Pharsight

1. List of Kalydeco drug patents

Application	Filing Date	Opposition Party	Legal Status
EP17204189A	2021-09-09	STADA Arzneimittel AG	Granted and Under Opposition
EP17204189A	2021-09-07	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition
EP17204189A	2021-09-06	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP10708442A	2019-10-07	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP06848237A	2017-11-03	Georg Kalhammer/Stephan Teipel	Opposition rejected

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Patent Number	Company	Patent Title	Patent Expiry
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 (3 years from now)
These 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 (2 years from now)
US8354427	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jul, 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)
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)
US11147770	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)
US8883206	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Feb, 2033 (9 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 21, 2027

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

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
150 mg	10 Jun, 2020	1		13 Aug, 2029
25 mg, 50 mg and 75 mg	13 Apr, 2022	1		27 Feb, 2033

Strength	Dosage	Availability
25MG/PACKET	GRANULE;ORAL	Prescription
50MG/PACKET	GRANULE;ORAL	Prescription
75MG/PACKET	GRANULE;ORAL	Prescription

KALYDECO family patents

United States

European Union

Japan

China

Australia

Israel

New Zealand

Hong Kong

Spain

Poland

Canada

Lithuania

Denmark

Croatia

Hungary

Mexico

Portugal

Russia

Slovenia

Cyprus

Korea, Republic of

Brazil

South Africa

Chile

Ukraine

Luxembourg

Netherlands

Norway

Singapore

^new

2. List of Orkambi drug patents

Application	Filing Date	Opposition Party	Legal Status
EP17204189A	2021-09-09	STADA Arzneimittel AG	Granted and Under Opposition
EP17204189A	2021-09-07	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition
EP17204189A	2021-09-06	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP10708442A	2019-10-07	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP06848237A	2017-11-03	Georg Kalhammer/Stephan Teipel	Opposition rejected
EP11715637A	2017-05-18	Alfred E. Tiefenbacher (GmbH & Co. KG)	Patent maintained as amended

^new

Patent Number	Company	Patent Title	Patent Expiry
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 (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 (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).
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)
US9216969	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Nov, 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)
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)
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
New Strength (NS)	Sep 2, 2025
Orphan Drug Exclusivity (ODE)	Aug 7, 2025
New Patient Population (NPP)	Sep 2, 2025

Drugs and Companies using IVACAFTOR; LUMACAFTOR ingredient

Market Authorisation Date: 07 August, 2018

Treatment: 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-methylpyrid...

Dosage: GRANULE;ORAL

Strength	Dosage	Availability
125MG/PACKET;100MG/PACKET	GRANULE;ORAL	Prescription
188MG/PACKET;150MG/PACKET	GRANULE;ORAL	Prescription

ORKAMBI family patents

130

United States

European Union

Japan

China

Spain

New Zealand

Australia

Poland

Denmark

Slovenia

Korea, Republic of

Hungary

Portugal

Canada

Lithuania

Mexico

Israel

Hong Kong

Croatia

Russia

Cyprus

Brazil

South Africa

Norway

Chile

Argentina

Ukraine

Luxembourg

Taiwan

Netherlands

Singapore

San Marino

^new

3. List of Symdeko (copackaged) drug patents

Application	Filing Date	Opposition Party	Legal Status
EP17204189A	2021-09-09	STADA Arzneimittel AG	Granted and Under Opposition
EP17204189A	2021-09-07	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition
EP17204189A	2021-09-06	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP10708442A	2019-10-07	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP15721912A	2019-02-22	Generics (U.K.) Limited	Granted and Under Opposition
EP06848237A	2017-11-03	Georg Kalhammer/Stephan Teipel	Opposition rejected

^new

Patent Number	Company	Patent Title	Patent Expiry
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)
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 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 (2 years from now)
US8354427	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jul, 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)
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)
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)
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 (4 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 (6 years from now)
US10646481	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (6 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)
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)
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 (10 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 (10 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)

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

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

Strength	Dosage	Availability
75MG;75MG, 50MG	TABLET;ORAL	Prescription
150MG;150MG, 100MG	TABLET;ORAL	Prescription

SYMDEKO (COPACKAGED) family patents

100

United States

European Union

Japan

Australia

Spain

China

Hungary

Israel

Poland

New Zealand

Slovenia

Denmark

Portugal

Canada

Lithuania

Mexico

Croatia

Russia

Cyprus

Brazil

Hong Kong

Korea, Republic of

South Africa

Chile

Morocco

Singapore

Ukraine

Norway

Luxembourg

Taiwan

Turkey

Netherlands

India

Argentina

^new

4. List of Trikafta (copackaged) drug patents

Application	Filing Date	Opposition Party	Legal Status
EP17204189A	2021-09-09	STADA Arzneimittel AG	Granted and Under Opposition
EP17204189A	2021-09-07	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition
EP17204189A	2021-09-06	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP15849396A	2021-05-05	Generics [UK] Limited	Granted and Under Opposition
EP10708442A	2019-10-07	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP06848237A	2017-11-03	Georg Kalhammer/Stephan Teipel	Opposition rejected

^new

Patent Number	Company	Patent Title	Patent Expiry
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)
US10239867	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)
US11426407	VERTEX PHARMS INC	NA	Oct, 2035 (12 years from now)
US10758534	VERTEX PHARMS INC	NA	Oct, 2035 (12 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)
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)
These 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 (2 years from now)
US8354427	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jul, 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)
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)
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 (4 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 (6 years from now)
US11564916	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (6 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)
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)
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 (10 years from now)
US11517564	VERTEX PHARMS INC	Methods of treatment for cystic fibrosis	Dec, 2037 (14 years from now)
US11179367	VERTEX PHARMS INC	Pharmaceutical compositions for treating cystic fibrosis	Dec, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
New Patient Population (NPP)	Jun 8, 2024
New Chemical Entity Exclusivity (NCE)	Oct 21, 2024
Orphan Drug Exclusivity (ODE)	Dec 21, 2027

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 12 years and older who have at least one f508del mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatm...

Dosage: TABLET;ORAL