insulin aspart (Fiasp)
insulin aspart is an FDA-licensed reference biologic from Novo Nordisk Inc., with 3 approved follow-on biologics.
Reference product
Fiasp insulin aspart
Novo Nordisk Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for insulin aspart from the RCSB Protein Data Bank (PDB 25HF).
Interactive biological assembly from PDB entry 25HF. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.
Exclusivity & patent cliffs
Reference approval
Approval date of the reference insulin aspart product.
3 yr 4 mo ago
Biosimilars & interchangeables for insulin aspart
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Merilog | insulin aspart-szjj | Sanofi-Aventis U.S. LLC | Biosimilar 351(k) | 761325 | |
| Kirsty | insulin aspart-xjhz | Biocon Biologics Inc. | Interchangeable | 761188 | |
| Garzulys | insulin aspart-fsan | Emerge Bioscience Pte. Ltd. | Biosimilar 351(k) | 761497 |
insulin aspart: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for insulin aspart.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
