ciltacabtagene autoleucel (Carvykti)
ciltacabtagene autoleucel is an FDA-licensed reference biologic from Janssen Biotech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2022
Reference approved
Reference product
Carvykti ciltacabtagene autoleucel
Janssen Biotech, Inc.
- Approved
- Feb 28, 2022
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for ciltacabtagene autoleucel, in chronological order.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
96 yr 8 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
93 yr 9 mo ago
First licensure
Date ciltacabtagene autoleucel was first licensed by the FDA.
4 yr 5 mo ago
Reference approval
Approval date of the reference ciltacabtagene autoleucel product.
4 yr 5 mo ago
Frequently asked questions
Are there biosimilars approved for ciltacabtagene autoleucel (Carvykti)?
No 351(k) biosimilars or interchangeable biosimilars referencing ciltacabtagene autoleucel are listed in the FDA Purple Book yet.
When does ciltacabtagene autoleucel (Carvykti) lose reference-product exclusivity?
ciltacabtagene autoleucel's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending February 28, 1934.
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.