Alpha-1-Proteinase Inhibitor (Human) (Aralast, Aralast Np)
Alpha-1-Proteinase Inhibitor (Human) 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
2002
Reference approved
Reference product
Aralast, Aralast Np Alpha-1-Proteinase Inhibitor (Human)
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Dec 23, 2002
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Alpha-1-Proteinase Inhibitor (Human), in chronological order.
Reference approval
Approval date of the reference Alpha-1-Proteinase Inhibitor (Human) product.
23 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for Alpha-1-Proteinase Inhibitor (Human) (Aralast, Aralast Np)?
No 351(k) biosimilars or interchangeable biosimilars referencing Alpha-1-Proteinase Inhibitor (Human) are listed in the FDA Purple Book yet.
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