denileukin diftitox (Ontak)
denileukin diftitox is an FDA-licensed reference biologic from Eisai, Incorporated. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1999
Reference approved
Reference product
Ontak denileukin diftitox
Eisai, Incorporated
- Approved
- Feb 05, 1999
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for denileukin diftitox, in chronological order.
Reference approval
Approval date of the reference denileukin diftitox product.
27 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
20 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for denileukin diftitox (Ontak)?
No 351(k) biosimilars or interchangeable biosimilars referencing denileukin diftitox are listed in the FDA Purple Book yet.
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