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Generated: September 25, 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 one hundred and eighty-eight patent family members in thirty-one countries.

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

Summary for Generic Name: ivacaftor; lumacaftor

Tradenames:1
Patents:15
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Clinical Trials: see list66
Drug Prices:see low prices
DailyMed Link:ivacaftor; lumacaftor at DailyMed
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;ORAL206038-001Jul 2, 2015RXYesYes► Subscribe► SubscribeYY ► 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;ORAL206038-001Jul 2, 2015RXYesYes► Subscribe► Subscribe► 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;ORAL206038-001Jul 2, 2015RXYesYes► Subscribe► SubscribeY ► 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► 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
7,956,052Modulators of ATP-binding cassette transporters► Subscribe
2,014,187,770► Subscribe
8,829,204Modulators of ATP-binding cassette transporters► Subscribe
9,090,619Modulators of ATP-binding cassette transporters► Subscribe
8,802,700Modulators of ATP-Binding Cassette transporters► Subscribe
8,614,327Modulators of ATP-binding cassette transporters► Subscribe
9,434,717Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid► Subscribe
8,354,427Modulators of ATP-binding cassette transporters► Subscribe
8,629,162Modulators of ATP-binding cassette transporters► Subscribe
7,754,739Modulators of CFTR► 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
Canada2627358► Subscribe
Israel180224► Subscribe
Japan2014156468► Subscribe
Slovenia2774925► Subscribe
Spain2624554► Subscribe
Russian Federation2009142030► Subscribe
Japan2008504291► Subscribe
Japan2014139243► Subscribe
Russian Federation2463303► Subscribe
China101935301► 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
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
0150028 00162Estonia► SubscribePRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
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
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
C0020France► SubscribePRODUCT NAME: LUMACAFTOR, SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SES PROMEDICAMENTS ESTERS; REGISTRATION NO/DATE: EU/1/15/1059 20151124
0160015 00195Estonia► SubscribePRODUCT NAME: LUMAKAFTOOR / IVAKAFTOOR;REG NO/DATE: EU/1/15/1059 24.11.2015
0812Netherlands► SubscribePRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPAANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOEZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1059 20151124
15/036Ireland► SubscribePRODUCT NAME: N-(5-HYDROXYL-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120723
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
2015028,C1773816Lithuania► SubscribePRODUCT 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Army
Federal Trade Commission
Merck
Teva
Cerilliant
Baxter
Accenture
Deloitte
Citi
AstraZeneca

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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