Purple Book reference family · 351(a) biologic
insulin degludec and liraglutide (Xultophy 100/3.6)
insulin degludec and liraglutide is an FDA-licensed reference biologic from Novo Nordisk Inc..
351(a) biologicBLA 208583 Novo Nordisk Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2016
Reference product
Originator biologic
351(a)BLA 208583
Xultophy 100/3.6 insulin degludec and liraglutide
Novo Nordisk Inc.
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 degludec and liraglutide product.
9 yr 10 mo ago
insulin degludec and liraglutide: 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 degludec and liraglutide.
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