Purple Book reference family · 351(a) biologic
denileukin diftitox (Ontak)
denileukin diftitox is an FDA-licensed reference biologic from Eisai, Incorporated.
351(a) biologicBLA 103767 Eisai, Incorporated
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1999
Reference product
Originator biologic
351(a)BLA 103767
Ontak denileukin diftitox
Eisai, Incorporated
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference denileukin diftitox product.
28 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
20 yr 11 mo ago
denileukin diftitox: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for denileukin diftitox.
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