FDA Purple Book · Reference family
insulin degludec (Tresiba)
insulin degludec 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
2015
Reference approved
Reference product
351(a)BLA 203314
Tresiba insulin degludec
Novo Nordisk Inc.
- Approved
- Sep 25, 2015
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin degludec, in chronological order.
Reference approval
Approval date of the reference insulin degludec product.
10 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for insulin degludec (Tresiba)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin degludec are listed in the FDA Purple Book yet.
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