mirvetuximab soravtansine-gynx (Elahere)
mirvetuximab soravtansine-gynx is an FDA-licensed reference biologic from ImmunoGen, 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
Elahere mirvetuximab soravtansine-gynx
ImmunoGen, Inc.
- Approved
- Nov 14, 2022
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for mirvetuximab soravtansine-gynx, in chronological order.
Reference approval
Approval date of the reference mirvetuximab soravtansine-gynx product.
3 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 6 mo
Frequently asked questions
Are there biosimilars approved for mirvetuximab soravtansine-gynx (Elahere)?
No 351(k) biosimilars or interchangeable biosimilars referencing mirvetuximab soravtansine-gynx 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.