Purple Book reference family · 351(a) biologic
evolocumab (Repatha)
evolocumab is an FDA-licensed reference biologic from Amgen Inc..
351(a) biologicBLA 125522 Amgen Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2016
Reference product
Originator biologic
351(a)BLA 125522
Repatha evolocumab
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 evolocumab product.
10 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 2 yr
evolocumab: 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 evolocumab.
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