dinutuximab (Unituxin)
dinutuximab is an FDA-licensed reference biologic from United Therapeutics Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2015
Reference approved
Reference product
Unituxin dinutuximab
United Therapeutics Corporation
- Approved
- Mar 10, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for dinutuximab, in chronological order.
Reference approval
Approval date of the reference dinutuximab product.
11 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
4 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for dinutuximab (Unituxin)?
No 351(k) biosimilars or interchangeable biosimilars referencing dinutuximab are listed in the FDA Purple Book yet.
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