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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
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Harvard Business School
Colorcon
Cantor Fitzgerald
Covington
Baxter
Queensland Health
US Department of Justice
Express Scripts

Generated: June 29, 2017

DrugPatentWatch Database Preview

Cobicistat; darunavir ethanolate - Generic Drug Details

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What are the generic sources for cobicistat; darunavir ethanolate and what is the scope of cobicistat; darunavir ethanolate patent protection?

Cobicistat; darunavir ethanolate
is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir ethanolate has one hundred and twenty-three patent family members in thirty-one countries.

There are five drug master file entries for cobicistat; darunavir ethanolate. One supplier is listed for this compound.

Summary for Generic Name: cobicistat; darunavir ethanolate

Tradenames:1
Patents:9
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packagers: see list1
Clinical Trials: see list208
Drug Prices:see low prices
DailyMed Link:cobicistat; darunavir ethanolate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes8,518,987*PED► SubscribeY► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYesRE43802*PED► Subscribe ► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes7,700,645*PED► SubscribeY► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYesRE42889*PED► Subscribe ► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: cobicistat; darunavir ethanolate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 20155,843,946*PED► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RE43802*PED► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RE42889*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cobicistat; darunavir ethanolate

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
8,383,655Modulators of pharmacokinetic properties of therapeutics► Subscribe
9,139,541Modulators of pharmacokinetic properties of therapeutics► Subscribe
7,939,553Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,088,770Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,486,942Modulators of pharmacokinetic properties of therapeutics► 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: cobicistat; darunavir ethanolate

Country Document Number Estimated Expiration
European Patent Office2170851► Subscribe
BrazilPI0807581► Subscribe
African Regional IP Organization (ARIPO)3915► Subscribe
African Regional IP Organization (ARIPO)200904964► Subscribe
Japan2014088441► 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: COBICISTAT; DARUNAVIR ETHANOLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016038Lithuania► SubscribePRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2015040Lithuania► SubscribePRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2016040Lithuania► SubscribePRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
864Luxembourg► SubscribePRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20130527
0860Netherlands► SubscribePRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
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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
Citi
McKinsey
Express Scripts
Accenture
Fuji
Merck
Healthtrust
Moodys
Chinese Patent Office

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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