biologic

Zenpep

pancrelipase

Loss of exclusivityMarch 2026projected — 12-year biologic exclusivity estimate
CompanyAimmune Therapeutics, Inc.

Drug detail

Brand nameZenpep
Active ingredientpancrelipase
Strength40,000USP UNITS; 126,000USP UNITS; 168,000USP UNITS
Dosage formCapsule, Delayed Release
RouteOral
ModalityBiologic
FDA approvalMarch 2014
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 March 2026 | CliffBio