TRIKAFTA (COPACKAGED) Drug Patent Profile
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Which patents cover Trikafta (copackaged), and when can generic versions of Trikafta (copackaged) launch?
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 five hundred and one patent family members in forty-five 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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Questions you can ask:
- What is the 5 year forecast for TRIKAFTA (COPACKAGED)?
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Summary for TRIKAFTA (COPACKAGED)
| International Patents: | 501 |
| US Patents: | 32 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRIKAFTA (COPACKAGED) |
| DailyMed Link: | TRIKAFTA (COPACKAGED) at DailyMed |
-patent-expirations.png "TRIKAFTA (COPACKAGED) drug patent expirations")
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRIKAFTA (COPACKAGED)
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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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
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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
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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
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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
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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
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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
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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Patent Expiration: ⤷ Sign Up
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
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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
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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
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO
Pharmaceutical composition and administrations thereof
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Modulators of cystic fibrosis transmembrane conductance regulator
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of cystic fibrosis transmembrane conductance regulator
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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
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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
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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
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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
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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
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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
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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
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO
Pharmaceutical compositions for treating cystic fibrosis
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Pharmaceutical compositions for treating cystic fibrosis
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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
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of cystic fibrosis transmembrane conductance regulator
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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
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Methods of treatment for cystic fibrosis
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Methods of treatment for cystic fibrosis
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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
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO
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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
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO
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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
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
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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
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Patented Use: TREATMENT OF CF IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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Indole derivatives as CFTR modulators
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Modulators of ATP-binding cassette transporters
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Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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Patent Expiration: ⤷ Sign Up
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
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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
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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
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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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
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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
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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
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Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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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
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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
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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
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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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
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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
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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
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Modulators of ATP-binding cassette transporters
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Patented Use: TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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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
