Generic Alyftrek Availability

Last updated on Apr 10, 2025.

Alyftrek is a brand name of deutivacaftor/tezacaftor/vanzacaftor, approved by the FDA in the following formulation(s):

ALYFTREK (deutivacaftor; tezacaftor; vanzacaftor calcium - tablet;oral)

Manufacturer: VERTEX PHARMS INC
Approval date: December 20, 2024
Strength(s): 50MG;20MG;EQ 4MG BASE ^[RLD], 125MG;50MG;EQ 10MG BASE ^[RLD]

Is there a generic version of Alyftrek available?

No. There is currently no therapeutically equivalent version of Alyftrek available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Alyftrek. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Modulators of ATP-binding cassette transporters
Patent 10,022,352
Issued: July 17, 2018
Inventor(s): Hadida Ruah Sara Sabina & Grootenhuis Peter Diederik Jan & Van Goor Fredrick F. & Zhou Jinglan & Bear Brian Richard & Miller Mark Thomas & McCartney Jason & Numa Mehdi Michel Djamel
Assignee(s): Vertex Pharmaceuticals Incorporated
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- April 9, 2027
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  Patent 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 VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
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Deuterated CFTR potentiators
Patent 10,047,053
Issued: August 14, 2018
Inventor(s): Morgan; Adam J.
Assignee(s): Vertex Pharmaceuticals (Europe) Limited (London, GB)
This invention relates to compounds of Formula I: ##STR00001##
and pharmaceutically acceptable salts thereof. This invention also provides compositions comprising a compound of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering a CFTR potentiator.
Patent expiration dates:
- May 17, 2032
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Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof
Patent 10,058,546
Issued: August 28, 2018
Inventor(s): Alargova Rossitza Gueorguieva & Dunbar Craig Antony & Kadiyala Irina Nikolaevna
Assignee(s): Vertex Pharmaceuticals Incorporated
A pharmaceutical composition comprising Compound 1, (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, and at least one excipient selected from: a filler, a disintegrant, a surfactant, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering the pharmaceutical composition of Compound 1 are also disclosed.
Patent expiration dates:
- July 15, 2033
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  Patent use: TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WITH AT LEAST ONE F508DEL OR G551D AND AN A455E, 2789+5G->A, OR 3849+10KBC->T CFTR MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546 FURTHER COMPRISING VNZ
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)cyclopropanecarboxamide
Patent 10,081,621
Issued: September 25, 2018
Inventor(s): Keshavarz-Shokri Ali & Zhang Beili & Alcacio Tim Edward & Lee Elaine Chungmin & Zhang Yuegang & Krawiec Mariusz
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates 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)cyclopropanecarboxamide (Compound 1) in substantially crystalline form (Form A) or amorphous form, pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- March 25, 2031
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ, D-IVA, AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10081621
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Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent 10,206,877
Issued: February 19, 2019
Inventor(s): Phenix Brian Dean & Bagnol Laurent Jean-Claude & Brodeur Geoffrey Glen & Chandran Sachin & Dokou Eleni & Ferris Lori Ann & Knezic Dragutin & McCarty Katie Lynn & Medek Ales & Waggener Sara A.
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention features compositions comprising a plurality of therapeutic agents wherein the presence of one therapeutic agent enhances the properties of at least one other therapeutic agent. In one embodiment, the therapeutic agents are cystic fibrosis transmembrane conductance regulators (CFTR) such as a CFTR corrector or CFTR potentiator for the treatment of CFTR mediated diseases such as cystic fibrosis. Methods and kits thereof are also disclosed.
Patent expiration dates:
- April 14, 2035
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ AND A COMPOSITION ACCORDING TO CLAIM 1 OF US10206877
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Modulators of ATP-binding cassette transporters
Patent 10,239,867
Issued: March 26, 2019
Inventor(s): Hadida Ruah Sara S. & Grootenhuis Peter D. J. & Van Goor Fredrick & Zhou Jinglan & Bear Brian & Miller Mark T. & McCartney Jason & Numa Mehdi Michel Jamel & Yang Xiaoqing
Assignee(s): Vertex Pharmaceuticals Incorporated
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- April 9, 2027
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
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Pharmaceutical composition and administrations thereof
Patent 10,646,481
Issued: May 12, 2020
