Purple Book reference family · 351(a) biologic
ecallantide (Kalbitor)
ecallantide is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc..
351(a) biologicBLA 125277 Takeda Pharmaceuticals U.S.A., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2009
Reference product
Originator biologic
351(a)BLA 125277
Kalbitor ecallantide
Takeda Pharmaceuticals U.S.A., 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 ecallantide product.
17 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 7 mo ago
ecallantide: 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 ecallantide.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
