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Last Updated: April 21, 2024

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SYMDEKO (COPACKAGED) Drug Patent Profile


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Which patents cover Symdeko (copackaged), and what generic alternatives are available?

Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty-four patents protecting this drug.

This drug has four hundred and sixteen patent family members in thirty-nine countries.

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

DrugPatentWatch® Generic Entry Outlook for Symdeko (copackaged)

Symdeko (copackaged) was eligible for patent challenges on February 12, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SYMDEKO (COPACKAGED)
International Patents:416
US Patents:24
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:SYMDEKO (COPACKAGED) at DailyMed
Drug patent expirations by year for SYMDEKO (COPACKAGED)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SYMDEKO (COPACKAGED)
Generic Entry Date for SYMDEKO (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for SYMDEKO (COPACKAGED)

SYMDEKO (COPACKAGED) is protected by thirty-seven US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYMDEKO (COPACKAGED) is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SYMDEKO (COPACKAGED)

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

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)cyclopropanecarboxa- mide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

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)cyclopropanecarboxa- mide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

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)cyclopropanecarboxa- mide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

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)cyclopropanecarboxa- mide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Pharmaceutical composition and administrations thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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 11578062 CLAIM 6 OR 13


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Indole derivatives as CFTR modulators
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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)cyclopropanecarbox- amide and administration thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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 (

Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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 (

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

Modulators of ATP-binding cassette transporters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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

FDA Regulatory Exclusivity protecting SYMDEKO (COPACKAGED)

TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AGED 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR
Exclusivity Expiration: ⤷  Try a Trial

FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-001 Feb 12, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Vertex Pharms Inc SYMDEKO (COPACKAGED) ivacaftor; ivacaftor, tezacaftor TABLET;ORAL 210491-002 Jun 21, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for SYMDEKO (COPACKAGED)

When does loss-of-exclusivity occur for SYMDEKO (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15247850
Estimated Expiration: ⤷  Try a Trial

Patent: 19250116
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2016023422
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 44140
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 16002600
Estimated Expiration: ⤷  Try a Trial

Patent: 20002757
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6163517
Estimated Expiration: ⤷  Try a Trial

Patent: 0840847
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0181194
Estimated Expiration: ⤷  Try a Trial

Patent: 0211012
Estimated Expiration: ⤷  Try a Trial

Patent: 0230709
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20582
Estimated Expiration: ⤷  Try a Trial

Patent: 24568
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 31582
Estimated Expiration: ⤷  Try a Trial

Patent: 24534
Estimated Expiration: ⤷  Try a Trial

Patent: 25607
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 31582
Estimated Expiration: ⤷  Try a Trial

Patent: 24534
Estimated Expiration: ⤷  Try a Trial

Patent: 25607
Estimated Expiration: ⤷  Try a Trial

Patent: 23294
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 25607
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 39062
Estimated Expiration: ⤷  Try a Trial

Patent: 55369
Estimated Expiration: ⤷  Try a Trial

Patent: 62736
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8359
Estimated Expiration: ⤷  Try a Trial

Patent: 6286
Estimated Expiration: ⤷  Try a Trial

Patent: 3422
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 43268
Estimated Expiration: ⤷  Try a Trial

Patent: 17511344
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 31582
Estimated Expiration: ⤷  Try a Trial

Patent: 24534
Estimated Expiration: ⤷  Try a Trial

Patent: 25607
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 16013301
Estimated Expiration: ⤷  Try a Trial

Patent: 21013638
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 004
Estimated Expiration: ⤷  Try a Trial

Patent: 476
Estimated Expiration: ⤷  Try a Trial

Patent: 774
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4488
Estimated Expiration: ⤷  Try a Trial

Patent: 3453
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 31582
Estimated Expiration: ⤷  Try a Trial

Patent: 24534
Estimated Expiration: ⤷  Try a Trial

Patent: 25607
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 31582
Estimated Expiration: ⤷  Try a Trial

Patent: 24534
Estimated Expiration: ⤷  Try a Trial

Patent: 25607
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 44460
Estimated Expiration: ⤷  Try a Trial

Patent: 16144479
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 476
Estimated Expiration: ⤷  Try a Trial

Patent: 140
Estimated Expiration: ⤷  Try a Trial

Patent: 400
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201913575V
Estimated Expiration: ⤷  Try a Trial

Patent: 201607670X
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 31582
Estimated Expiration: ⤷  Try a Trial

Patent: 24534
Estimated Expiration: ⤷  Try a Trial

Patent: 25607
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1606418
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2447581
Estimated Expiration: ⤷  Try a Trial

Patent: 160145124
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 75858
Estimated Expiration: ⤷  Try a Trial

Patent: 85181
Estimated Expiration: ⤷  Try a Trial

Patent: 57761
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1809684
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 4567
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SYMDEKO (COPACKAGED) around the world.

Country Patent Number Title Estimated Expiration
Japan 5734369 ⤷  Try a Trial
China 104788328 Modulators of ATP-binding cassette transporters ⤷  Try a Trial
Portugal 3219705 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYMDEKO (COPACKAGED)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2826776 CR 2021 00013 Denmark ⤷  Try a Trial PRODUCT NAME: EN KOMBINATION AF (A) (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)CYCLOPROPANECARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) ....; REG. NO/DATE: EU/1/18/1306 20181106
2826776 2021C/517 Belgium ⤷  Try a Trial PRODUCT NAME: SYMKEVI - TEZACAFTOR/IVACAFTOR; EEN COMBINATIE VAN (A) (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 OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OF EEN VANUIT FARMACEUTISCH OOGPUNT GESCHIKT ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106
1773816 PA2015028,C1773816 Lithuania ⤷  Try a Trial PRODUCT NAME: IVAKAFTORAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002, 0120723
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