Inventor(s): Rowe William & Hurter Patricia & Young Christopher & Dinehart Kirk & Verwijs Marinus Jacobus & Overhoff Kirk & Grootenhuis Peter D. J. & Botfield Martyn & Grossi Alfredo
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Patent expiration dates:
- August 13, 2029
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  Drug product
Modulators of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators
Patent 11,066,417
Issued: July 20, 2021
Inventor(s): Clemens; Jeremy J. et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
Compounds of Formula (I): ##STR00001##
pharmaceutically acceptable salts thereof, deuterated derivatives of any of the foregoing, and metabolites of any of the foregoing are disclosed. Pharmaceutical compositions comprising the same, methods of treating cystic fibrosis using the same, and methods for making the same are also disclosed.
Patent expiration dates:
- February 14, 2039
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Pharmaceutical composition and administrations thereof
Patent 11,564,916
Issued: January 31, 2023
Inventor(s): Rowe; William et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.
Patent expiration dates:
- August 13, 2029
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US11564916, VNZ, AND TEZ
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)cyclopropanecarboxamide
Patent 11,578,062
Issued: February 14, 2023
Inventor(s): Keshavarz-Shokri; Ali et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates 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)cyclopropanecarboxamide (Compound 1) in substantially crystalline form (Form A) or amorphous form, pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- March 25, 2031
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, DEUTIVACAFTOR, AND A SOLID DISPERSION ACCORDING TO CLAIM 1 OF US 11,578,062
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  Drug product
Modulators of ATP-binding cassette transporters
Patent 11,639,347
Issued: May 2, 2023
Inventor(s): Hadida Ruah; Sara S. et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- April 9, 2027
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
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Modulators of Cystic Fibrosis Transmembrane Conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators
Patent 11,866,450
Issued: January 9, 2024
Inventor(s): Clemens; Jeremy J. et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
Compounds of Formula (I): ##STR00001##
pharmaceutically acceptable salts thereof, deuterated derivatives of any of the foregoing, and metabolites of any of the foregoing are disclosed. Pharmaceutical compositions comprising the same, methods of treating cystic fibrosis using the same, and methods for making the same are also disclosed.
Patent expiration dates:
- February 14, 2039
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Crystalline forms of CFTR modulators
Patent 11,873,300
Issued: January 16, 2024
Inventor(s): Shi; Yi et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
Crystalline forms of Compound I: ##STR00001##
pharmaceutically acceptable salts thereof, and solvates and hydrates thereof are disclosed. Pharmaceutical compositions comprising the same, methods of treating cystic fibrosis using the same, and methods for making the same are also disclosed.
Patent expiration dates:
- August 13, 2040
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR CALCIUM SALT HYDRATE FORM D, TEZACAFTOR, AND DEUTIVACAFTOR
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Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent 11,951,212
Issued: April 9, 2024
Inventor(s): Phenix; Brian Dean et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention features compositions comprising a plurality of therapeutic agents wherein the presence of one therapeutic agent enhances the properties of at least one other therapeutic agent. In one embodiment, the therapeutic agents are cystic fibrosis transmembrane conductance regulators (CFTR) such as a CFTR corrector or CFTR potentiator for the treatment of CFTR mediated diseases such as cystic fibrosis. Methods and kits thereof are also disclosed.
Patent expiration dates:
- April 14, 2035
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VNZ AND A COMPOSITION ACCORDING TO CLAIM 1 OF US11951212
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Methods of treatment for cystic fibrosis
Patent 12,186,306
Issued: January 7, 2025
Inventor(s): Borek; Bartlomiej et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
This application describes methods of treating cystic fibrosis or a CFTR mediated disease comprising administering Compound I or a pharmaceutically acceptable salt thereof. ##STR00001##
The application also describes pharmaceutical compositions comprising Compound I or a pharmaceutically acceptable salt thereof and optionally comprising one or more additional CFTR modulating agents.
Patent expiration dates:
- January 10, 2043
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  Patent use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH 21.4 MG OF VNZ CALCIUM SALT HYDRATE FORM D, 100 MG OF TEZ, AND 250 MG OF D-IVA DAILY
