Generic Orkambi Availability
Last updated on Jan 11, 2023.
Orkambi is a brand name of ivacaftor/lumacaftor, approved by the FDA in the following formulation(s):
ORKAMBI (ivacaftor; lumacaftor - granule;oral)
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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)
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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]
Has a generic version of Orkambi been approved?
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.
See also: Generic Drug FAQ.
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.
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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 10,076,513
Issued: September 18, 2018
Assignee(s): Vertex Pharmaceuticals IncorporatedA 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✓✓
- December 4, 2028
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Patent 10,597,384
Patent expiration dates:
- December 4, 2028✓✓✓
- December 4, 2028✓✓✓
- December 4, 2028✓✓✓
- December 4, 2028
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Patent 10,646,481
Patent expiration dates:
- August 13, 2029✓
- August 13, 2029
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Patent 11,052,075
Patent expiration dates:
- December 4, 2028✓✓
- December 4, 2028
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Modulators of ATP-binding cassette transporters
Patent 7,495,103
Issued: February 24, 2009
Inventor(s): Hadida-Ruah; Sara & Hazelwood; Anna & Grootenhuis; Peter & Van Goor; Fred & Singh; Ashvani & Zhou; Jinglan & McCartney; Jason
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓✓
- May 20, 2027
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Modulators of ATP-binding cassette transporters
Patent 7,973,038
Issued: July 5, 2011
Inventor(s): Hadida Ruah; Sara S. & Hamilton; Matthew & Miller; Mark T. & Grootenhuis; Peter D. J. & Bear; Brian Richard & McCartney; Jason & Zhou; Jinglan
Assignee(s): Vertex Pharmaceuticals IncorporatedCompounds 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✓
- November 8, 2026✓
- November 8, 2026✓
- November 8, 2026
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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 IncorporatedThe 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✓
- August 5, 2027✓
- August 5, 2027✓
- August 5, 2027✓
- August 5, 2027
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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
Assignee(s): Vertex PharmaceuticalsThe 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✓
- December 28, 2026
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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 8,507,534
Issued: August 13, 2013
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓✓
- September 20, 2030
-
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
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓
- December 4, 2028
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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
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓✓
- September 20, 2030✓✓
- September 20, 2030✓✓
- September 20, 2030✓✓
- September 20, 2030
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Modulators of ATP-binding cassette transporters
Patent 8,741,933
Issued: June 3, 2014
Assignee(s): Vertex Pharmaceuticals IncorporatedCompounds 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✓
- November 8, 2026✓
- November 8, 2026✓
- November 8, 2026✓
- November 8, 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 8,754,224
Issued: June 17, 2014
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓✓
- December 28, 2026
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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
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓
- July 2, 2029✓
- July 2, 2029✓
- July 2, 2029✓
- July 2, 2029
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Modulators of ATP-binding cassette transporters
Patent 8,993,600
Issued: March 31, 2015
Assignee(s): Vertex Pharmaceuticals IncorporatedCompounds 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✓
- December 11, 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 9,150,552
Issued: October 6, 2015
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓
- December 4, 2028✓
- December 4, 2028✓
- December 4, 2028
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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
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓✓
- September 29, 2029✓✓
- September 29, 2029✓✓
- September 29, 2029
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Modulators of ATP-binding cassette transporters
Patent 9,216,969
Issued: December 22, 2015
Assignee(s): Vertex Pharmaceuticals IncorporatedCompounds 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✓
- November 8, 2026✓✓
- November 8, 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 9,670,163
Issued: June 6, 2017
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓✓
- December 28, 2026✓✓
- December 28, 2026✓✓
- 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 9,931,334
Issued: April 3, 2018
Assignee(s): Vertex Pharmaceuticals IncorporatedThe 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✓✓
- December 28, 2026✓✓
- December 28, 2026✓✓
- December 28, 2026
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:
- July 2, 2022 - TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR F508DEL MUTATION IN THE CFTR GENE
- September 28, 2023 - TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6-11 YEAR OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
- 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 PATIENT POPULATION
- September 2, 2025 - NEW STRENGTH
More about Orkambi (ivacaftor / lumacaftor)
- Check interactions
- Pricing & coupons
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: CFTR combinations
- En español
Patient resources
Professional resources
Related treatment guides
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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.