Purple Book reference family · 351(a) biologic
mirvetuximab soravtansine-gynx (Elahere)
mirvetuximab soravtansine-gynx is an FDA-licensed reference biologic from ImmunoGen, Inc..
351(a) biologicBLA 761310 ImmunoGen, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2022
Reference product
Originator biologic
351(a)BLA 761310
Elahere mirvetuximab soravtansine-gynx
ImmunoGen, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference mirvetuximab soravtansine-gynx product.
3 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 2 mo
mirvetuximab soravtansine-gynx: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for mirvetuximab soravtansine-gynx.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
