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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
  1. 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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Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.