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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
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McKesson
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US Department of Justice
Queensland Health
US Army
Argus Health
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Generated: August 19, 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 fifteen patents protecting this drug.

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

The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three 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, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-001Jul 2, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Vertex Pharms Inc
ORKAMBI
ivacaftor; lumacaftor
TABLET;ORAL206038-001Jul 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;ORAL206038-002Sep 28, 2016RXYesNo► Subscribe► 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
8,741,925Modulators 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
8,318,733Modulators of ATP-binding cassette transporters► Subscribe
2,014,187,770► Subscribe
8,012,999Modulators 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 Tradename: ORKAMBI

Country Document Number Estimated Expiration
Mexico2011003249► Subscribe
Spain2611077► Subscribe
South Korea20100101130► Subscribe
BrazilPI0821039► Subscribe
Hong Kong1125366► 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
7 5014-2015Slovakia► SubscribePRODUCT NAME: N-(5-HYDROXY-2,4-DITERC-BUTYL-FENYL)-4-OXO- -1H-CHINOLIN-3-KARBOXAMID (IVACAFTOR); REGISTRATION NO/DATE: EU/1/12/782/001 - EU/1/12/782/002 20120725
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
2016015Lithuania► SubscribePRODUCT NAME: LUMAKAFTORAS/IVAKAFTORAS; REGISTRATION NO/DATE: EU/1/15/1059 20151119
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
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
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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Cantor Fitzgerald
US Army
Citi
McKinsey
Chubb
Mallinckrodt
Farmers Insurance
AstraZeneca
Deloitte

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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