Purple Book reference family · 351(a) biologic
Voretigene Neparvovec (Luxturna)
Voretigene Neparvovec is an FDA-licensed reference biologic from Spark Therapeutics, Inc..
351(a) biologicBLA 125610 Spark Therapeutics, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017
Reference product
Originator biologic
351(a)BLA 125610
Luxturna Voretigene Neparvovec
Spark Therapeutics, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Voretigene Neparvovec product.
8 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 9 mo ago
Voretigene Neparvovec: 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 Voretigene Neparvovec.
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