insulin glargine (Basaglar)
insulin glargine is an FDA-licensed reference biologic from Eli Lilly and Company, with 3 approved follow-on biologics.
Reference product
Basaglar insulin glargine
Eli Lilly and Company
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for insulin glargine from the RCSB Protein Data Bank (PDB 6K59).
Interactive biological assembly from PDB entry 6K59. 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 glargine product.
6 yr 11 mo ago
Biosimilars & interchangeables for insulin glargine
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Semglee | insulin glargine-yfgn | Biocon Biologics Inc. | Interchangeable | 761201 | |
| Rezvoglar | insulin glargine-aglr | Eli Lilly and Company | Interchangeable | 761215 | |
| Langlara | insulin glargine-aldy | Sunshine Lake Pharma Co., Ltd. | Interchangeable | 761412 |
insulin glargine: 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 glargine.
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.
