Pharsight

1. Kalydeco patents expiration

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

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
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

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

2. Orkambi patents expiration

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

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
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

Strength	Dosage	Availability
125MG;100MG	TABLET;ORAL	Prescription
125MG;200MG	TABLET;ORAL	Prescription

ORKAMBI family patents

3. Symdeko (copackaged) patents expiration

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

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
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

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

SYMDEKO (COPACKAGED) family patents

4. Trikafta (copackaged) patents expiration

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

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
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