Pharsight

Orkambi patents expiration

ORKAMBI's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9216969 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Nov, 2026

(2 years from now)

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

(2 years from now)

US7495103 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
May, 2027

(3 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

(4 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

(6 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9216969 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Nov, 2026

(2 years from now)

US7973038 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Nov, 2026

(2 years from now)

US8741933 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Nov, 2026

(2 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

(2 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

(2 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

(2 years from now)

US8324242 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Aug, 2027

(3 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

(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

(4 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

(4 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

(4 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

(5 years from now)

US11564916 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Aug, 2029

(5 years from now)

US10646481 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Aug, 2029

(5 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

(5 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

(6 years from now)

US8993600 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Dec, 2030

(6 years from now)

Orkambi is owned by Vertex Pharms Inc.

Orkambi contains Ivacaftor; Lumacaftor.

Orkambi has a total of 22 drug patents out of which 0 drug patents have expired.

Orkambi was authorised for market use on 02 September, 2022.

Orkambi is available in tablet;oral, granule;oral dosage forms.

Orkambi can be used as method of treating cystic fibrosis in patients who are homozygous for the f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene, 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, 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, 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 ivacaftor and form i lumacaftor, 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, 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 as recited in claim 1 of us patent 8716338 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 lumacaftor and ivacaftor, 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, 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.

Drug patent challenges can be filed against Orkambi from 03 July, 2019.

The generics of Orkambi are possible to be released after 11 December, 2030.

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-195) Aug 07, 2025
New Patient Population(NPP) Sep 02, 2025
Orphan Drug Exclusivity(ODE-408) Sep 02, 2029
New Strength(NS) Sep 02, 2025
New Chemical Entity Exclusivity(NCE) Jul 02, 2020
New Product(NP) Aug 07, 2021

Drugs and Companies using IVACAFTOR; LUMACAFTOR ingredient

NCE-1 date: 03 July, 2019

Market Authorisation Date: 02 September, 2022

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 in patients who a...

Dosage: GRANULE;ORAL; TABLET;ORAL

More Information on Dosage

ORKAMBI family patents

Family Patents