insulin glargine and lixisenatide (Soliqua 100/33)
insulin glargine and lixisenatide is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2016
Reference approved
Reference product
Soliqua 100/33 insulin glargine and lixisenatide
Sanofi-Aventis U.S. LLC
- Approved
- Nov 21, 2016
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin glargine and lixisenatide, in chronological order.
Reference approval
Approval date of the reference insulin glargine and lixisenatide product.
9 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for insulin glargine and lixisenatide (Soliqua 100/33)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin glargine and lixisenatide are listed in the FDA Purple Book yet.
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