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Serving leading biopharmaceutical companies globally:

Deloitte
QuintilesIMS
Boehringer Ingelheim
McKinsey
Moodys
Daiichi Sankyo
Cantor Fitzgerald
Covington
Chubb
Queensland Health

Generated: November 23, 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 seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ivacaftor has one hundred and thirty-one patent family members in twenty-five countries and twelve supplementary protection certificates in ten countries.

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

Summary for ivacaftor

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► Subscribe► Subscribe
Vertex Pharms Inc
KALYDECO
ivacaftor
GRANULE;ORAL207925-001Mar 17, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► 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► 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
Vertex Pharms
KALYDECO
ivacaftor
TABLET;ORAL203188-001Jan 31, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Vertex Pharms
KALYDECO
ivacaftor
TABLET;ORAL203188-001Jan 31, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-001Jul 2, 2015RXYesYes► 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
2,014,187,770► Subscribe
8,629,162Modulators of ATP-binding cassette transporters► Subscribe
8,741,925Modulators of ATP-binding cassette transporters► Subscribe
9,090,619Modulators of ATP-binding cassette transporters► Subscribe
8,829,204Modulators 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
8,802,700Modulators of ATP-Binding Cassette transporters► Subscribe
8,614,327Modulators of ATP-binding cassette transporters► Subscribe
8,101,767Modulators 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
Serbia53895► Subscribe
Slovenia2502911► Subscribe
Russian Federation2525115► Subscribe
New Zealand587547► Subscribe
Serbia55940► Subscribe
China101935301► Subscribe
CroatiaP20170847► Subscribe
LithuaniaPA2015028► Subscribe
New Zealand552543► Subscribe
Japan2015511583► 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
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
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
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
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
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
2015028Lithuania► SubscribePRODUCT NAME: IVACAFTORUM; REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120723
00748Netherlands► SubscribePRODUCT NAME: N-(5-HYDROXY-2,4-DI-TERT-BUTYL-; 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
Cipla
US Department of Justice
Harvard Business School
Dow
Cantor Fitzgerald
Teva
Argus Health
Accenture
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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