small molecule

ADDYI

FLIBANSERIN

Loss of exclusivityDecember 2028FDA regulatory exclusivity expiry
CompanySproutSee this company's full patent-cliff portfolio

Drug detail

Brand nameADDYI
Active ingredientFLIBANSERIN
Strength100MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalAugust 2015
Marketing statusRX

Listed patents

PatentExpiresType
7151103May 2028use U-1734

Regulatory exclusivity

CodeExpires
I-983December 2028

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

ADDYI patent cliff — loss of exclusivity December 2028 | CliffBio