small molecule

PENNSAID

DICLOFENAC SODIUM

Loss of exclusivityAugust 2030latest FDA-listed patent expiry
CompanyHORIZON THERAPEUTICS IRELAND DAC

Drug detail

Brand namePENNSAID
Active ingredientDICLOFENAC SODIUM
Strength2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage formSOLUTION
RouteTOPICAL
ModalitySmall molecule
FDA approvalJanuary 2014
Marketing statusDISCN

Listed patents

PatentExpiresType
8546450August 2030use U-1436
8618164July 2029use U-1477
9370501July 2029use U-1614
9375412July 2029use U-1614
8741956July 2029use U-1435
8217078July 2029use U-1477
9415029July 2029use U-1614
8252838April 2028product
9339551October 2027use U-1488
9066913October 2027product
9168305October 2027use U-1488
9220784October 2027use U-1488
9132110October 2027use U-1488
9339552October 2027product
9539335October 2027use U-1614
8563613October 2027product
8871809October 2027use U-1614
9101591October 2027product
9168304October 2027product

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.

PENNSAID patent cliff — loss of exclusivity August 2030 | CliffBio