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Last Updated: April 22, 2024

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TRIKAFTA (COPACKAGED) Drug Patent Profile


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Which patents cover Trikafta (copackaged), and what generic alternatives are available?

Trikafta (copackaged) is a drug marketed by Vertex Pharms Inc and is included in two NDAs. There are thirty-two patents protecting this drug.

This drug has four hundred and ninety-four patent family members in forty-four countries.

The generic ingredient in TRIKAFTA (COPACKAGED) is elexacaftor, ivacaftor, tezacaftor; ivacaftor. One supplier is listed for this compound. Additional details are available on the elexacaftor, ivacaftor, tezacaftor; ivacaftor profile page.

DrugPatentWatch® Generic Entry Outlook for Trikafta (copackaged)

Trikafta (copackaged) was eligible for patent challenges on October 21, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 8, 2037. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for TRIKAFTA (COPACKAGED)
Drug patent expirations by year for TRIKAFTA (COPACKAGED)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRIKAFTA (COPACKAGED)
Generic Entry Dates for TRIKAFTA (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, TABLET;ORAL
Generic Entry Dates for TRIKAFTA (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULES;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for TRIKAFTA (COPACKAGED)

TRIKAFTA (COPACKAGED) is protected by seventy-seven US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRIKAFTA (COPACKAGED) is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TRIKAFTA (COPACKAGED)

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621

Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621

Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA

Pharmaceutical composition and administrations thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Pharmaceutical composition and administrations thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of cystic fibrosis transmembrane conductance regulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of cystic fibrosis transmembrane conductance regulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of cystic fibrosis transmembrane conductance regulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of cystic fibrosis transmembrane conductance regulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Pharmaceutical composition and administrations thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Pharmaceutical compositions for treating cystic fibrosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Pharmaceutical compositions for treating cystic fibrosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO AT LEAST ONE OF CLAIMS 1-9 OF US11179367

Modulators of cystic fibrosis transmembrane conductance regulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of cystic fibrosis transmembrane conductance regulator
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOUND OF CLAIM 1 OR COMPOSITION OF CLAIM 29 OF US11426407


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of treatment for cystic fibrosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Methods of treatment for cystic fibrosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING DAILY ELX (200 MG OR 100 MG); TEZ; AND IVA


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A MUTATION THAT IS RESPONSIVE BASED ON IN VITRO DATA BY ADMINISTERING THE COMPOSITION RECITED IN US 11564916 CLAIM 1


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA BY ADMINISTERING ELEXACAFTOR, IVACAFTOR, AND A SOLID DISPERSION OF TEZACAFTOR AND A POLYMER


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE IN THE CFTR GENE AT LEAST ONE F508DEL MUTATION OR A RESPONSIVE MUTATION BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Indole derivatives as CFTR modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE ONE F508DEL MUTATION AND ONE R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition and administrations thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide and administration thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR

Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide and administration thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

FDA Regulatory Exclusivity protecting TRIKAFTA (COPACKAGED)

TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
Exclusivity Expiration: ⤷  Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 6 THROUGH 11 YEARS OLD WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
Exclusivity Expiration: ⤷  Try a Trial

INDICATED FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-002 Jun 8, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor GRANULES;ORAL 217660-002 Apr 26, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor GRANULES;ORAL 217660-001 Apr 26, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for TRIKAFTA (COPACKAGED)

When does loss-of-exclusivity occur for TRIKAFTA (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 0346
Estimated Expiration: ⤷  Try a Trial

Patent: 4581
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 17371200
Estimated Expiration: ⤷  Try a Trial

Patent: 19215231
Estimated Expiration: ⤷  Try a Trial

Patent: 21211993
Estimated Expiration: ⤷  Try a Trial

Patent: 23203944
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2019011626
Estimated Expiration: ⤷  Try a Trial

Patent: 2020014487
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 46086
Estimated Expiration: ⤷  Try a Trial

Patent: 88272
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 19001553
Estimated Expiration: ⤷  Try a Trial

China

Patent: 0267948
Estimated Expiration: ⤷  Try a Trial

Patent: 1818918
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 19007129
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0201946
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 23736
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 51622
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 19048759
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9280
Estimated Expiration: ⤷  Try a Trial

Patent: 1991403
Estimated Expiration: ⤷  Try a Trial

Patent: 2192783
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 51622
Estimated Expiration: ⤷  Try a Trial

Patent: 49301
Estimated Expiration: ⤷  Try a Trial

Patent: 12379
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 52205
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7048
Estimated Expiration: ⤷  Try a Trial

Patent: 5982
Estimated Expiration: ⤷  Try a Trial

Patent: 7491
Estimated Expiration: ⤷  Try a Trial

Patent: 4237
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 16285
Estimated Expiration: ⤷  Try a Trial

Patent: 73491
Estimated Expiration: ⤷  Try a Trial

Patent: 73522
Estimated Expiration: ⤷  Try a Trial

Patent: 20500906
Estimated Expiration: ⤷  Try a Trial

Patent: 21119172
Estimated Expiration: ⤷  Try a Trial

Patent: 21512117
Estimated Expiration: ⤷  Try a Trial

Patent: 23154048
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 0190125
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 51622
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 19006637
Estimated Expiration: ⤷  Try a Trial

Patent: 20007853
Estimated Expiration: ⤷  Try a Trial

Patent: 21013639
Estimated Expiration: ⤷  Try a Trial

Moldova, Republic of

Patent: 51622
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 235
Estimated Expiration: ⤷  Try a Trial

Patent: 739
Estimated Expiration: ⤷  Try a Trial

Patent: 847
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4805
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 191304
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 51622
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 20129238
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 9401947
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 150
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201913606V
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 51622
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1904062
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2269492
Estimated Expiration: ⤷  Try a Trial

Patent: 190101993
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 37431
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 74712
Estimated Expiration: ⤷  Try a Trial

Patent: 10243
Estimated Expiration: ⤷  Try a Trial

Patent: 1835065
Estimated Expiration: ⤷  Try a Trial

Patent: 1944994
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 513
Estimated Expiration: ⤷  Try a Trial

Patent: 723
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRIKAFTA (COPACKAGED) around the world.

Country Patent Number Title Estimated Expiration
Slovenia 2464337 ⤷  Try a Trial
France 21C1018 ⤷  Try a Trial
European Patent Office 2532650 Modulateurs de transporteurs de cassette de liaison à l ́ATP (Modulators of ATP-binding cassette transporters) ⤷  Try a Trial
Japan 2012056962 MODULATOR OF ATP-BINDING CASSETTE TRANSPORTER ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRIKAFTA (COPACKAGED)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2826776 C202130026 Spain ⤷  Try a Trial PRODUCT NAME: UNA COMBINACION DE (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-IL)-N-(1-(2,3-DIHIDROXIPROPIL)-6-FLUORO-2-(1-HIDROXI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL)CICLOPROPANOCARBOXAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO Y(B) N-(5-HIDROXI-2,4-DITERT-BUTIL-FENIL)-4-OXO-1HQUINOLIN-3-CARBOXAMIDA O UNA SALFARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1306; DATE OF AUTHORISATION: 20181031; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1306; DATE OF FIRST AUTHORISATION IN EEA: 20181031
1773816 300748 Netherlands ⤷  Try a Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816 C01773816/01 Switzerland ⤷  Try a Trial PRODUCT NAME: IVACAFTOR; REGISTRATION NO/DATE: SWISSMEDIC 62686 13.01.2014
2826776 2021C/517 Belgium ⤷  Try a Trial PRODUCT NAME: SYMKEVI - TEZACAFTOR/IVACAFTOR; EEN COMBINATIE VAN (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.