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Serving 500+ biopharmaceutical companies globally:

Julphar
AstraZeneca
Covington
Healthtrust
Chubb
Argus Health
Mallinckrodt
Harvard Business School
Boehringer Ingelheim
US Department of Justice

Generated: June 28, 2017

DrugPatentWatch Database Preview

ORKAMBI Drug Profile

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What is the patent landscape for Orkambi, and what generic Orkambi alternatives are available?

Orkambi is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and eighty patent family members in thirty-one countries.

The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; lumacaftor profile page.
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;ORAL206038-001Jul 2, 2015RXYesYes8,716,338► SubscribeY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo7,495,103► SubscribeYY ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-001Jul 2, 2015RXYesYes8,754,224► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Tradename: ORKAMBI

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
8,012,999Modulators of CFTR► Subscribe
8,318,733Modulators of ATP-binding cassette transporters► Subscribe
8,614,327Modulators of ATP-binding cassette transporters► Subscribe
7,741,321Modulators 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 Tradename: ORKAMBI

Country Document Number Estimated Expiration
Japan5762940► Subscribe
Japan2013253111► Subscribe
Japan2017014290► Subscribe
European Patent Office2489659► Subscribe
Portugal1773816► 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: ORKAMBI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2016015Lithuania► SubscribePRODUCT NAME: LUMAKAFTORAS/IVAKAFTORAS; REGISTRATION NO/DATE: EU/1/15/1059 20151119
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
0150028 00162Estonia► SubscribePRODUCT NAME: IVAKAFTOOR;REG NO/DATE: EU/1/12/782/001-002 25.07.2012
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
Mallinckrodt
Medtronic
US Army
Cerilliant
Colorcon
Harvard Business School
McKesson
Merck
Novartis

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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