List of Orkambi drug patents

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.

ORKAMBI's oppositions filed in EPO
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

More Information on Dosage

ORKAMBI family patents

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

EA

2

EA

1

San Marino

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