biologic

Zenpep

pancrelipase

Loss of exclusivityOctober 2035projected — 12-year biologic exclusivity estimate
CompanyAimmune Therapeutics, Inc.

Drug detail

Brand nameZenpep
Active ingredientpancrelipase
Strength60,000USP UNITS; 189,600USP UNITS; 252,600USP UNITS
Dosage formCapsule, Delayed Release
RouteOral
ModalityBiologic
FDA approvalOctober 2023
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.

Zenpep patent cliff — loss of exclusivity October 2035 | CliffBio