insulin degludec and liraglutide (Xultophy 100/3.6)
insulin degludec and liraglutide is an FDA-licensed reference biologic from Novo Nordisk Inc.. 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
Xultophy 100/3.6 insulin degludec and liraglutide
Novo Nordisk Inc.
- Approved
- Nov 21, 2016
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin degludec and liraglutide, in chronological order.
Reference approval
Approval date of the reference insulin degludec and liraglutide product.
9 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for insulin degludec and liraglutide (Xultophy 100/3.6)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin degludec and liraglutide are listed in the FDA Purple Book yet.
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Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.