betibeglogene autotemcel (Zynteglo)
betibeglogene autotemcel is an FDA-licensed reference biologic from Genetix Biotherapeutics Inc.. 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
Zynteglo betibeglogene autotemcel
Genetix Biotherapeutics Inc.
- Approved
- Aug 17, 2022
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for betibeglogene autotemcel, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
93 yr 3 mo ago
First licensure
Date betibeglogene autotemcel was first licensed by the FDA.
4 yr ago
Reference approval
Approval date of the reference betibeglogene autotemcel product.
4 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 2 mo
Frequently asked questions
Are there biosimilars approved for betibeglogene autotemcel (Zynteglo)?
No 351(k) biosimilars or interchangeable biosimilars referencing betibeglogene autotemcel are listed in the FDA Purple Book yet.
When does betibeglogene autotemcel (Zynteglo) lose reference-product exclusivity?
betibeglogene autotemcel's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending August 17, 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.