FDA Purple Book · Reference family
insulin detemir (Levemir)
insulin detemir 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
2005
Reference approved
Reference product
351(a)BLA 021536
Levemir insulin detemir
Novo Nordisk Inc.
- Approved
- Jun 16, 2005
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for insulin detemir, in chronological order.
Reference approval
Approval date of the reference insulin detemir product.
21 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for insulin detemir (Levemir)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin detemir are listed in the FDA Purple Book yet.
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