Purple Book reference family · 351(a) biologic
lixisenatide (Adlyxin)
lixisenatide is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC.
351(a) biologicBLA 208471 Sanofi-Aventis U.S. LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2016
Reference product
Originator biologic
351(a)BLA 208471
Adlyxin lixisenatide
Sanofi-Aventis U.S. LLC
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 lixisenatide product.
10 yr 2 mo ago
lixisenatide: 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 lixisenatide.
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