small molecule

TRIKAFTA (COPACKAGED)

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

Loss of exclusivityJuly 2038latest FDA-listed patent expiry
CompanyVERTEX PHARMACEUTICALS INC

Drug detail

Brand nameTRIKAFTA (COPACKAGED)
Active ingredientELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Strength100MG,75MG,50MG; 150MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2019
Marketing statusRX

Listed patents

PatentExpiresType
12350262July 2038use U-4475
11453655December 2037substance, product
11179367December 2037product
10793547December 2037substance, product
11517564December 2037product
11426407October 2035substance, product
10758534October 2035substance, product
9012496July 2033use U-3154
RE50453July 2031substance, product
10081621March 2031product
11578062March 2031product
10646481August 2029product
12458635August 2029product
11564916August 2029use U-4491
8415387November 2027use U-4475
8324242August 2027use U-4475
7776905June 2027substance, product
7495103May 2027substance, product
7645789May 2027substance, product
8598181May 2027use U-4475
8623905May 2027substance, product
10022352April 2027product
11639347April 2027substance, product
9974781April 2027product
10239867April 2027substance, product
8410274December 2026product
8754224December 2026substance, product
9931334December 2026product
9670163December 2026product
8354427July 2026use U-3145

Regulatory exclusivity

CodeExpires
ODE-543March 2033
ODE-512December 2031
ODE-357June 2028
ODE-323December 2027
M-313December 2027
ODE-275October 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.

TRIKAFTA (COPACKAGED) patent cliff — loss of exclusivity July 2038 | CliffBio