FDA Purple Book · Reference family
lixisenatide (Adlyxin)
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
351(a)BLA 208471
Adlyxin lixisenatide
Sanofi-Aventis U.S. LLC
- Approved
- Jul 27, 2016
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for lixisenatide, in chronological order.
Reference approval
Approval date of the reference lixisenatide product.
10 yr ago
Frequently asked questions
Are there biosimilars approved for lixisenatide (Adlyxin)?
No 351(k) biosimilars or interchangeable biosimilars referencing lixisenatide are listed in the FDA Purple Book yet.
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