Purple Book reference family · 351(a) biologic
Exagamglogene autotemcel (Casgevy)
Exagamglogene autotemcel is an FDA-licensed reference biologic from Vertex Pharmaceuticals Inc.
351(a) biologicBLA 125787 Vertex Pharmaceuticals Inc
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 125787
Casgevy Exagamglogene autotemcel
Vertex Pharmaceuticals Inc
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 Exagamglogene autotemcel product.
2 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 5 mo
Exagamglogene autotemcel: 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 Exagamglogene autotemcel.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
