Generic Orkambi Availability

Last updated on Apr 10, 2025.

Orkambi is a brand name of ivacaftor/lumacaftor, approved by the FDA in the following formulation(s):

ORKAMBI (ivacaftor; lumacaftor - granule;oral)

Manufacturer: VERTEX PHARMS INC
Approval date: August 7, 2018
Strength(s): 125MG/PACKET;100MG/PACKET ^[RLD], 188MG/PACKET;150MG/PACKET ^[RLD]
Manufacturer: VERTEX PHARMS INC
Approval date: September 2, 2022
Strength(s): 94MG/PACKET;75MG/PACKET ^[RLD]

ORKAMBI (ivacaftor; lumacaftor - tablet;oral)

Manufacturer: VERTEX PHARMS INC
Approval date: July 2, 2015
Strength(s): 125MG;200MG ^[RLD]
Manufacturer: VERTEX PHARMS INC
Approval date: September 28, 2016
Strength(s): 125MG;100MG ^[RLD]

Is there a generic version of Orkambi available?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Orkambi. 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.

Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Patent 10,076,513
Issued: September 18, 2018
Inventor(s): Verwijs Marinus Jacobus & Alargova Rossitza Gueorguieva & Kaushik Ritu Rohit & Kadiyala Irina Nikolaevna & Young Christopher
Assignee(s): Vertex Pharmaceuticals Incorporated
A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a diluent, a disintegrant, a surfactant, a binder, 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 an oral pharmaceutical formulation of Compound 1 to the patient.
Patent expiration dates:
- December 4, 2028
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 12 YEARS OR OLDER WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE TABLET COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1, 19, OR 21 OF U.S. PATENT NO. 10,076,513 AND IVACAFTOR
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Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Patent 10076513*PE
Issued: September 18, 2018
Inventor(s): Verwijs; Marinus Jacobus et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a diluent, a disintegrant, a surfactant, a binder, 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 an oral pharmaceutical formulation of Compound 1 to the patient.
Patent expiration dates:
- June 4, 2029
Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent 10,597,384
Issued: March 24, 2020
Inventor(s): Keshavarz-Shokri Ali & Zhang Beili & Krawiec Mariusz
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methypyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- December 4, 2028
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
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- December 4, 2028
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 2 TO 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
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- December 4, 2028
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
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Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent 10597384*PE
Issued: March 24, 2020
Inventor(s): Keshavarz-Shokri; Ali et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methypyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- June 4, 2029
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
Pharmaceutical composition and administrations thereof
Patent 10646481*PE
Issued: May 12, 2020
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:
- February 13, 2030
Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Patent 11,052,075
Issued: July 6, 2021
Inventor(s): Verwijs Marinus Jacobus & Alargova Rossitza Gueorguieva & Kaushik Ritu Rohit & Kadiyala Irina Nikolaevna & Young Christopher
Assignee(s): Vertex Pharmaceuticals Incorporated
A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo [d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a diluent, a disintegrant, a surfactant, a binder, 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 an oral pharmaceutical formulation of Compound 1 to the patient.
Patent expiration dates:
- December 4, 2028
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE TABLET ACCORDING TO CLAIM 1 OF U.S. PATENT NO. 11,052,075, WHERE THE TABLET FURTHER COMPRISES IVACAFTOR
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  Drug product
Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Patent 11052075*PE
Issued: July 6, 2021
Inventor(s): Verwijs; Marinus Jacobus et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
A pharmaceutical composition comprising Compound 1, (3-(6-(1-(2,2-difluorobenzo [d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid), and at least one excipient selected from: a filler, a diluent, a disintegrant, a surfactant, a binder, 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 an oral pharmaceutical formulation of Compound 1 to the patient.
Patent expiration dates:
- June 4, 2029
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
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  Patent use: TREATMENT OF CF IN A PATIENT AGE 1 TO <6 YEARS AND WEIGHING 7 KG OR MORE WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
- August 13, 2029
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  Patent use: TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE COMPOSITION RECITED IN CLAIM 1 OF US 11564916
Pharmaceutical composition and administrations thereof
Patent 11564916*PE
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:
- February 13, 2030
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent 12,065,432
Issued: August 20, 2024
Inventor(s): Keshavarz-Shokri; Ali et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- December 4, 2028
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 1 YEAR TO 5 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AND FORM I LUM AS RECITED IN, E.G., CLAIM 1 OF US 12065432
- December 4, 2028
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL CFTR GENE MUTATION COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF IVA AND FORM I LUM AS RECITED IN, E.G., CLAIM 1 OF US 12065432
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent 12065432*PE
Issued: August 20, 2024
Inventor(s): Keshavarz-Shokri; Ali et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- June 4, 2029
