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Serving 500+ biopharmaceutical companies globally:

UBS
Fuji
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US Army
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Federal Trade Commission
Mallinckrodt
Chubb
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Generated: July 21, 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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor; lumacaftor has one hundred and eighty 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:16
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Clinical Trials: see list62
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, 2015RXYesYes8,846,718► Subscribe ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo8,410,274► SubscribeY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo8,716,338► SubscribeY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo9,192,606► 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
7,741,321Modulators of ATP-binding cassette transporters► Subscribe
8,629,162Modulators of ATP-binding cassette transporters► Subscribe
8,741,925Modulators of ATP-binding cassette transporters► Subscribe
8,324,207Modulators 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
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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
South Korea101561482► Subscribe
Canada2635581► Subscribe
Australia2009296271► Subscribe
Japan2012504143► Subscribe
South Korea20130042034► 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
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
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
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
2016015Lithuania► SubscribePRODUCT NAME: LUMAKAFTORAS/IVAKAFTORAS; REGISTRATION NO/DATE: EU/1/15/1059 20151119
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Moodys
Fish and Richardson
Johnson and Johnson
McKinsey
Chinese Patent Office
Colorcon
Argus Health
US Department of Justice
US Army

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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