small molecule

BYSANTI

MILSAPERIDONE

Loss of exclusivityMay 2044latest FDA-listed patent expiry
CompanyVanda PharmaceuticalsSee this company's full patent-cliff portfolio

Drug detail

Brand nameBYSANTI
Active ingredientMILSAPERIDONE
Strength6MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2026
Marketing statusRX

Listed patents

PatentExpiresType
12478619May 2044use U-4434
9074254December 2031use U-4436
9074256February 2031use U-4437
9072742January 2031use U-4437
9074255December 2030use U-4436
8999638October 2030use U-4437
12606869September 2030use U-4507
10563259July 2030use U-4437
9157121April 2030use U-4436
10570453March 2028use U-4436

Regulatory exclusivity

CodeExpires
NCEFebruary 2031

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.

BYSANTI patent cliff — loss of exclusivity May 2044 | CliffBio