Pharsight

Vertex Pharms Inc patents expiration

1. Kalydeco patents expiration

KALYDECO'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.
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

(3 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).
US8629162 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jun, 2025

(1 year, 8 months from now)

US8354427 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jul, 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

(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

(3 years from now)

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

(5 years from now)

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

(5 years from now)

US8883206 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(9 years from now)

US10272046 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(9 years from now)

US11147770 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(9 years from now)

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE) May 3, 2030
New Patient Population (NPP) May 3, 2026

Drugs and Companies using IVACAFTOR ingredient

Market Authorisation Date: 17 March, 2015

Treatment: Treatment of a moderate mild clinical phenotype of cf using ivacaftor in a patient age 6 months to <6 years who has one cftr mutation repsonsive to ivacaftor based on clinical and/or in vitro assay da...

Dosage: GRANULE;ORAL

How can I launch a generic of KALYDECO before it's drug patent expiration?
More Information on Dosage

KALYDECO family patents

Family Patents

2. 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.
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

(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

(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

(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

(3 years from now)

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

(3 years from now)

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

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)

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

(3 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)

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)

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)

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)

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

(5 years from now)

US11564916 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

(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

(6 years from now)

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

(7 years from now)

Drug Exclusivity Drug 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 in a patient, the...

Dosage: TABLET;ORAL

More Information on Dosage

ORKAMBI family patents

Family Patents

3. Symdeko (copackaged) patents expiration

SYMDEKO (COPACKAGED)'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.
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)

US11639347 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Apr, 2027

(3 years from now)

US10239867 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Apr, 2027

(3 years from now)

US7645789 VERTEX PHARMS INC Indole derivatives as CFTR modulators
May, 2027

(3 years from now)

US8623905 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
May, 2027

(3 years from now)

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

(3 years from now)

US7776905 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jun, 2027

(3 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).
US8629162 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jun, 2025

(1 year, 8 months from now)

US8354427 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jul, 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

(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)

US9974781 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Apr, 2027

(3 years from now)

US10022352 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Apr, 2027

(3 years from now)

US8598181 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
May, 2027

(3 years from now)

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

(3 years from now)

US8415387 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Nov, 2027

(4 years from now)

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

(5 years from now)

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

(5 years from now)

US10081621 VERTEX PHARMS INC Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide
Mar, 2031

(7 years from now)

US11578062 VERTEX PHARMS INC Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide
Mar, 2031

(7 years from now)

US9012496 VERTEX PHARMS INC Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof
Jul, 2033

(9 years from now)

US10058546 VERTEX PHARMS INC Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof
Jul, 2033

(9 years from now)

US10206877 VERTEX PHARMS INC Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Apr, 2035

(11 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE) Feb 12, 2023
Orphan Drug Exclusivity (ODE) Dec 21, 2027

Drugs and Companies using IVACAFTOR; IVACAFTOR, TEZACAFTOR ingredient

NCE-1 date: 2022-02-12

Market Authorisation Date: 12 February, 2018

Treatment: Tezacaftor and ivacaftor for the treatment of patients with a mild to moderate clinical phenotype of cystic fibrosis having at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor b...

Dosage: TABLET;ORAL

More Information on Dosage

SYMDEKO (COPACKAGED) family patents

Family Patents

4. Trikafta (copackaged) patents expiration

TRIKAFTA (COPACKAGED)'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.
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)

US10239867 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Apr, 2027

(3 years from now)

US11639347 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Apr, 2027

(3 years from now)

US8623905 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
May, 2027

(3 years from now)

US7645789 VERTEX PHARMS INC Indole derivatives as CFTR modulators
May, 2027

(3 years from now)

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

(3 years from now)

US7776905 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jun, 2027

(3 years from now)

US10758534 VERTEX PHARMS INC NA
Oct, 2035

(12 years from now)

US11426407 VERTEX PHARMS INC NA
Oct, 2035

(12 years from now)

US10793547 VERTEX PHARMS INC Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Dec, 2037

(14 years from now)

US11453655 VERTEX PHARMS INC Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Dec, 2037

(14 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).
US8629162 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jun, 2025

(1 year, 8 months from now)

US8354427 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Jul, 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

(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)

US10022352 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Apr, 2027

(3 years from now)

US9974781 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Apr, 2027

(3 years from now)

US8598181 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
May, 2027

(3 years from now)

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

(3 years from now)

US8415387 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
Nov, 2027

(4 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)

US10081621 VERTEX PHARMS INC Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide
Mar, 2031

(7 years from now)

US11578062 VERTEX PHARMS INC Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide
Mar, 2031

(7 years from now)

US10272046 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(9 years from now)

US11147770 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(9 years from now)

US8883206 VERTEX PHARMS INC Pharmaceutical composition and administrations thereof
Feb, 2033

(9 years from now)

US9012496 VERTEX PHARMS INC Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof
Jul, 2033

(9 years from now)

US11179367 VERTEX PHARMS INC Pharmaceutical compositions for treating cystic fibrosis
Dec, 2037

(14 years from now)

US11517564 VERTEX PHARMS INC Methods of treatment for cystic fibrosis
Dec, 2037

(14 years from now)

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity (NCE) Oct 21, 2024
Orphan Drug Exclusivity (ODE) Jun 8, 2028
New Patient Population (NPP) Jun 8, 2024

Drugs and Companies using ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR ingredient

NCE-1 date: 2023-10-22

Market Authorisation Date: 21 October, 2019

Treatment: Treatment of a moderate to mild clinical phenotype of cf in patients aged 2 to <6 years who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based ...

Dosage: TABLET;ORAL

More Information on Dosage

TRIKAFTA (COPACKAGED) family patents

Family Patents

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