Voretigene Neparvovec (Luxturna)
Voretigene Neparvovec is an FDA-licensed reference biologic from Spark Therapeutics, Inc.. 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
Luxturna Voretigene Neparvovec
Spark Therapeutics, Inc.
- Approved
- Dec 19, 2017
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Voretigene Neparvovec, in chronological order.
Reference approval
Approval date of the reference Voretigene Neparvovec product.
8 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for Voretigene Neparvovec (Luxturna)?
No 351(k) biosimilars or interchangeable biosimilars referencing Voretigene Neparvovec are listed in the FDA Purple Book yet.
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