Modulators of ATP-binding cassette transporters
Patent 7,495,103
Issued: February 24, 2009
Inventor(s): Hadida-Ruah; Sara et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Cambridge, MA)
The present invention relates to modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- May 20, 2027
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Indole derivatives as CFTR modulators
Patent 7,645,789
Issued: January 12, 2010
Inventor(s): Hadida Ruah; Sara S. et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Cambridge, MA)
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator ("CFTR"). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- May 1, 2027
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Modulators of ATP-binding cassette transporters
Patent 7,776,905
Issued: August 17, 2010
Inventor(s): Hadida Ruah; Sara S. et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Cambridge, MA)
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette ("ABC") transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator ("CFTR"). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- June 3, 2027
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Modulators of ATP-binding cassette transporters
Patent 8,324,242
Issued: December 4, 2012
Inventor(s): Ruah Sara Hadida & Hazlewood Anna & Grootenhuis Peter D. J. & Van Goor Fredrick & Singh Ashvani & Zhou Jinglan & McCartney Jason
Assignee(s): Vertex Pharmaceutical Incorporated
The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- August 5, 2027
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Modulators of ATP-binding cassette transporters
Patent 8,354,427
Issued: January 15, 2013
Inventor(s): Van Goor Fredrick
Assignee(s): Vertex Pharmaceutical Incorporated
The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- July 6, 2026
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 8,410,274
Issued: April 2, 2013
Inventor(s): Hurter Patricia & Rowe William & Young Christopher Ryan & Costache Adriana & Connelly Patrick R. & Krawiec Mariusz & Gong Yuchuan & Feng Yushi & Trudeau Martin
Assignee(s): Vertex Pharmaceuticals
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- December 28, 2026
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Modulators of ATP-binding cassette transporters
Patent 8,415,387
Issued: April 9, 2013
Inventor(s): Ruah Sara S. Hadida & Grootenhuis Peter D. J. & Miller Mark T & McCartney Jason & van Goor Fredrick & Numa Mehdi Michel Djamel & Zhou Jinglan & Bear Brian
Assignee(s): Vertex Pharmaceuticals Incorporated
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- November 12, 2027
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Modulators of ATP-binding cassette transporters
Patent 8,598,181
Issued: December 3, 2013
Inventor(s): Hadida Ruah Sara S. & Grootenhuis Peter D. J. & Van Goor Fredrick & Zhou Jinglan & Bear Brian & Miller Mark T. & McCartney Jason & Numa Mehdi Michel Jamel & Yang Xiaoqing
Assignee(s): Vertex Pharmaceuticals Incorporated
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- May 1, 2027
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
Modulators of ATP-binding cassette transporters
Patent 8,623,905
Issued: January 7, 2014
Inventor(s): Ruah Sara S. Hadida & Grootenhuis Peter D. J. & van Goor Fredrick F. & Zhou Jinglan & Bear Brian & Miller Mark T. & McCartney Jason & Numa Mehdi Michel Djamel
Assignee(s): Vertex Pharmaceuticals Incorporated
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFFR”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- May 1, 2027
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Modulators of ATP-binding cassette transporters
Patent 8,629,162
Issued: January 14, 2014
Inventor(s): Hadida-Ruah Sara & Hazlewood Anna & Grootenhuis Peter D. J. & Van Goor Fredrick & Singh Ashvani & Zhou Jinglan & McCartney Jason
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator, compositions thereof, and methods therewith. The present invention also relates to methods of treating ABC transporter mediated diseases using such modulators.
Patent expiration dates:
- June 24, 2025
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  Patent 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 OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AND D-IVA
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 8,754,224
Issued: June 17, 2014
Inventor(s): Hurter Patricia & Rowe William & Young Christopher R. & Costache Adriana & Connelly Patrick R. & Krawlec Mariusz & Gong Yuchuan & Feng Yushi & Trudeau Martin
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- December 28, 2026
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Deuterated CFTR potentiators
Patent 8,865,902
Issued: October 21, 2014
Inventor(s): Morgan; Adam J.
Assignee(s): Concert Pharmaceuticals, Inc. (Lexington, MA)
This invention relates to compounds of Formula I: ##STR00001## and pharmaceutically acceptable salts thereof. This invention also provides compositions comprising a compound of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering a CFTR potentiator.
