FDA Purple Book · Reference family
alefacept (Amevive)
alefacept is an FDA-licensed reference biologic from Astellas Pharma US, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2003
Reference approved
Reference product
351(a)BLA 125036
Amevive alefacept
Astellas Pharma US, Inc.
- Approved
- Jan 30, 2003
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for alefacept, in chronological order.
Reference approval
Approval date of the reference alefacept product.
23 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for alefacept (Amevive)?
No 351(k) biosimilars or interchangeable biosimilars referencing alefacept are listed in the FDA Purple Book yet.
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