lisocabtagene maraleucel (Breyanzi)
lisocabtagene maraleucel is an FDA-licensed reference biologic from Juno Therapeutics, Inc. a Bristol Myer-Squibb Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2021
Reference approved
Reference product
Breyanzi lisocabtagene maraleucel
Juno Therapeutics, Inc. a Bristol Myer-Squibb Company
- Approved
- Feb 05, 2021
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for lisocabtagene maraleucel, in chronological order.
Reference approval
Approval date of the reference lisocabtagene maraleucel product.
5 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 1 mo
Frequently asked questions
Are there biosimilars approved for lisocabtagene maraleucel (Breyanzi)?
No 351(k) biosimilars or interchangeable biosimilars referencing lisocabtagene maraleucel are listed in the FDA Purple Book yet.
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