small molecule

NICORETTE

NICOTINE POLACRILEX

Loss of exclusivityApril 2028latest FDA-listed patent expiry
CompanyHaleonView the full company profile on CliffBio

Drug detail

Brand nameNICORETTE
Active ingredientNICOTINE POLACRILEX
StrengthEQ 4MG BASE
Dosage formGUM, CHEWING
RouteBUCCAL
ModalitySmall molecule
FDA approvalFebruary 1996
Marketing statusOTC

Listed patents

PatentExpiresType
8323683April 2028product

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

NICORETTE patent cliff — loss of exclusivity April 2028 | CliffBio