small molecule

AUGTYRO

REPOTRECTINIB

Loss of exclusivityJuly 2036latest FDA-listed patent expiry
CompanyBRISTOL MYERS SQUIBB CO

Drug detail

Brand nameAUGTYRO
Active ingredientREPOTRECTINIB
Strength40MG
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2023
Marketing statusRX

Listed patents

PatentExpiresType
11452725July 2036use U-3755
12310968July 2036use U-3755
10294242July 2036substance
12187739July 2036product
RE50634January 2035substance, product

Regulatory exclusivity

CodeExpires
ODE-483June 2031
ODE-455November 2030
NCENovember 2028

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.

AUGTYRO patent cliff — loss of exclusivity July 2036 | CliffBio