nadofaragene firadenovec-vncg (Adstiladrin)
nadofaragene firadenovec-vncg is an FDA-licensed reference biologic from Ferring Pharmaceuticals A/S. 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
Adstiladrin nadofaragene firadenovec-vncg
Ferring Pharmaceuticals A/S
- Approved
- Dec 16, 2022
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for nadofaragene firadenovec-vncg, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
92 yr 11 mo ago
First licensure
Date nadofaragene firadenovec-vncg was first licensed by the FDA.
3 yr 8 mo ago
Reference approval
Approval date of the reference nadofaragene firadenovec-vncg product.
3 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for nadofaragene firadenovec-vncg (Adstiladrin)?
No 351(k) biosimilars or interchangeable biosimilars referencing nadofaragene firadenovec-vncg are listed in the FDA Purple Book yet.
When does nadofaragene firadenovec-vncg (Adstiladrin) lose reference-product exclusivity?
nadofaragene firadenovec-vncg's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending December 16, 1934.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.