ecallantide (Kalbitor)
ecallantide is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2009
Reference approved
Reference product
Kalbitor ecallantide
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Dec 01, 2009
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ecallantide, in chronological order.
Reference approval
Approval date of the reference ecallantide product.
16 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for ecallantide (Kalbitor)?
No 351(k) biosimilars or interchangeable biosimilars referencing ecallantide are listed in the FDA Purple Book yet.
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