Antithrombin (Recombinant) (Atryn)
Antithrombin (Recombinant) is an FDA-licensed reference biologic from rEVO Biologics, 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
Atryn Antithrombin (Recombinant)
rEVO Biologics, Inc.
- Approved
- Feb 06, 2009
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Antithrombin (Recombinant), in chronological order.
Reference approval
Approval date of the reference Antithrombin (Recombinant) product.
17 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
10 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for Antithrombin (Recombinant) (Atryn)?
No 351(k) biosimilars or interchangeable biosimilars referencing Antithrombin (Recombinant) are listed in the FDA Purple Book yet.
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