small molecule

PREVYMIS

LETERMOVIR

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

Drug detail

Brand namePREVYMIS
Active ingredientLETERMOVIR
Strength480MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2017
Marketing statusRX

Listed patents

PatentExpiresType
RE46791January 2029substance, product

Regulatory exclusivity

CodeExpires
ODE-495August 2031
ODE-497August 2031
ODE-423June 2030
NPPAugust 2027
D-189August 2026
I-916June 2026

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