Purple Book reference family · 351(a) biologic
ADAMTS13, recombinant-krhn (ADZYNMA)
ADAMTS13, recombinant-krhn is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc..
351(a) biologicBLA 125795 Takeda Pharmaceuticals U.S.A., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 125795
ADZYNMA ADAMTS13, recombinant-krhn
Takeda Pharmaceuticals U.S.A., Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference ADAMTS13, recombinant-krhn product.
2 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 2 mo
ADAMTS13, recombinant-krhn: 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 ADAMTS13, recombinant-krhn.
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