small molecule

SYMDEKO (COPACKAGED)

IVACAFTOR; IVACAFTOR, TEZACAFTOR

Loss of exclusivityApril 2035latest FDA-listed patent expiry
CompanyVERTEX PHARMACEUTICALS INC

Drug detail

Brand nameSYMDEKO (COPACKAGED)
Active ingredientIVACAFTOR; IVACAFTOR, TEZACAFTOR
Strength75MG;75MG, 50MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalJune 2019
Marketing statusRX

Listed patents

PatentExpiresType
10206877April 2035product
9012496July 2033use U-2248
10058546July 2033use U-3023
RE50453July 2031substance, product
10081621March 2031product
11578062March 2031product
12458635August 2029product
10646481August 2029product
11564916August 2029use U-3527
8415387November 2027use U-2246
8324242August 2027use U-2246
7776905June 2027substance, product
7495103May 2027substance, product
7645789May 2027substance, product
8598181May 2027use U-2246
8623905May 2027substance, product
10022352April 2027product
10239867April 2027substance, product
11639347April 2027substance, product
9974781April 2027product
9931334December 2026product
9670163December 2026product
8754224December 2026substance, product
8410274December 2026product
8354427July 2026use U-3021

Regulatory exclusivity

CodeExpires
ODE-335December 2027
ODE-247June 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.