Purple Book reference family · 351(a) biologic
pegvaliase-pqpz (Palynziq)
pegvaliase-pqpz is an FDA-licensed reference biologic from BioMarin Pharmaceutical Inc..
351(a) biologicBLA 761079 BioMarin Pharmaceutical Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2018
Reference product
Originator biologic
351(a)BLA 761079
Palynziq pegvaliase-pqpz
BioMarin Pharmaceutical Inc.
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 pegvaliase-pqpz product.
8 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 4 mo ago
pegvaliase-pqpz: 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 pegvaliase-pqpz.
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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.
