Protein C Concentrate (Human) (Ceprotin)
Protein C Concentrate (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
2007
Reference approved
Reference product
Ceprotin Protein C Concentrate (Human)
Takeda Pharmaceuticals U.S.A., Inc.
- Approved
- Mar 30, 2007
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Protein C Concentrate (Human), in chronological order.
Reference approval
Approval date of the reference Protein C Concentrate (Human) product.
19 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
12 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for Protein C Concentrate (Human) (Ceprotin)?
No 351(k) biosimilars or interchangeable biosimilars referencing Protein C Concentrate (Human) are listed in the FDA Purple Book yet.
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