Purple Book reference family · 351(a) biologic
pegloticase (Krystexxa)
pegloticase is an FDA-licensed reference biologic from Horizon Therapeutics Ireland DAC.
351(a) biologicBLA 125293 Horizon Therapeutics Ireland DAC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2010
Reference product
Originator biologic
351(a)BLA 125293
Krystexxa pegloticase
Horizon Therapeutics Ireland DAC
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 pegloticase product.
16 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
9 yr 2 mo ago
pegloticase: 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 pegloticase.
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