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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
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QuintilesIMS
Daiichi Sankyo
AstraZeneca
Chubb
US Department of Justice
US Army
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Generated: September 20, 2018

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PREZCOBIX Drug Profile

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When do Prezcobix patents expire, and when can generic versions of Prezcobix launch?

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

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.

Drug patent expirations by year for PREZCOBIX
Generic Entry Opportunity Date for PREZCOBIX
Generic Entry Date for PREZCOBIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for PREZCOBIX

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;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for PREZCOBIX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
7,939,553 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
8,486,942 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
8,383,655 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
8,088,770 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
8,067,449 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
9,139,541 Modulators of pharmacokinetic properties of therapeutics ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for PREZCOBIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016000103 Germany ➤ Try a Free Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119
0860 Netherlands ➤ Try a Free Trial PRODUCT 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
2016039 Lithuania ➤ Try a Free Trial PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
16/061 Ireland ➤ Try a Free Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2016038 Lithuania ➤ Try a Free Trial PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
90001-0 Sweden ➤ Try a Free Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Julphar
QuintilesIMS
Daiichi Sankyo
AstraZeneca
Chubb
US Department of Justice
US Army
Federal Trade Commission

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