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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
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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
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Pharmaceutical composition and administrations thereof
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 2 TO
Modulators of ATP-binding cassette transporters
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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
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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
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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: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
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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
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
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
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
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, COMPOSICIONES FARMACÉUTICAS, MÉTODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 17371200
Patent: Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Estimated Expiration: ⤷ Sign Up
Patent: 21211993
Patent: MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR
Estimated Expiration: ⤷ Sign Up
Patent: 23203944
Patent: MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2019011626
Patent: modulador de regulador de condutância transmembrana na fibrose cística, composições farmacêuticas, métodos de tratamento e processo para a produção do modulador
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 46086
Patent: MODULATEUR DE REGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE FIBROSE KYSTIQUE, COMPOSITIONS PHARMACEUTIQUES, PROCEDES DE TRAITEMENT ET PROCEDE DE FABRICATION DU MODULATEUR (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 19001553
Patent: Modulador del regulador de conductancia transmembrana de fibrosis quística, composiciones farmacéuticas, métodos de tratamiento y proceso para producir el modulador.
Estimated Expiration: ⤷ Sign Up
China
Patent: 0267948
Patent: 囊性纤维化跨膜传导调控剂的调节剂、药物组合物、治疗方法和制备所述调节剂的方法 (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷ Sign Up
Patent: 7843619
Patent: 囊性纤维化跨膜传导调控剂的调节剂、药物组合物、治疗方法和制备所述调节剂的方法
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 19007129
Patent: Modulador del regulador de conductancia transmembrana de fibrosis quística, composiciones farmacéuticas, métodos de tratamiento y proceso para producir el modulador
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0201946
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 23736
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 51622
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 19048759
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA DE TRANSMEMBRANA DE FIBROSIS QUÍSTICA, COMPOSICIONES FARMACÉUTICAS, Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 9280
Patent: МОДУЛЯТОР РЕГУЛЯТОРА ТРАНСМЕМБРАННОЙ ПРОВОДИМОСТИ ПРИ МУКОВИСЦИДОЗЕ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СПОСОБЫ ЛЕЧЕНИЯ И СПОСОБ ПОЛУЧЕНИЯ УКАЗАННОГО МОДУЛЯТОРА (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷ Sign Up
Patent: 1991403
Patent: МОДУЛЯТОР РЕГУЛЯТОРА ТРАНСМЕМБРАННОЙ ПРОВОДИМОСТИ ПРИ МУКОВИСЦИДОЗЕ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СПОСОБЫ ЛЕЧЕНИЯ И СПОСОБ ПОЛУЧЕНИЯ УКАЗАННОГО МОДУЛЯТОРА
Estimated Expiration: ⤷ Sign Up
Patent: 2192783
Patent: МОДУЛЯТОР РЕГУЛЯТОРА ТРАНСМЕМБРАННОЙ ПРОВОДИМОСТИ ПРИ МУКОВИСЦИДОЗЕ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СПОСОБЫ ЛЕЧЕНИЯ И СПОСОБ ПОЛУЧЕНИЯ УКАЗАННОГО МОДУЛЯТОРА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 51622
Patent: MODULATEUR DE RÉGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE FIBROSE KYSTIQUE, COMPOSITIONS PHARMACEUTIQUES, PROCÉDÉS DE TRAITEMENT ET PROCÉDÉ DE FABRICATION DU MODULATEUR (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷ Sign Up
Patent: 12379
Patent: FORME CRYSTALLINE D'UN N-(PYRAZOL-4-YL)SULFONYL-6-(PYRAZOL-1-YL)-2-(PYRROLIDIN-1-YL)PYRIDINE-3-CARBOXAMIDE POUR TRAITER LA MUCOVISCIDOSE (CRYSTALLINE FORM OF A N-(PYRAZOL-4-YL)SULFONYL-6-(PYRAZOL-1-YL)-2-(PYRROLIDIN-1-YL)PYRIDINE-3-CARBOXAMIDE FOR TREATING CYSTIC FIBROSIS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 52205
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7048
Patent: אפנן וסת של מוליכות טראנסממברנלית בציסטיק פיברוזיס, תכשירים פרמצבטים, שיטות טיפול, ותהליך ליצירת האפנן (Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator)
Estimated Expiration: ⤷ Sign Up
Patent: 7491
Patent: אפנן וסת של מוליכות טראנסממברנלית בציסטיק פיברוזיס, תכשירים פרמצבטים, שיטות טיפול, ותהליך ליצירת האפנן (Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator)
Estimated Expiration: ⤷ Sign Up
Patent: 4237
Patent: אפנן וסת של מוליכות טראנסממברנלית בציסטיק פיברוזיס, תכשירים פרמצבטים, שיטות טיפול, ותהליך ליצירת האפנן (Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 16285
Estimated Expiration: ⤷ Sign Up
Patent: 73522
Estimated Expiration: ⤷ Sign Up
Patent: 20500906
Patent: 嚢胞性線維症膜コンダクタンス制御因子の調節物質、医薬組成物、治療方法、及び調節物質の作製プロセス
Estimated Expiration: ⤷ Sign Up
Patent: 21119172
Patent: 嚢胞性線維症膜コンダクタンス制御因子の調節物質、医薬組成物、治療方法、及び調節物質の作製プロセス (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING MODULATOR)
Estimated Expiration: ⤷ Sign Up
Patent: 23154048
Patent: 嚢胞性線維症膜コンダクタンス制御因子の調節物質、医薬組成物、治療方法、及び調節物質の作製プロセス (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING MODULATOR)
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 0190125
Patent: مُعدِّل لمنظم موصلية التليف الكيسي عبر الغشاء، وتركيبات صيدلانية، وطرق للعلاج، وعملية لتصنيع المُعدِّل (Modulator of Cystic Fibrosis Transmembrane Conductance Regulator, Pharmaceutical Compositions, Methods of Treatment, and Process for Making the Modulator)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 51622
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 19006637
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUISTICA COMPOSICIONES FARMACEUTICAS METODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR. (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR.)
Estimated Expiration: ⤷ Sign Up
Patent: 21013639
Patent: FORMA CRISTALINA DEL COMPUESTO 1, UN MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, PROCESOS PARA SU PREPARACIÓN, COMPOSICIONES FARMACÉUTICAS DEL COMPUESTO 1, Y SU USO EN EL TRATAMIENTO DE FIBROSIS QUÍSTICA. (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR.)
