FDA Purple Book · Reference family
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
2009
Reference approved
Reference product
351(a)BLA 021629
Apidra insulin glulisine
Sanofi-Aventis U.S. LLC
- Approved
- Feb 24, 2009
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
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.
17 yr 6 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.
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