biologic

Apidra

insulin glulisine

Loss of exclusivityApril 2016projected — 12-year biologic exclusivity estimate
CompanySanofi-Aventis U.S. LLC

Drug detail

Brand nameApidra
Active ingredientinsulin glulisine
Strength1,000UNITS/10ML (100UNITS/ML)
Dosage formInjection
RouteIntravenous, Subcutaneous
ModalityBiologic
FDA approvalApril 2004
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 April 2016 | CliffBio