pegvaliase-pqpz (Palynziq)
pegvaliase-pqpz is an FDA-licensed reference biologic from BioMarin Pharmaceutical Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2018
Reference approved
Reference product
Palynziq pegvaliase-pqpz
BioMarin Pharmaceutical Inc.
- Approved
- May 24, 2018
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pegvaliase-pqpz, in chronological order.
Reference approval
Approval date of the reference pegvaliase-pqpz product.
8 yr 2 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr ago
Frequently asked questions
Are there biosimilars approved for pegvaliase-pqpz (Palynziq)?
No 351(k) biosimilars or interchangeable biosimilars referencing pegvaliase-pqpz are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.