small molecule

ROZLYTREK

ENTRECTINIB

Loss of exclusivityJuly 2038latest FDA-listed patent expiry
CompanyGenentechSee this company's full patent-cliff portfolio

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