fecal microbiota, live-jslm (Rebyota)
fecal microbiota, live-jslm is an FDA-licensed reference biologic from Ferring Pharmaceuticals 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
Rebyota fecal microbiota, live-jslm
Ferring Pharmaceuticals Inc.
- Approved
- Nov 30, 2022
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for fecal microbiota, live-jslm, in chronological order.
First licensure
Date fecal microbiota, live-jslm was first licensed by the FDA.
3 yr 7 mo ago
Reference approval
Approval date of the reference fecal microbiota, live-jslm product.
3 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 7 mo
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 8 yr 7 mo
Frequently asked questions
Are there biosimilars approved for fecal microbiota, live-jslm (Rebyota)?
No 351(k) biosimilars or interchangeable biosimilars referencing fecal microbiota, live-jslm are listed in the FDA Purple Book yet.
When does fecal microbiota, live-jslm (Rebyota) lose reference-product exclusivity?
fecal microbiota, live-jslm's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending November 30, 2034.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.