Brexucabtagene Autoleucel (Tecartus)
Brexucabtagene Autoleucel is an FDA-licensed reference biologic from Kite Pharma, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2020
Reference approved
Reference product
Tecartus Brexucabtagene Autoleucel
Kite Pharma, Inc.
- Approved
- Jul 24, 2020
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Brexucabtagene Autoleucel, in chronological order.
Reference approval
Approval date of the reference Brexucabtagene Autoleucel product.
5 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr 4 mo
Frequently asked questions
Are there biosimilars approved for Brexucabtagene Autoleucel (Tecartus)?
No 351(k) biosimilars or interchangeable biosimilars referencing Brexucabtagene Autoleucel are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.