loncastuximab tesirine-lpyl (Zynlonta)
loncastuximab tesirine-lpyl is an FDA-licensed reference biologic from ADC Therapeutics SA. 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
Zynlonta loncastuximab tesirine-lpyl
ADC Therapeutics SA
- Approved
- Apr 23, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for loncastuximab tesirine-lpyl, in chronological order.
Reference approval
Approval date of the reference loncastuximab tesirine-lpyl product.
5 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 11 mo
Frequently asked questions
Are there biosimilars approved for loncastuximab tesirine-lpyl (Zynlonta)?
No 351(k) biosimilars or interchangeable biosimilars referencing loncastuximab tesirine-lpyl 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.