Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

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Cobicistat; darunavir - Generic Drug Details

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

Cobicistat; darunavir is the generic ingredient in two branded drugs marketed by Janssen Prods and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for cobicistat; darunavir
International Patents:334
US Patents:17
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 5
Suppliers / Packagers: 3
Clinical Trials: 40
DailyMed Link:cobicistat; darunavir at DailyMed
Recent Clinical Trials for cobicistat; darunavir

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SponsorPhase
Janssen Pharmaceutica N.V., BelgiumPhase 1
Southampton Healthcare, Inc.Phase 4
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludPhase 4

See all cobicistat; darunavir clinical trials

US Patents and Regulatory Information for cobicistat; darunavir

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 TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Prods SYMTUZA cobicistat; darunavir ethanolate; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for cobicistat; darunavir

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

Supplementary Protection Certificates for cobicistat; darunavir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487166 CA 2017 00004 Denmark   Start Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
2049506 2015C/058 Belgium   Start Trial PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001
2049506 61/2015 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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