FDA Purple Book · Reference family
darbepoetin alpha (Aranesp)
darbepoetin alpha is an FDA-licensed reference biologic from Amgen Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2006
Reference approved
Reference product
351(a)BLA 103951
Aranesp darbepoetin alpha
Amgen Inc.
- Approved
- Jun 29, 2006
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for darbepoetin alpha, in chronological order.
Reference approval
Approval date of the reference darbepoetin alpha product.
20 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for darbepoetin alpha (Aranesp)?
No 351(k) biosimilars or interchangeable biosimilars referencing darbepoetin alpha are listed in the FDA Purple Book yet.
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