Purple Book reference family · 351(a) biologic
pariglasgene brecaparvovec-opnr (GENGLYCOS)
pariglasgene brecaparvovec-opnr is an FDA-licensed reference biologic from Ultragenyx Pharmaceutical, Inc..
351(a) biologicBLA 125858 Ultragenyx Pharmaceutical, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 125858
GENGLYCOS pariglasgene brecaparvovec-opnr
Ultragenyx Pharmaceutical, 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 pariglasgene brecaparvovec-opnr product.
2 mo ago
pariglasgene brecaparvovec-opnr: 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 pariglasgene brecaparvovec-opnr.
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