Purple Book reference family · 351(a) biologic
Coagulation Factor Xa (Recombinant), Inactivated-zhzo (Andexxa)
Coagulation Factor Xa (Recombinant), Inactivated-zhzo is an FDA-licensed reference biologic from AstraZeneca AB.
351(a) biologicBLA 125586 AstraZeneca AB
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2018
Reference product
Originator biologic
351(a)BLA 125586
Andexxa Coagulation Factor Xa (Recombinant), Inactivated-zhzo
AstraZeneca AB
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Coagulation Factor Xa (Recombinant), Inactivated-zhzo product.
8 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 5 mo ago
Coagulation Factor Xa (Recombinant), Inactivated-zhzo: 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 Xa (Recombinant), Inactivated-zhzo.
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