Orkambi is owned by Vertex Pharms Inc.
Orkambi contains Ivacaftor; Lumacaftor.
Orkambi has a total of 21 drug patents out of which 0 drug patents have expired.
Orkambi was authorised for market use on 02 July, 2015.
Orkambi is available in tablet;oral dosage forms.
Orkambi can be used as 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, method of treating cystic fibrosis in patients who are homozygous for the f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene; method of treating cystic fibrosis in a patient, the patient having the f508del mutation in cftr, using ivacaftor and form i lumacaftor, 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, 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, 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, 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, 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, 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, method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor, 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, method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor; method of treating cystic fibrosis, 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, 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; method of treating cystic fibrosis in patients who have the f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene..
The generics of Orkambi are possible to be released after 11 December, 2030.
Patent Number | Company | Patent Title | Patent Expiry | Activity Alert |
---|---|---|---|---|
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance. | ||||
US8754224 | VERTEX PHARMS INC | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(3 years from now) | |
US7495103 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
May, 2027
(4 years from now) | |
US10597384 | VERTEX PHARMS INC | Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid |
Dec, 2028
(5 years from now) | |
US8507534 | VERTEX PHARMS INC | Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid |
Sep, 2030
(7 years from now) | |
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
US8741933 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Nov, 2026
(3 years from now) | |
US9216969 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Nov, 2026
(3 years from now) | |
US7973038 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Nov, 2026
(3 years from now) | |
US9931334 | VERTEX PHARMS INC | Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(3 years from now) | |
US9670163 | VERTEX PHARMS INC | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(3 years from now) | |
US8410274 | VERTEX PHARMS INC | Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide |
Dec, 2026
(3 years from now) | |
US8324242 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Aug, 2027
(4 years from now) | |
US9150552 | VERTEX PHARMS INC | Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid |
Dec, 2028
(5 years from now) | |
US8653103 | VERTEX PHARMS INC | Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid |
Dec, 2028
(5 years from now) | |
US10076513 | VERTEX PHARMS INC | 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 |
Dec, 2028
(5 years from now) | |
US11052075 | VERTEX PHARMS INC | 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 |
Dec, 2028
(5 years from now) | |
US8846718 | VERTEX PHARMS INC | Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid |
Jul, 2029
(6 years from now) | |
US11564916 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2029
(6 years from now) | |
US10646481 | VERTEX PHARMS INC | Pharmaceutical composition and administrations thereof |
Aug, 2029
(6 years from now) | |
US9192606 | VERTEX PHARMS INC | Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid |
Sep, 2029
(6 years from now) | |
US8716338 | VERTEX PHARMS INC | Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid |
Sep, 2030
(7 years from now) | |
US8993600 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
Dec, 2030
(7 years from now) |
Exclusivity | Exclusivity Expiration |
---|---|
Orphan Drug Exclusivity (ODE) | Sep 28, 2023 |
Drugs and Companies using IVACAFTOR; LUMACAFTOR ingredient
Market Authorisation Date: 02 July, 2015
Treatment: 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; Method of treating cystic fibrosis using n-(5-hydrox...
Dosage: TABLET;ORAL
130
United States
39
European Union
36
Japan
21
Spain
21
China
17
Australia
17
New Zealand
16
Denmark
16
Poland
15
Slovenia
15
Hungary
15
Portugal
15
Korea, Republic of
14
Lithuania
14
Canada
13
Israel
13
Mexico
12
Hong Kong
12
Russia
12
Croatia
12
Cyprus
12
RS
10
Brazil
7
South Africa
7
ME
4
Norway
3
Argentina
3
Chile
2
Singapore
2
Netherlands
2
Taiwan, Province of China
2
Luxembourg
2
Ukraine
2
EA
1
San Marino
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