Estimated Expiration: ⤷ Sign Up
Moldova, Republic of
Patent: 51622
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 235
Patent: MODULATEUR DE RÉGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE FIBROSE KYSTIQUE, COMPOSITIONS PHARMACEUTIQUES, PROCÉDÉS DE TRAITEMENT ET PROCÉDÉ DE FABRICATION DU MODULATEUR
Estimated Expiration: ⤷ Sign Up
Patent: 847
Patent: FORME CRYSTALLINE D'UN N-(PYRAZOL-4-YL)SULFONYL-6-(PYRAZOL-1-YL)-2-(PYRROLIDIN-1-YL)PYRIDINE-3-CARBOXAMIDE POUR TRAITER LA MUCOVISCIDOSE
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 4805
Patent: Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 191304
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA DE TRANSMEMBRANA DE FIBROSIS QUISTICA, COMPOSICIONES FARMACEUTICAS, METODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 51622
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 9401947
Patent: مُعدِّل منظم التوصيل عبر الأغشية للتليف الكيسي، تركيبات صيدلية، طرق علاج، وعملية لتحضير المُعدِّل (Modulator of Cystic Fibrosis Transmembrane Conductance Regulator, Pharmaceutical Compositions, Methods of Treatment, and Process for Making the Modulator)
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 150
Patent: MODULATOR REGULATORA TRANSMEMBRANSKE PROVODLJIVOSTI CISTIČNE FIBROZE, FARMACEUTSKE KOMPOZICIJE, POSTUPCI LEČENJA, I POSTUPAK ZA DOBIJANJE MODULATORA (MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201913606V
Patent: MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 51622
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1904062
Patent: MODULATOR OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR, PHARMACEUTICAL COMPOSITIONS, METHODS OF TREATMENT, AND PROCESS FOR MAKING THE MODULATOR
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2269492
Estimated Expiration: ⤷ Sign Up
Patent: 190101993
Patent: 낭포성 섬유증 막관통 전도성 조절인자의 조절제, 약제학적 조성물, 치료 방법, 및 상기 조절제를 제조하는 방법
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 37431
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 74712
Estimated Expiration: ⤷ Sign Up
Patent: 1835065
Patent: Modulator of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 513
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, COMPOSICIONES FARMACÉUTICAS, MÉTODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷ Sign Up
Patent: 723
Patent: MODULADOR DEL REGULADOR DE CONDUCTANCIA TRANSMEMBRANA DE FIBROSIS QUÍSTICA, COMPOSICIONES FARMACÉUTICAS, MÉTODOS DE TRATAMIENTO Y PROCESO PARA PRODUCIR EL MODULADOR
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| China | 102892764 | Solid forms of (r)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-n-(1-(2,3-dihyderoxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1h-indol-5-yl) cyclopropanecarboxamide | ⤷ Sign Up |
| Japan | 2021138751 | 嚢胞性線維症膜貫通コンダクタンス制御因子のモジュレーター (MODULATORS OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR) | ⤷ Sign Up |
| Japan | 2012056962 | MODULATOR OF ATP-BINDING CASSETTE TRANSPORTER | ⤷ Sign Up |
| Cyprus | 1116116 | ⤷ Sign Up | |
| Lithuania | 2328618 | ⤷ Sign Up | |
| Cyprus | 1119945 | ⤷ Sign Up | |
| Hong Kong | 1205690 | 藥物组合物及其施用 (PHARMACEUTICAL COMPOSITION AND ADMINISTRATION THEREOF) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TRIKAFTA (COPACKAGED)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2826776 | 132021000000062 | Italy | ⤷ Sign Up | PRODUCT NAME: UNA COMBINAZIONE DI (A) TEZACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E (B) IVACAFTOR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SYMKEVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1306, 20181106 |
| 2826776 | LUC00207 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF (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 OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106 |
| 1773816 | C20150028 00162 | Estonia | ⤷ Sign Up | PRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012 |
| 2826776 | 13/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: 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 UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYLPHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID; REGISTRATION NO/DATE: EU/1/18/1306 (MITTEILUNG) 20181106 |
| 2826776 | CR 2021 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: EN KOMBINATION AF (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)CYCLOPROPANECARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) ....; REG. NO/DATE: EU/1/18/1306 20181106 |
| 1773816 | 35/2015 | Austria | ⤷ Sign Up | 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 |
| 2826776 | 2021C/517 | Belgium | ⤷ Sign Up | 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.
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