small molecule

TRIKAFTA (COPACKAGED)

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

Loss of exclusivityDecember 2037latest FDA-listed patent expiry
CompanyVERTEX PHARMACEUTICALS INC

Drug detail

Brand nameTRIKAFTA (COPACKAGED)
Active ingredientELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR
Strength80MG, 60MG, 40MG;59.5MG
Dosage formGRANULE
RouteORAL
ModalitySmall molecule
FDA approvalApril 2023
Marketing statusRX

Listed patents

PatentExpiresType
11179367December 2037product
11453655December 2037substance, product
11517564December 2037product
10793547December 2037substance, product
10758534October 2035substance, product
11426407October 2035substance, product
8883206February 2033product
11752106February 2033product
12214083February 2033product
10272046February 2033product
11147770February 2033product
RE50453July 2031substance, product
10081621March 2031product
11578062March 2031product
12458635August 2029product
11564916August 2029use U-4485
10646481August 2029product
8415387November 2027use U-4476
8324242August 2027use U-4476
7776905June 2027substance, product
7495103May 2027substance, product
7645789May 2027substance, product
8623905May 2027substance, product
8598181May 2027use U-4476
9974781April 2027product
10239867April 2027substance, product
11639347April 2027substance, product
10022352April 2027product
8754224December 2026substance, product
9670163December 2026product
9931334December 2026product
8410274December 2026product
8354427July 2026use U-3593

Regulatory exclusivity

CodeExpires
ODE-543March 2033
ODE-512December 2031
ODE-433April 2030
M-313December 2027
NPApril 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 December 2037 | CliffBio