small molecule

SOTYLIZE

SOTALOL HYDROCHLORIDE

Loss of exclusivityAugust 2035latest FDA-listed patent expiry
CompanyAzurity PharmaceuticalsView the full company profile on CliffBio

Drug detail

Brand nameSOTYLIZE
Active ingredientSOTALOL HYDROCHLORIDE
Strength5MG/ML (5MG/ML)
Dosage formSOLUTION
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2014
Marketing statusRX

Listed patents

PatentExpiresType
9724297August 2035product
11850222November 2034use U-2494
10206895April 2034product
12290495April 2034use U-2494
11013703April 2034product

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.

SOTYLIZE patent cliff — loss of exclusivity August 2035 | CliffBio