pegloticase (Krystexxa)
pegloticase is an FDA-licensed reference biologic from Horizon Therapeutics Ireland DAC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2010
Reference approved
Reference product
Krystexxa pegloticase
Horizon Therapeutics Ireland DAC
- Approved
- Sep 14, 2010
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pegloticase, in chronological order.
Reference approval
Approval date of the reference pegloticase product.
15 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
8 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for pegloticase (Krystexxa)?
No 351(k) biosimilars or interchangeable biosimilars referencing pegloticase are listed in the FDA Purple Book yet.
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