Exagamglogene autotemcel (Casgevy)
Exagamglogene autotemcel is an FDA-licensed reference biologic from Vertex Pharmaceuticals Inc. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
Casgevy Exagamglogene autotemcel
Vertex Pharmaceuticals Inc
- Approved
- Dec 08, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Exagamglogene autotemcel, in chronological order.
Reference approval
Approval date of the reference Exagamglogene autotemcel product.
2 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 8 mo
Frequently asked questions
Are there biosimilars approved for Exagamglogene autotemcel (Casgevy)?
No 351(k) biosimilars or interchangeable biosimilars referencing Exagamglogene autotemcel are listed in the FDA Purple Book yet.
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