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.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
96 yr 11 mo ago
Reference approval
Approval date of the reference Exagamglogene autotemcel product.
2 yr 8 mo ago
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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.