small molecule

ROZLYTREK

ENTRECTINIB

Loss of exclusivityJuly 2038latest FDA-listed patent expiry
CompanyGenentechView the full company profile on CliffBio

Drug detail

Brand nameROZLYTREK
Active ingredientENTRECTINIB
Strength100MG
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalAugust 2019
Marketing statusRX

Listed patents

PatentExpiresType
10398693July 2038product
11253515July 2038product
11091469May 2037use U-2618
10738037May 2037substance, product
10561651February 2035use U-2745
10231965February 2035use U-2617
9085565May 2033substance, product
9649306May 2033use U-2617
8299057March 2032substance, product
9085558July 2028product
9029356July 2028substance, product
9255087July 2028use U-2617
8673893July 2028use U-2617
9616059July 2028use U-2618

Regulatory exclusivity

CodeExpires
ODE-448October 2030
NPPOctober 2026
ODE-265August 2026
ODE-313August 2026

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.

ROZLYTREK patent cliff — loss of exclusivity July 2038 | CliffBio