Purple Book reference family · 351(a) biologic
aldesleukin (Proleukin)
aldesleukin is an FDA-licensed reference biologic from Iovance Biotherapeutics Manufacturing LLC.
351(a) biologicBLA 103293 Iovance Biotherapeutics Manufacturing LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
1992
Reference product
Originator biologic
351(a)BLA 103293
Proleukin aldesleukin
Iovance Biotherapeutics Manufacturing LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference aldesleukin product.
34 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
22 yr ago
aldesleukin: 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 aldesleukin.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
