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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Baxter
Deloitte
Cerilliant
McKesson
Teva
Chinese Patent Office
Colorcon
Healthtrust

Generated: November 19, 2017

DrugPatentWatch Database Preview

Ivacaftor; lumacaftor - Generic Drug Details

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What are the generic drug sources for ivacaftor; lumacaftor and what is the scope of ivacaftor; lumacaftor freedom to operate?

Ivacaftor; lumacaftor
is the generic ingredient in one branded drug marketed by Vertex Pharms Inc and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; lumacaftor has two hundred and thirty-one patent family members in thirty-two countries and twenty supplementary protection certificates in ten countries.

There are three drug master file entries for ivacaftor; lumacaftor. One supplier is listed for this compound.

Summary for ivacaftor; lumacaftor

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
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-001Jul 2, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-001Jul 2, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-001Jul 2, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► Subscribe ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ivacaftor; lumacaftor

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,324,207Modulators of ATP-binding cassette transporters► Subscribe
7,659,268Modulators of ATP-binding cassette transporters► Subscribe
7,956,052Modulators of ATP-binding cassette transporters► Subscribe
8,802,700Modulators of ATP-Binding Cassette transporters► Subscribe
2,014,187,770► Subscribe
8,354,427Modulators of ATP-binding cassette transporters► Subscribe
9,139,530Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide► Subscribe
8,829,204Modulators of ATP-binding cassette transporters► Subscribe
8,629,162Modulators of ATP-binding cassette transporters► Subscribe
8,741,925Modulators of ATP-binding cassette transporters► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ivacaftor; lumacaftor

Country Document Number Estimated Expiration
Taiwan201034668► Subscribe
China101910156► Subscribe
New Zealand600707► Subscribe
Netherlands300748► Subscribe
European Patent Office3216787► Subscribe
Eurasian Patent Organization201070698► Subscribe
Russian Federation2382779► Subscribe
Mexico2010006179► Subscribe
Cyprus1115750► Subscribe
Serbia56037► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: IVACAFTOR; LUMACAFTOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0748Netherlands► SubscribePRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE (INN: IVACAFTOR) OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
0150028 00162Estonia► SubscribePRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
2015000050Germany► SubscribePRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBONSAEUREAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
2016000035Germany► SubscribePRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOESAEURE, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, ODER EIN ESTER-PRODRUG DAVON.; REGISTRATION NO/DATE: EU/1/15/1059 20151119
9 5006-2016Slovakia► SubscribePRODUCT NAME: LUMAKAFTOR; REGISTRATION NO/DATE: EU/1/15/1059 20151124
2015 00038Denmark► SubscribePRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723
C0045France► SubscribePRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
2016 00019Denmark► SubscribePRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPANCATBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOSYRE, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ELLER ET ESTERPRODRUG DERAF; REG. NO/DATE: EU/1/15/1059 20151124
073Luxembourg► SubscribePRODUCT NAME: ACIDE BENZOIQUE 3-{6-{-1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5-YL)CYCLOPROPANECARBONYL AMINO}-3-METHYLPYRIDIN-2-YL}, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN PRO-MEDICAMENT DE TYPE ESTER DE CELUI-CI; FIRST REGISTRATION DATE: 20151124
761Luxembourg► SubscribePRODUCT NAME: N-(5-HYDROXY-2,4-DIERT-BUTYL-PHENYL)-4OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST REGISTRATION: 20120725
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Accenture
Boehringer Ingelheim
McKinsey
Queensland Health
Fish and Richardson
Dow
Mallinckrodt
Healthtrust
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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