Coagulation Factor Xa (Recombinant), Inactivated-zhzo (Andexxa)
Coagulation Factor Xa (Recombinant), Inactivated-zhzo is an FDA-licensed reference biologic from AstraZeneca AB. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
Andexxa Coagulation Factor Xa (Recombinant), Inactivated-zhzo
AstraZeneca AB
- Approved
- May 03, 2018
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Coagulation Factor Xa (Recombinant), Inactivated-zhzo, in chronological order.
Reference approval
Approval date of the reference Coagulation Factor Xa (Recombinant), Inactivated-zhzo product.
8 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for Coagulation Factor Xa (Recombinant), Inactivated-zhzo (Andexxa)?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagulation Factor Xa (Recombinant), Inactivated-zhzo are listed in the FDA Purple Book yet.
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