Purple Book reference family · 351(a) biologic
marnetegragene autotemcel (kresladi)
marnetegragene autotemcel is an FDA-licensed reference biologic from Rocket Pharmaceuticals Inc.
351(a) biologicBLA 125806 Rocket Pharmaceuticals Inc
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 125806
kresladi marnetegragene autotemcel
Rocket Pharmaceuticals Inc
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference marnetegragene autotemcel product.
4 mo ago
marnetegragene autotemcel: 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 marnetegragene autotemcel.
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- 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.

