Purple Book reference family · 351(a) biologic
insulin glargine and lixisenatide (Soliqua 100/33)
insulin glargine and lixisenatide is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC.
351(a) biologicBLA 208673 Sanofi-Aventis U.S. LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2016
Reference product
Originator biologic
351(a)BLA 208673
Soliqua 100/33 insulin glargine and lixisenatide
Sanofi-Aventis U.S. LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference insulin glargine and lixisenatide product.
9 yr 10 mo ago
insulin glargine and 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 insulin glargine and lixisenatide.
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