Pharsight

1. 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

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 (4 years from now)
US7645789	VERTEX PHARMS INC	Indole derivatives as CFTR modulators	May, 2027 (4 years from now)
US8623905	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (4 years from now)
US7495103	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (4 years from now)
US7776905	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jun, 2027 (4 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 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)
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)
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)
US9974781	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (4 years from now)
US10022352	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (4 years from now)
US8598181	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (4 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)
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

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