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PREZCOBIX Drug Profile

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Prezcobix is a drug marketed by Janssen Prods and is included in one NDA. It is available from two suppliers. There are nine patents protecting this drug.

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

The generic ingredient in PREZCOBIX is cobicistat; darunavir ethanolate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate profile page.

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYes8,148,374► subscribeYY ► subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesRE43802*PED► subscribe ► subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesRE43596*PED► subscribe ► subscribe
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Expired Patents for Tradename: PREZCOBIX

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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
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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
6,417,387 .alpha.-and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors► subscribe
6,172,082 .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors► subscribe
9,139,541Modulators 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
Hong Kong1126485► subscribe
African Regional IP Organization (ARIPO)2985► subscribe
European Patent Office0810209► 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
C0078France► subscribePRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE COBICISTAT; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2015 00060Denmark► subscribePRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
00283Netherlands► subscribePRODUCT NAME: DARUNAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER DARUNAVIR ETHANOLAAT; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
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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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