tisagenlecleucel (Kymriah)
tisagenlecleucel is an FDA-licensed reference biologic from Novartis Pharmaceuticals Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2017
Reference approved
Reference product
Kymriah tisagenlecleucel
Novartis Pharmaceuticals Corporation
- Approved
- Aug 30, 2017
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for tisagenlecleucel, in chronological order.
Reference approval
Approval date of the reference tisagenlecleucel product.
8 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 7 mo
Frequently asked questions
Are there biosimilars approved for tisagenlecleucel (Kymriah)?
No 351(k) biosimilars or interchangeable biosimilars referencing tisagenlecleucel are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.