Purple Book reference family · 351(a) biologic
calaspargase pegol-mknl (Asparlas)
calaspargase pegol-mknl is an FDA-licensed reference biologic from Servier Pharmaceuticals LLC.
351(a) biologicBLA 761102 Servier Pharmaceuticals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2018
Reference product
Originator biologic
351(a)BLA 761102
Asparlas calaspargase pegol-mknl
Servier Pharmaceuticals LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
26 yr ago
Reference approval
Approval date of the reference calaspargase pegol-mknl product.
7 yr 10 mo ago
calaspargase pegol-mknl: 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 calaspargase pegol-mknl.
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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.
