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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
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Cipla
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Generated: August 21, 2017

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PREZCOBIX Drug Profile

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Which patents cover Prezcobix, and what generic Prezcobix alternatives are available?

Prezcobix is a drug marketed by Janssen Prods and is included in one NDA. There are eight patents protecting this drug.

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

The generic ingredient in PREZCOBIX is cobicistat; darunavir ethanolate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate profile page.
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, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: PREZCOBIX

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

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
7,939,553Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,486,942Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,088,770Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,067,449Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,383,655Modulators 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 Tradename: PREZCOBIX

Country Document Number Estimated Expiration
European Patent Office2487161► Subscribe
European Patent Office2049506► Subscribe
Slovenia2049506► Subscribe
Portugal2487165► Subscribe
LithuaniaC2049506► 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: PREZCOBIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
/2016Austria► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE ATAZANAVIR-SULFAT; REGISTRATION NO/DATE: EU/1/15/1025 (MITTEILUNG) 20150715
0780Netherlands► SubscribePRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
/2015Austria► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
/2016Austria► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121
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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Fuji
AstraZeneca
McKinsey
Argus Health
Healthtrust
Moodys
Cipla
Farmers Insurance
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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