small molecule

ROZLYTREK

ENTRECTINIB

Loss of exclusivityOctober 2030FDA regulatory exclusivity expiry
CompanyGenentechSee this company's full patent-cliff portfolio

Drug detail

Brand nameROZLYTREK
Active ingredientENTRECTINIB
Strength50MG/PACKET
Dosage formPELLETS
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2023
Marketing statusRX

Regulatory exclusivity

CodeExpires
ODE-448October 2030
NPOctober 2026
ODE*August 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.

ROZLYTREK patent cliff — loss of exclusivity October 2030 | CliffBio