Coagulation Factor X (Human) (Coagadex)
Coagulation Factor X (Human) is an FDA-licensed reference biologic from Bio Products Laboratory Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Coagadex Coagulation Factor X (Human)
Bio Products Laboratory Limited
- Approved
- Oct 20, 2015
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor X (Human), in chronological order.
Reference approval
Approval date of the reference Coagulation Factor X (Human) product.
10 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 11 mo
Frequently asked questions
Are there biosimilars approved for Coagulation Factor X (Human) (Coagadex)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor X (Human) are listed in the FDA Purple Book yet.
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