small molecule

OMONTYS

PEGINESATIDE ACETATE

Loss of exclusivityJune 2026latest FDA-listed patent expiry
CompanyTAKEDA PHARMACEUTICALS USA INC

Drug detail

Brand nameOMONTYS
Active ingredientPEGINESATIDE ACETATE
StrengthEQ 10MG BASE/ML (EQ 10MG BASE/ML)
Dosage formSOLUTION
RouteINTRAVENOUS, SUBCUTANEOUS
ModalitySmall molecule
FDA approvalMarch 2012
Marketing statusDISCN

Listed patents

PatentExpiresType
7550433June 2026use U-1238
7919461June 2026use U-1238

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.

OMONTYS patent cliff — loss of exclusivity June 2026 | CliffBio