biologic

Apidra

insulin glulisine

Loss of exclusivityFebruary 2021projected — 12-year biologic exclusivity estimate
CompanySanofi-Aventis U.S. LLC

Drug detail

Brand nameApidra
Active ingredientinsulin glulisine
Strength300UNITS/3ML (100UNITS/ML)
Dosage formInjection
RouteSubcutaneous
ModalityBiologic
FDA approvalFebruary 2009
Marketing statusRx

Source: FDA Purple Book, layered on the CliffBio company graph. Cliff dates are the projected — 12-year biologic exclusivity estimate; estimates are projections, not legal advice.

Apidra patent cliff — loss of exclusivity February 2021 | CliffBio