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Last Updated: January 28, 2022

DrugPatentWatch Database Preview

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 one NDA. There are twenty-one patents protecting this drug.

This drug has four hundred and eighteen patent family members in forty-two 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) will be eligible for patent challenges on October 21, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for TRIKAFTA (COPACKAGED)
International Patents:418
US Patents:21
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:TRIKAFTA (COPACKAGED) at DailyMed
Drug patent expirations by year for TRIKAFTA (COPACKAGED)
DrugPatentWatch® Estimated Generic Entry Opportunity Date for TRIKAFTA (COPACKAGED)
Generic Entry Date for TRIKAFTA (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, TABLET;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 forty-seven US patents and six FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Modulators of cystic fibrosis transmembrane conductance regulator
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Indole derivatives as CFTR modulators
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free 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)

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign up for a Free Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign up for a Free Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free 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: ⤷  Sign up for a Free 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 212273-001 Oct 21, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y Y ⤷  Sign up for a Free Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor TABLET;ORAL 212273-001 Oct 21, 2019 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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)

Country Patent Number Estimated Expiration
Russian Federation 2573830 ⤷  Sign up for a Free Trial
Cyprus 1119963 ⤷  Sign up for a Free Trial
Japan 2012107069 ⤷  Sign up for a Free Trial
Norway 2021021 ⤷  Sign up for a Free Trial
Croatia P20201603 ⤷  Sign up for a Free Trial
Singapore 10201913603Q ⤷  Sign up for a Free Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for TRIKAFTA (COPACKAGED)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2826776 122021000025 Germany ⤷  Sign up for a Free Trial PRODUCT NAME: EINE KOMBINATION VON (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANCARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1306 20181031
1773816 1590036-8 Sweden ⤷  Sign up for a Free Trial PRODUCT NAME: N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/12/782/001 20120725
1773816 PA2015028 Lithuania ⤷  Sign up for a Free Trial PRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
1773816 35/2015 Austria ⤷  Sign up for a Free Trial PRODUCT NAME: N-(5-HYDROXY-2,4DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001, EU/1/12/782/002 (MITTEILUNG) 20120725
1773816 15C0045 France ⤷  Sign up for a Free Trial PRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
1773816 CA 2015 00038 Denmark ⤷  Sign up for a Free Trial PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
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