Purple Book reference family · 351(a) biologic
darbepoetin alpha (Aranesp)
darbepoetin alpha is an FDA-licensed reference biologic from Amgen Inc..
351(a) biologicBLA 103951 Amgen Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2006
Reference product
Originator biologic
351(a)BLA 103951
Aranesp darbepoetin alpha
Amgen Inc.
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 darbepoetin alpha product.
20 yr 4 mo ago
darbepoetin alpha: 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 darbepoetin alpha.
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