Purple Book reference family · 351(a) biologic
Coagulation Factor X (Human) (Coagadex)
Coagulation Factor X (Human) is an FDA-licensed reference biologic from Bio Products Laboratory Limited.
351(a) biologicBLA 125506 Bio Products Laboratory Limited
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2015
Reference product
Originator biologic
351(a)BLA 125506
Coagadex Coagulation Factor X (Human)
Bio Products Laboratory Limited
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Coagulation Factor X (Human) product.
11 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 7 mo
Coagulation Factor X (Human): frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Coagulation Factor X (Human).
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
