biologic

Keytruda Qlex

pembrolizumab and berahyaluronidase alfa-pmph

Loss of exclusivitySeptember 2037projected — 12-year biologic exclusivity estimate
CompanyMerck Sharp & Dohme LLC

Drug detail

Brand nameKeytruda Qlex
Active ingredientpembrolizumab and berahyaluronidase alfa-pmph
Strength790MG/4.8ML; 9,600UNITS/4.8ML (165MG/2,000UNITS/ML)
Dosage formInjection
RouteSubcutaneous
ModalityBiologic
FDA approvalSeptember 2025
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.

Keytruda Qlex patent cliff — loss of exclusivity September 2037 | CliffBio