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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Modulators of ATP-binding cassette transporters
Patent 7495103*PED
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:
- November 20, 2027
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  Pediatric exclusivity
Modulators of ATP-binding cassette transporters
Patent 7,973,038
Issued: July 5, 2011
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:
- November 8, 2026
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
- November 8, 2026
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
- November 8, 2026
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS USING N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE AND 3-(6-(1-2,2-DIFLUOROBENZO[D][1,3]DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID
Modulators of ATP-binding cassette transporters
Patent 7973038*PED
Issued: July 5, 2011
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 8, 2027
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  Pediatric exclusivity
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 A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
- August 5, 2027
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
- August 5, 2027
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  Patent use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR
- August 5, 2027
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS
Modulators of ATP-binding cassette transporters
Patent 8324242*PED
Issued: December 4, 2012
Inventor(s): Ruah; Sara Hadida et al.
Assignee(s): Vertex Pharmaceutical 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:
- February 5, 2028
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  Pediatric exclusivity
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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Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent 8410274*PED
Issued: April 2, 2013
Inventor(s): Hurter; Patricia et al.
Assignee(s): Vertex Pharmaceuticals (Cambridge, MA)
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:
- June 28, 2027
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  Pediatric exclusivity
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent 8,507,534
Issued: August 13, 2013
Inventor(s): Keshavarz-Shokri Ali & Zhang Beili & Krawiec Mariusz
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- September 20, 2030
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Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent 8507534*PED
Issued: August 13, 2013
Inventor(s): Keshavarz-Shokri; Ali et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Cambridge, MA)
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- March 20, 2031
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  Pediatric exclusivity
Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent 8,653,103
Issued: February 18, 2014
Inventor(s): Keshavarz-Shokri Ali & Zhang Beili & Krawiec Mariusz
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- December 4, 2028
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  Drug product
Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent 8653103*PED
Issued: February 18, 2014
Inventor(s): Keshavarz-Shokri; Ali et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Cambridge, MA)
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- June 4, 2029
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  Pediatric exclusivity
Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent 8,716,338
Issued: May 6, 2014
Inventor(s): Young Christopher
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith.
Patent expiration dates:
- September 20, 2030
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR
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- September 20, 2030
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR
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- September 20, 2030
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING THE DOSAGE UNIT OF CLAIM 1 OF U.S. PATENT NO. 8,716,338
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  Drug product
- September 20, 2030
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE.
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  Drug product
Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent 8716338*PED
Issued: May 6, 2014
Inventor(s): Young; Christopher
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith.
Patent expiration dates:
- March 20, 2031
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  Pediatric exclusivity
Modulators of ATP-binding cassette transporters
Patent 8,741,933
Issued: June 3, 2014
Inventor(s): Hadida Ruah Sara S. & Hamilton Matthew & Miller Mark & Grootenhuis Peter D. J. & Bear Brian & McCartney Jason & Zhou Jinglan
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 8, 2026
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
- November 8, 2026
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND IVACAFTOR
- November 8, 2026
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND LUMACAFTOR
- November 8, 2026
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
Modulators of ATP-binding cassette transporters
Patent 8741933*PED
Issued: June 3, 2014
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:
- May 8, 2027
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  Pediatric exclusivity
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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  Drug substance
  ✓
  Drug product
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent 8754224*PED
Issued: June 17, 2014
Inventor(s): Hurter; Patricia et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
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:
- June 28, 2027
  ✓
  Pediatric exclusivity
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent 8,846,718
Issued: September 30, 2014
Inventor(s): Keshavarz-Shokri Ali & Zhang Beili & Krawiec Mariusz
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- July 2, 2029
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
- July 2, 2029
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
- July 2, 2029
