List of Trikafta (copackaged) drug patents

Trikafta (Copackaged) is owned by Vertex Pharms Inc.

Trikafta (Copackaged) contains Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor.

Trikafta (Copackaged) has a total of 25 drug patents out of which 0 drug patents have expired.

Trikafta (Copackaged) was authorised for market use on 21 October, 2019.

Trikafta (Copackaged) is available in tablet;oral dosage forms.

Trikafta (Copackaged) can be used as treatment of cystic fibrosis in patients aged 12 years and older who have one f508del mutation and one r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 12 years and older who have a r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 6 years and older who have a r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor, treatment of cf in patients aged 12 years and older who have at least one f508del mutation in the cftr gene using a solid composition comprising elexacaftor, tezacaftor, amorphous ivacaftor, and less than about 30% crystalline ivacaftor; treatment of cf in patients 12 years and older who have at least one f508del mutation or a mutation in the cftr gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva; treatment of cf in patients 6 years and older who have at least one f508del mutation or a mutation in the cftr gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva, treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with an effective amount of elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva; treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva, treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with an effective amount of a pharmaceutical composition comprising elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene with an effective amount of a pharmaceutical composition comprising elexacaftor, tezacaftor, and ivacaftor, treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor, treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data by administering daily elx (200 mg or 100 mg); tez; and iva, treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with a composition comprising elexacaftor, tezacaftor, and ivacaftor; and another composition comprising ivacaftor; treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene with a composition comprising elexacaftor, tezacaftor, and ivacaftor; and another composition comprising ivacaftor, 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; 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 or a mutation in the cftr gene that is responsive based on in vitro data with elx, tez, and iva; treatment of a moderate to mild clinical phenotype of cf in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elx, tez, and iva, treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with a composition according to claim 1 of us 10081621; treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with a composition according to claim 1 of us 10081621; treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with a composition according to claim 1 of us 10081621, treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor, treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data with a composition according to at least one of claims 1-9 of us11179367, treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor; treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor, treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data with a compound of claim 1 or composition of claim 29 of us11426407.

Drug patent challenges can be filed against Trikafta (Copackaged) from October, 2023.

The generics of Trikafta (Copackaged) are possible to be released after 08 December, 2037.

Patent Number Company Patent Title Patent Expiry Activity Alert
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
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(4 years from now)

US8623905 VERTEX PHARMS INC Modulators of ATP-binding cassette transporters
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US7645789 VERTEX PHARMS INC Indole derivatives as CFTR modulators
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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)

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)

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

(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
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(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)

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

(8 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)

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)

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: October, 2023

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; 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 or a mutation in the cftr gene that is responsive based on in vitro data with elx, tez, and iva; Treatment of a moderate to mild clinical phenotype of cf in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elx, tez, and iva; Treatment of cystic fibrosis in patients aged 12 years and older who have one f508del mutation and one r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older who have a r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have a r117h mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of cf in patients aged 12 years and older who have at least one f508del mutation in the cftr gene using a solid composition comprising elexacaftor, tezacaftor, amorphous ivacaftor, and less than about 30% crystalline ivacaftor; Treatment of cf in patients 12 years and older who have at least one f508del mutation or a mutation in the cftr gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva; Treatment of cf in patients 6 years and older who have at least one f508del mutation or a mutation in the cftr gene that is responsive based on in vitro data using a solid composition comprising elx, tez, amorphous iva, and < ~30% crystalline iva; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with an effective amount of a pharmaceutical composition comprising elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene with an effective amount of a pharmaceutical composition comprising elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with a composition according to claim 1 of us 10081621; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with a composition according to claim 1 of us 10081621; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with a composition according to claim 1 of us 10081621; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with a composition comprising elexacaftor, tezacaftor, and ivacaftor; And another composition comprising ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene with a composition comprising elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data with a composition according to at least one of claims 1-9 of us11179367; Treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data by administering daily elx (200 mg or 100 mg); Tez; And iva; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene with an effective amount of elexacaftor, tezacaftor, and ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva; Treatment of cystic fibrosis in patients aged 12 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive based on in vitro data with an effective amount of elx, tez, and iva; Treatment of cystic fibrosis in patients aged 6 years and older who have in the cftr gene at least one f508del mutation or a mutation that is responsive based on in vitro data with a compound of claim 1 or composition of claim 29 of us11426407

Dosage: TABLET;ORAL

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