Purple Book reference family · 351(a) biologic
idarucizumab (Praxbind)
idarucizumab is an FDA-licensed reference biologic from Boehringer Ingelheim Pharmaceuticals, Inc..
351(a) biologicBLA 761025 Boehringer Ingelheim Pharmaceuticals, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2015
Reference product
Originator biologic
351(a)BLA 761025
Praxbind idarucizumab
Boehringer Ingelheim Pharmaceuticals, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference idarucizumab product.
11 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
4 yr ago
idarucizumab: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for idarucizumab.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
