Antithrombin III (Human) (Thrombate Iii)
Antithrombin III (Human) is an FDA-licensed reference biologic from Grifols Therapeutics LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1991
Reference approved
Reference product
Thrombate Iii Antithrombin III (Human)
Grifols Therapeutics LLC
- Approved
- Dec 30, 1991
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Antithrombin III (Human), in chronological order.
Reference approval
Approval date of the reference Antithrombin III (Human) product.
34 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
27 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for Antithrombin III (Human) (Thrombate Iii)?
No 351(k) biosimilars or interchangeable biosimilars referencing Antithrombin III (Human) are listed in the FDA Purple Book yet.
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