small molecule

PRETOMANID

PRETOMANID

Loss of exclusivityAugust 2029FDA regulatory exclusivity expiry
CompanyMYLAN IRELAND LTD

Drug detail

Brand namePRETOMANID
Active ingredientPRETOMANID
Strength200MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalAugust 2019
Marketing statusRX

Regulatory exclusivity

CodeExpires
GAINAugust 2029
ODE-253August 2026
NCEAugust 2024

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

PRETOMANID patent cliff — loss of exclusivity August 2029 | CliffBio