ADAMTS13, recombinant-krhn (ADZYNMA)
ADAMTS13, recombinant-krhn 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
2023
Reference approved
Reference product
ADZYNMA ADAMTS13, recombinant-krhn
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Nov 09, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ADAMTS13, recombinant-krhn, in chronological order.
Reference approval
Approval date of the reference ADAMTS13, recombinant-krhn product.
2 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 6 mo
Frequently asked questions
Are there biosimilars approved for ADAMTS13, recombinant-krhn (ADZYNMA)?
No 351(k) biosimilars or interchangeable biosimilars referencing ADAMTS13, recombinant-krhn are listed in the FDA Purple Book yet.
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