Obecabtagene autoleucel (Aucatzyl)
Obecabtagene autoleucel is an FDA-licensed reference biologic from Autolus, 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
Aucatzyl Obecabtagene autoleucel
Autolus, Inc.
- Approved
- Nov 08, 2024
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Obecabtagene autoleucel, in chronological order.
First licensure
Date Obecabtagene autoleucel was first licensed by the FDA.
1 yr 7 mo ago
Reference approval
Approval date of the reference Obecabtagene autoleucel product.
1 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 6 mo
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 10 yr 7 mo
Frequently asked questions
Are there biosimilars approved for Obecabtagene autoleucel (Aucatzyl)?
No 351(k) biosimilars or interchangeable biosimilars referencing Obecabtagene autoleucel are listed in the FDA Purple Book yet.
When does Obecabtagene autoleucel (Aucatzyl) lose reference-product exclusivity?
Obecabtagene autoleucel's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending November 8, 2036.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.