Purple Book reference family · 351(a) biologic
remestemcel-L-rknd (ryoncil)
remestemcel-L-rknd is an FDA-licensed reference biologic from Mesoblast, Inc..
351(a) biologicBLA 125706 Mesoblast, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2024
Reference product
Originator biologic
351(a)BLA 125706
ryoncil remestemcel-L-rknd
Mesoblast, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
First licensure
Date remestemcel-L-rknd was first licensed by the FDA.
1 yr 9 mo ago
Reference approval
Approval date of the reference remestemcel-L-rknd product.
1 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr 4 mo
remestemcel-L-rknd: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for remestemcel-L-rknd.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
