Purple Book reference family · 351(a) biologic
pegzilarginase-nbln (Loargys)
pegzilarginase-nbln is an FDA-licensed reference biologic from Immedica Pharma AB.
351(a) biologicBLA 761211 Immedica Pharma AB
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 761211
Loargys pegzilarginase-nbln
Immedica Pharma AB
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference pegzilarginase-nbln product.
5 mo ago
pegzilarginase-nbln: 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 pegzilarginase-nbln.
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.
