glucarpidase (Voraxaze)
glucarpidase is an FDA-licensed reference biologic from BTG International Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2012
Reference approved
Reference product
Voraxaze glucarpidase
BTG International Inc.
- Approved
- Jan 17, 2012
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for glucarpidase, in chronological order.
Reference approval
Approval date of the reference glucarpidase product.
14 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
7 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for glucarpidase (Voraxaze)?
No 351(k) biosimilars or interchangeable biosimilars referencing glucarpidase 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.