Purple Book reference family · 351(a) biologic
insulin degludec (Tresiba)
insulin degludec is an FDA-licensed reference biologic from Novo Nordisk Inc..
351(a) biologicBLA 203314 Novo Nordisk Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2015
Reference product
Originator biologic
351(a)BLA 203314
Tresiba insulin degludec
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 product.
11 yr ago
insulin degludec: 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.
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