Purple Book reference family · 351(a) biologic
alefacept (Amevive)
alefacept is an FDA-licensed reference biologic from Astellas Pharma US, Inc..
351(a) biologicBLA 125036 Astellas Pharma US, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2003
Reference product
Originator biologic
351(a)BLA 125036
Amevive alefacept
Astellas Pharma US, 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 alefacept product.
23 yr 10 mo ago
alefacept: 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 alefacept.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

