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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Cipla
Farmers Insurance
Moodys
Colorcon
Express Scripts
Dow
Healthtrust
Mallinckrodt
Teva

Generated: August 20, 2017

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Cobicistat - Generic Drug Details

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What are the generic drug sources for cobicistat and what is the scope of cobicistat freedom to operate?

Cobicistat
is the generic ingredient in four branded drugs marketed by Gilead Sciences Inc and Janssen Prods, and is included in four NDAs. There are twenty-six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are five drug master file entries for cobicistat. One supplier is listed for this compound.

Summary for Generic Name: cobicistat

Tradenames:4
Patents:26
Applicants:2
NDAs:4
Drug Master File Entries: see list5
Suppliers / Packagers: see list1
Bulk Api Vendors: see list23
Clinical Trials: see list76
Patent Applications: see list44
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:cobicistat at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cobicistat

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
9,139,541Modulators of pharmacokinetic properties of therapeutics► Subscribe
7,939,553Modulators 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 Ingredient: cobicistat

Country Document Number Estimated Expiration
European Patent Office2487164► Subscribe
HungaryE031707► Subscribe
Japan2009542696► Subscribe
HungaryS1600053► Subscribe
Eurasian Patent Organization200900155► 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: COBICISTAT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0859Netherlands► SubscribePRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2017 00002Denmark► SubscribePRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
2015000092Germany► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
0861Netherlands► SubscribePRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN EN DARUNAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN. IN HET BIJZONDER DARUNAVIRETHANOLAAT; REGISTRATION NO/DATE: EU/1/14/967 20141121
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Fuji
Argus Health
Healthtrust
Johnson and Johnson
AstraZeneca
Cerilliant
Fish and Richardson
Cipla
McKinsey

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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