Products Affected - Description

• • Lantus subcutaneous injection, Sanofi-Aventis, 100 units/mL, 10 mL vial, NDC 00088-2220-33
  • Semglee subcutaneous injection, Biocon, 100 units/mL, 10 mL vial, NDC 83257-0011-11
  • Semglee Pen subcutaneous injection, Biocon, 100 units/mL, 3 mL pen injector, 5 count, NDC 83257-0012-33
  • Insulin glargine-yfgn, recombinant subcutaneous injection, Biocon, 100 units/mL, 10 mL vial, NDC 83257-0014-11
  • Insulin glargine-yfgn, recombinant subcutaneous injection, Biocon, 100 units/mL, 3 mL pen injector, 5 count, NDC 83257-0015-32

Reason for the Shortage

• • Biocon states the reason for the shortage is increased demand due to competitors exiting the market. Biocon is expanding capacity at their insulin production facility. The company anticipates supply interruption through the remainder of 2025.
  • Lilly has Basaglar and Rezvoglar available.
  • Sanofi did not provide a reason for the shortage.
  • Winthrop has insulin glargine injection available.

Available Products

• • Basaglar Kwikpen subcutaneous injection, Lilly USA, LLC, 100 units/mL, 3 mL pen injector, 5 count, NDC 00002-7715-59
  • Basaglar Tempo Pen subcutaneous injection, Lilly USA, LLC, 100 units/mL, 3 mL pen injector, 5 count, NDC 00002-8214-05
  • Insulin Glargine U-300 Max Solostar subcutaneous injection, Winthrop, 300 units/mL, 3 mL pen injector, 2 count, NDC 00955-2900-02
  • Insulin Glargine U-300 Solostar subcutaneous injection, Winthrop, 300 units/mL, 1.5 mL pen injector, 3 count, NDC 00955-3900-03
  • Lantus Solostar Pen subcutaneous injection, Sanofi-Aventis, 100 units/mL, 3 mL pen injector, 5 count, NDC 00088-2219-05
  • Rezvoglar Kwikpen subcutaneous injection, Lilly USA, LLC, 100 units/mL, 3 mL pen injector, 5 count, NDC 00002-8980-05
  • Toujeo 1.5 mL Prefilled Pen subcutaneous injection, Sanofi-Aventis, 300 units/mL, 1.5 mL pen injector, 3 count, NDC 00024-5869-03
  • Toujeo Max 3 mL Prefilled Pen subcutaneous injection, Sanofi-Aventis, 300 units/mL, 3 mL pen injector, 2 count, NDC 00024-5871-02

• • Biocon anticipates insulin glargine-yfgn pens will be out of stock from early-August 2025 to mid-September 2025. Insulin Glargine-yfgn vials are expected to be out of stock from early-August 2025 to mid-October 2025. Semglee pens and vials will continue to have intermittent supply until the end of December 2025. In January 2025, the company will phase out Semglee pens and vials.
  • Sanofi Aventis has Lantus 10 mL vials on back order and the company estimates a release date in late-July 2025.