insulin glulisine (Apidra)
insulin glulisine is an FDA-licensed reference biologic from Sanofi-Aventis U.S. LLC. 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
Apidra insulin glulisine
Sanofi-Aventis U.S. LLC
- Approved
- Dec 20, 2005
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for insulin glulisine from the RCSB Protein Data Bank (PDB 6GV0).
Interactive biological assembly from PDB entry 6GV0. 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 glulisine, in chronological order.
Reference approval
Approval date of the reference insulin glulisine product.
20 yr 10 mo ago
Frequently asked questions
Are there biosimilars approved for insulin glulisine (Apidra)?
No 351(k) biosimilars or interchangeable biosimilars referencing insulin glulisine 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.