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Serving hundreds of leading biopharmaceutical companies globally:

Teva
US Department of Justice
Moodys
Mallinckrodt
Federal Trade Commission
Chinese Patent Office
Daiichi Sankyo
Covington
UBS

Generated: July 15, 2018

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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are five drug master file entries for cobicistat; darunavir ethanolate. Two suppliers are listed for this compound.
Summary for cobicistat; darunavir ethanolate

US Patents and Regulatory Information for cobicistat; darunavir ethanolate

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 cobicistat; darunavir ethanolate

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

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Non-Orange Book US Patents for 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
7,939,553 Modulators of pharmacokinetic properties of therapeutics ➤ Sign Up
8,067,449 Modulators of pharmacokinetic properties of therapeutics ➤ Sign Up
8,088,770 Modulators of pharmacokinetic properties of therapeutics ➤ Sign Up
8,383,655 Modulators of pharmacokinetic properties of therapeutics ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for cobicistat; darunavir ethanolate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2 5024-2015 Slovakia ➤ Sign Up PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/830 20130527
0860 Netherlands ➤ Sign Up 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
/2016 Austria ➤ Sign Up PRODUCT 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
90002-8 Sweden ➤ Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cipla
US Department of Justice
Fish and Richardson
Farmers Insurance
Chinese Patent Office
Deloitte
QuintilesIMS
US Army

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.