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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson
Cantor Fitzgerald
Dow
Cipla
Boehringer Ingelheim
Novartis
Queensland Health
Medtronic
Mallinckrodt

Generated: July 24, 2017

DrugPatentWatch Database Preview

Ivacaftor - Generic Drug Details

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What are the generic sources for ivacaftor and what is the scope of ivacaftor patent protection?

Ivacaftor
is the generic ingredient in two branded drugs marketed by Vertex Pharms Inc and Vertex Pharms, and is included in three NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor has one hundred and five patent family members in twenty-two countries.

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

Summary for Generic Name: ivacaftor

Tradenames:2
Patents:18
Applicants:2
NDAs:3
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Bulk Api Vendors: see list58
Clinical Trials: see list65
Patent Applications: see list228
Drug Prices:see low prices
DailyMed Link:ivacaftor 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► 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► SubscribeY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-001Jul 2, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Vertex Pharms Inc
KALYDECO
ivacaftor
GRANULE;ORAL207925-001Mar 17, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ivacaftor

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
8,741,925Modulators 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
8,101,767Modulators of ATP-binding cassette transporters► Subscribe
9,090,619Modulators of ATP-binding cassette transporters► Subscribe
8,629,162Modulators 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

Country Document Number Estimated Expiration
Russian Federation2525115► Subscribe
Israel213155► Subscribe
Japan2015096539► Subscribe
Mexico2014010253► Subscribe
CroatiaP20150277► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0045France► SubscribePRODUCT NAME: IVACAFTOR, OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
00748Netherlands► SubscribePRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; REGISTRATION NO/DATE: EU/1/12/782/001-002 20120725
2015028Lithuania► SubscribePRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
McKinsey
Citi
Federal Trade Commission
Novartis
Mallinckrodt
Medtronic
Fish and Richardson
Boehringer Ingelheim

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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