small molecule

HYSINGLA ER

HYDROCODONE BITARTRATE

Loss of exclusivityDecember 2031latest FDA-listed patent expiry
CompanyKNOAView the full company profile on CliffBio

Drug detail

Brand nameHYSINGLA ER
Active ingredientHYDROCODONE BITARTRATE
Strength20MG
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2014
Marketing statusRX

Listed patents

PatentExpiresType
9572779December 2031product
9872837December 2031product
9861584December 2031product
9750703December 2031product
8808740December 2031product
9084816August 2027product
9763933August 2027product
9486413August 2027product
9492389August 2027product
9775809August 2027product
11304908August 2027product
9486412August 2027product
9770416August 2027product
9545380August 2027use U-1556
9095615August 2027product
9095614August 2027use U-1556
9492391August 2027use U-1556
9492390August 2027use U-1556
11304909August 2027use U-1556

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.

HYSINGLA ER patent cliff — loss of exclusivity December 2031 | CliffBio