small molecule

PREVYMIS

LETERMOVIR

Loss of exclusivityAugust 2031FDA regulatory exclusivity expiry
CompanyMERCK SHARP AND DOHME LLC

Drug detail

Brand namePREVYMIS
Active ingredientLETERMOVIR
Strength20MG/PACKET
Dosage formPELLETS
RouteORAL
ModalitySmall molecule
FDA approvalAugust 2024
Marketing statusRX

Listed patents

PatentExpiresType
RE46791January 2029substance, product

Regulatory exclusivity

CodeExpires
ODE-495August 2031
ODE-497August 2031
ODE*June 2030
NPAugust 2027

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

PREVYMIS patent cliff — loss of exclusivity August 2031 | CliffBio