biologic

Humulin R U-500

insulin human

Loss of exclusivityDecember 2027projected — 12-year biologic exclusivity estimate
CompanyEli Lilly and Company

Drug detail

Brand nameHumulin R U-500
Active ingredientinsulin human
Strength1,500UNITS/3ML (500UNITS/ML)
Dosage formInjection
RouteSubcutaneous
ModalityBiologic
FDA approvalDecember 2015
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.

Humulin R U-500 patent cliff — loss of exclusivity December 2027 | CliffBio