Patent expiration dates:
- May 17, 2032
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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)cyclopropanecarboxamide and administration thereof
Patent 9,012,496
Issued: April 21, 2015
Inventor(s): Alargova Rossitza Gueorguieva & Dunbar Craig Antony & Kadiyala Irina Nikolaevna
Assignee(s): Vertex Pharmaceuticals Incorporated
A pharmaceutical composition comprising Compound 1, (R)-1-(2,2-difluorobenzo[d][1,3]dioxo-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide, and at least one excipient selected from: a filler, a disintegrant, a surfactant, a glidant and a lubricant, the composition being suitable for oral administration to a patient in need thereof to treat a CFTR mediated disease such as Cystic Fibrosis. Methods for treating a patient in need thereof include administering the pharmaceutical composition of Compound 1 are also disclosed.
Patent expiration dates:
- July 15, 2033
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 9,012,496 FURTHER COMPRISING VNZ
Deuterated CFTR potentiators
Patent 9,181,192
Issued: November 10, 2015
Inventor(s): Morgan; Adam J.
Assignee(s): Concert Pharmaceuticals, Inc. (Lexington, MA)
This invention relates to compounds of Formula I: ##STR00001##
and pharmaceutically acceptable salts thereof. This invention also provides compositions comprising a compound of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering a CFTR potentiator.
Patent expiration dates:
- May 17, 2032
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  Patent use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING VNZ, TEZ, AND D-IVA WITH AT LEAST 90% ISOTOPIC ENRICHMENT FOR EACH DEUTERIUM ATOM
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Deuterated CFTR potentiators
Patent 9,512,079
Issued: December 6, 2016
Inventor(s): Morgan; Adam J.
Assignee(s): Concert Pharmaceuticals, Inc. (Lexington, MA)
This invention relates to compounds of Formula I: ##STR00001##
and pharmaceutically acceptable salts thereof. This invention also provides compositions comprising a compound of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering a CFTR potentiator.
Patent expiration dates:
- May 17, 2032
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  Patent use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF VNZ, TEZ, AND A COMPOSITION ACCORDING TO CLAIM 3 OF US 9,512,079
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Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 9,670,163
Issued: June 6, 2017
Inventor(s): Hurter Patricia & Rowe William & Young Christopher R. & Costache Adriana & Connelly Patrick R. & Krawiec Mariusz & Gong Yuchuan & Feng Yushi & Trudeau Martin
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- December 28, 2026
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  Patent use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA
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  Drug product
Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 9,931,334
Issued: April 3, 2018
Inventor(s): Hurter Patricia & Rowe William & Young Christopher R. & Costache Adriana & Connelly Patrick R. & Krawiec Mariusz & Gong Yuchuan & Feng Yushi & Trudeau Martin
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to solid state forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide (Compound 1), pharmaceutical compositions thereof and methods therewith.
Patent expiration dates:
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CF IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH A SOLID PHARMACEUTICAL COMPOSITION COMPRISING VNZ, TEZ, AMORPHOUS D-IVA, AND <30% CRYSTALLINE D-IVA
  ✓
  Drug product
Modulators of ATP-binding cassette transporters
Patent 9,974,781
Issued: May 22, 2018
Inventor(s): Hadida Ruah Sara Sabina & Grootenhuis Peter Diederik Jan & Van Goor Fredrick F. & Zhou Jinglan & Bear Brian Richard & Miller Mark Thomas & McCartney Jason & Numa Mehdi Michel Djamel
Assignee(s): Vertex Pharmaceuticals Incorporated
Compounds of the present invention and pharmaceutically acceptable compositions thereof, are useful as modulators of ATP-Binding Cassette (“ABC”) transporters or fragments thereof, including Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- April 9, 2027
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR ANOTHER RESPONSIVE MUTATION IN THE CFTR GENE WITH VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR
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  Drug product

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- December 20, 2029 - NEW CHEMICAL ENTITY

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

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Drug Status

Availability Prescription only Rx

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill V4 is Alyftrek deutivacaftor 50 mg / tezacaftor 20 mg / vanzacaftor 4 mg — Alyftrek deutivacaftor 50 mg / tezacaftor 20 mg / vanzacaftor 4 mg (V4)