fidanacogene elaparvovec-dzkt (BEQVEZ)
fidanacogene elaparvovec-dzkt is an FDA-licensed reference biologic from Pfizer Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
BEQVEZ fidanacogene elaparvovec-dzkt
Pfizer Inc.
- Approved
- Apr 25, 2024
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for fidanacogene elaparvovec-dzkt, in chronological order.
First licensure
Date fidanacogene elaparvovec-dzkt was first licensed by the FDA.
2 yr 2 mo ago
Reference approval
Approval date of the reference fidanacogene elaparvovec-dzkt product.
2 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 10 yr 1 mo
Frequently asked questions
Are there biosimilars approved for fidanacogene elaparvovec-dzkt (BEQVEZ)?
No 351(k) biosimilars or interchangeable biosimilars referencing fidanacogene elaparvovec-dzkt are listed in the FDA Purple Book yet.
When does fidanacogene elaparvovec-dzkt (BEQVEZ) lose reference-product exclusivity?
fidanacogene elaparvovec-dzkt's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending April 25, 2036.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.