Symdeko (Copackaged) is owned by Vertex Pharms Inc.
Symdeko (Copackaged) contains Ivacaftor; Ivacaftor, Tezacaftor.
Symdeko (Copackaged) has a total of 22 drug patents out of which 0 drug patents have expired.
Symdeko (Copackaged) was authorised for market use on 12 February, 2018.
Symdeko (Copackaged) is available in tablet;oral dosage forms.
Symdeko (Copackaged) can be used as treating cystic fibrosis patients ages 6 and older, who are homozygous for f508del or have at least 1 cftr gene mutation responsive to tezacaftor/ivacaftor, with tezacaftor and a solid composition comprising amorphous (<30% crystalline) ivacaftor; treating cystic fibrosis patients ages 12 and older, who are homozygous for f508del or have at least 1 cftr gene mutation responsive to tezacaftor/ivacaftor, with tezacaftor and a solid composition comprising amorphous (<30% crystalline) ivacaftor, tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the f508del mutation or heterozygous for the f508del mutation and a second mutation that is responsive to tezacaftor/ivacaftor, treatment of cystic fibrosis in patients aged 12 and older, who are homozygous for the f508del mutation or have at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; treatment of cystic fibrosis in patients aged 6 and older, who are homozygous for the f508del mutation or have at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor, tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the f508del mutation or having at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence, 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 based on in vitro data and/or clinical evidence, treatment of cystic fibrosis in patients ages 12 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; treatment of cystic fibrosis in patients ages 6 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; treatment of cystic fibrosis in patients age 6 and older, who have two copies of the f508del mutation or at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; treatment of cystic fibrosis in patients age 12 and older, who have two copies of the f508del mutation or at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877, treatment of cf in a patient age 6 years and older who is homozygous for f508del or has at least one cftr gene mutation responsive to tez/iva based on in vitro data and/or clinical evidence using the composition recited in us 11564916 claim 1, treatment of cystic fibrosis in patients 12 years and older, with a f508del or g551d cftr gene mutation and a a455e, 2789+5g->a, or 3849+10kbc->t mutation, comprising concurrent coadministration of the compositions of claim 1 of u.s patent 10058546; treatment of cystic fibrosis in patients 6 years and older, with a f508del or g551d cftr gene mutation and a a455e, 2789+5g->, or 3849+10kbc->t mutation, comprising concurrent coadministration of the compositions of claim 1 of u.s. patent 10058546; treatment of cf in patients 6 years and older who have a f508del or g551d cftr mutation and a 2nd mutation selected from r117h, a455e, 2789+5g->a, and 3849+10kbc->t, comprising concurrent coadministration of the compositions of claim 1 of us 10058546; treatment of cf in patients 12 years and older who have a f508del or g551d cftr mutation and a 2nd mutation selected from r117h, a455e, 2789+5g->a, & 3849+10kbc->t, comprising concurrent coadministration of the compositions of claim 1 of us 10058546, treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the f508del mutation or have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor; treatment of cystic fibrosis in patients aged 12 years and older, who are homozygous for the f508del mutation or have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor, treatment of cystic fibrosis in patients age 12 and older, who have two copies of the f508del mutation or who have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; treatment of cystic fibrosis in patients ages 6 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; treatment of cystic fibrosis in patients age 6 and older, who have two copies of the f508del mutation or who have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; treatment of cystic fibrosis in patients ages 12 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621, treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the f508del mutation or heterozygous for f508del and a second cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; treatment of cystic fibrosis in patients aged 12 years and older, who are homozygous for the f508del mutation or heterozygous for f508del and a second cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor, tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients age 6 years and older who have a r117h mutation in the cftr gene.
Drug patent challenges can be filed against Symdeko (Copackaged) from 2022-02-12.
The generics of Symdeko (Copackaged) are possible to be released after 14 April, 2035.
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 |
Apr, 2027
(4 years from now) | |
US8623905 | VERTEX PHARMS INC | Modulators of ATP-binding cassette transporters |
May, 2027
(4 years from now) | |
US7645789 | VERTEX PHARMS INC | Indole derivatives as CFTR modulators |
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) | |
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
(4 years from now) | |
US9974781 | 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) | |
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) | |
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) | |
US10206877 | VERTEX PHARMS INC | Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases |
Apr, 2035
(12 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
100
United States
36
European Union
24
Japan
19
Australia
18
Spain
17
China
16
Israel
16
Hungary
15
Poland
15
New Zealand
14
Denmark
14
Slovenia
14
Portugal
13
Lithuania
13
Canada
12
Mexico
11
Croatia
11
RS
10
Russia
10
Cyprus
8
Hong Kong
8
Brazil
6
Korea, Republic of
6
ME
5
South Africa
3
Morocco
3
Singapore
3
Chile
2
Norway
2
Ukraine
1
Turkey
1
Argentina
1
Netherlands
1
India
1
Luxembourg
1
Taiwan, Province of China
1
EA
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