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND FORM I LUMACAFTOR
- July 2, 2029
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent 8846718*PED
Issued: September 30, 2014
Inventor(s): Keshavarz-Shokri; Ali et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- January 2, 2030
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  Pediatric exclusivity
Modulators of ATP-binding cassette transporters
Patent 8,993,600
Issued: March 31, 2015
Inventor(s): Hadida Ruah Sara S. & Hamilton Matthew & Miller Mark & Grootenhuis Peter D. J. & Bear Brian & McCartney Jason & Zhou Jinglan
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:
- December 11, 2030
  ✓
  Drug product
Modulators of ATP-binding cassette transporters
Patent 8993600*PED
Issued: March 31, 2015
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:
- June 11, 2031
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  Pediatric exclusivity
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent 9,150,552
Issued: October 6, 2015
Inventor(s): Keshavarz-Shokri Ali & Zhang Beili & Krawiec Mariusz
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- December 4, 2028
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
- December 4, 2028
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  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR FORM I AND IVACAFTOR
- December 4, 2028
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING IVACAFTOR AND FORM I LUMACAFTOR
Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Patent 9150552*PED
Issued: October 6, 2015
Inventor(s): Keshavarz-Shokri; Ali et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Patent expiration dates:
- June 4, 2029
  ✓
  Pediatric exclusivity
Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent 9,192,606
Issued: November 24, 2015
Inventor(s): Young Christopher
Assignee(s): Vertex Pharmaceuticals Incorporated
The present invention relates to formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith.
Patent expiration dates:
- September 29, 2029
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
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  Drug product
- September 29, 2029
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
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  Drug product
- September 29, 2029
  ✓
  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING A DOSAGE UNIT AS DEFINED IN CLAIM 1 OF U.S. PATENT NO. 9,192,606
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  Drug product
Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Patent 9192606*PED
Issued: November 24, 2015
Inventor(s): Young; Christopher
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
The present invention relates to formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith.
Patent expiration dates:
- March 29, 2030
  ✓
  Pediatric exclusivity
Modulators of ATP-binding cassette transporters
Patent 9,216,969
Issued: December 22, 2015
Inventor(s): Ruah Sara S. Hadida & Hamilton Matthew & Miller Mark & Grootenhuis Peter D. J. & Bear Brian & McCartney Jason & Zhou Jinglan
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 (“CFTC”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- November 8, 2026
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  Drug product
- November 8, 2026
  ✓
  Drug substance
  ✓
  Drug product
Modulators of ATP-binding cassette transporters
Patent 9216969*PED
Issued: December 22, 2015
Inventor(s): Ruah; Sara S. Hadida 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 (“CFTC”). The present invention also relates to methods of treating ABC transporter mediated diseases using compounds of the present invention.
Patent expiration dates:
- May 8, 2027
  ✓
  Pediatric exclusivity
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
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
  ✓
  Drug product
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
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  Drug product
- December 28, 2026
  ✓
  Patent use: METHOD OF TREATING A PATIENT HAVING CYSTIC FIBROSIS USING IVACAFTOR AND LUMACAFTOR
  ✓
  Drug product
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 9670163*PED
Issued: June 6, 2017
Inventor(s): Hurter; Patricia et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
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:
- June 28, 2027
  ✓
  Pediatric exclusivity
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 CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
  ✓
  Drug product
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
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  Drug product
- December 28, 2026
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  Patent use: METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT AGE 6 OR OLDER HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING LUMACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (LESS THAN ABOUT 30% CRYSTALLINE) IVACAFTOR
  ✓
  Drug product
Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Patent 9931334*PED
Issued: April 3, 2018
Inventor(s): Hurter; Patricia et al.
Assignee(s): Vertex Pharmaceuticals Incorporated (Boston, MA)
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:
- June 28, 2027
  ✓
  Pediatric exclusivity

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:
- August 7, 2025 - FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 THROUGH 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
- September 2, 2025 - NEW STRENGTH
- September 2, 2025 - NEW PATIENT POPULATION
- December 13, 2027 - ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
- June 13, 2028 - PEDIATRIC EXCLUSIVITY
- September 2, 2029 - TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 1 YEAR TO LESS THAN 2 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
- March 2, 2030 - PEDIATRIC EXCLUSIVITY

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Cystic Fibrosis

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.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill 1V125 is Orkambi ivacaftor 125 mg / lumacaftor 100 mg — Orkambi ivacaftor 125 mg / lumacaftor 100 mg (1V125)