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
Levemir insulin detemir
Novo Nordisk Inc.
- Approved
- Jun 16, 2005
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for insulin detemir from the RCSB Protein Data Bank (PDB 8IPZ).
Interactive biological assembly from PDB entry 8IPZ. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
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 5 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.