologic from Boehringer Ingelheim Pharmaceuticals, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Praxbind idarucizumab
Boehringer Ingelheim Pharmaceuticals, Inc.
- Approved
- Oct 16, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for idarucizumab, in chronological order.
Reference approval
Approval date of the reference idarucizumab product.
10 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
3 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for idarucizumab (Praxbind)?
No 351(k) biosimilars or interchangeable biosimilars referencing idarucizumab 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.