remestemcel-L-rknd (ryoncil)
remestemcel-L-rknd is an FDA-licensed reference biologic from Mesoblast, 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
ryoncil remestemcel-L-rknd
Mesoblast, Inc.
- Approved
- Dec 18, 2024
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for remestemcel-L-rknd, in chronological order.
First licensure
Date remestemcel-L-rknd was first licensed by the FDA.
1 yr 6 mo ago
Reference approval
Approval date of the reference remestemcel-L-rknd product.
1 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 8 mo
Frequently asked questions
Are there biosimilars approved for remestemcel-L-rknd (ryoncil)?
No 351(k) biosimilars or interchangeable biosimilars referencing remestemcel-L-rknd are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.