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.
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
96 yr ago
First licensure
Date remestemcel-L-rknd was first licensed by the FDA.
1 yr 7 mo ago
Reference approval
Approval date of the reference remestemcel-L-rknd product.
1 yr 7 mo ago
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.
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.