pegaspargase (Oncaspar)
pegaspargase is an FDA-licensed reference biologic from Servier Pharmaceuticals LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1994
Reference approved
Reference product
Oncaspar pegaspargase
Servier Pharmaceuticals LLC
- Approved
- Feb 01, 1994
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for pegaspargase, in chronological order.
Reference approval
Approval date of the reference pegaspargase product.
32 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
25 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for pegaspargase (Oncaspar)?
No 351(k) biosimilars or interchangeable biosimilars referencing pegaspargase are listed in the FDA Purple Book yet.
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