Coagulation Factor XIII A-Subunit (Recombinant) (Tretten)
Coagulation Factor XIII A-Subunit (Recombinant) is an FDA-licensed reference biologic from Novo Nordisk Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2013
Reference approved
Reference product
Tretten Coagulation Factor XIII A-Subunit (Recombinant)
Novo Nordisk Inc.
- Approved
- Dec 23, 2013
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor XIII A-Subunit (Recombinant), in chronological order.
Reference approval
Approval date of the reference Coagulation Factor XIII A-Subunit (Recombinant) product.
12 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
5 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for Coagulation Factor XIII A-Subunit (Recombinant) (Tretten)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor XIII A-Subunit (Recombinant) are listed in the FDA Purple Book yet.
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