small molecule

POMALYST

POMALIDOMIDE

Loss of exclusivityDecember 2031latest FDA-listed patent expiry
CompanyBRISTOL MYERS SQUIBB CO

Drug detail

Brand namePOMALYST
Active ingredientPOMALIDOMIDE
Strength2MG
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2013
Marketing statusRX

Listed patents

PatentExpiresType
8828427*PEDDecember 2031
8828427June 2031substance, product
9993467*PEDNovember 2030
10555939*PEDNovember 2030
10555939May 2030product
9993467May 2030product

Regulatory exclusivity

CodeExpires
PEDNovember 2027
ODE-296May 2027
ODE-297May 2027

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.

POMALYST patent cliff — loss of exclusivity December 2031 | CliffBio