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Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate - Generic Drug Details

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What are the generic sources for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate and what is the scope of cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate patent protection?

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate has four hundred and eighty-five patent family members in fifty-nine countries.

There are five drug master file entries for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate. Two suppliers are listed for this compound.

Summary for Generic Name: cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Tradenames:1
Patents:12
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packagers: see list2
Clinical Trials: see list946
Drug Prices:see low prices
DailyMed Link:cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate 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
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
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► SubscribeY► 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► Subscribe► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 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► SubscribeY► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

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
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
8,232,4014-oxoquinoline compound and use thereof as HIV integrase inhibitor► Subscribe
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane► Subscribe
6,931,679 Foldable stand for a hammock► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,210,085 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
9,139,541Modulators of pharmacokinetic properties of therapeutics► Subscribe
7,053,100Therapeutic nucleosides► Subscribe
8,088,770Modulators 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; elvitegravir; emtricitabine; tenofovir alafenamide fumarate

Country Document Number Estimated Expiration
HungaryS1300066► Subscribe
Hungary211344► Subscribe
Portugal2118082► Subscribe
Denmark2487166► Subscribe
Norway324979► Subscribe
Spain2345102► Subscribe
Denmark0574487► Subscribe
HungaryS1600053► Subscribe
South Korea101612642► Subscribe
Japan4108645► 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.

Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0780Netherlands► SubscribePRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
/2015Austria► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
2013 00058Denmark► SubscribePRODUCT NAME: ELVITEGRAVIR I ENHVER FORM SOM ER OMFATTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/13/830/001-002 20130524
/2016Austria► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121
0513200/01Switzerland► SubscribePRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
2013 00058Denmark► SubscribePRODUCT NAME: ELVITEGRAVIR ELLER ET HYDRAT, ET SOLVAT, EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2016040Lithuania► SubscribePRODUCT NAME: DARUNAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
/2016Austria► SubscribePRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123
2016038Lithuania► SubscribePRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
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
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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
McKesson
QuintilesIMS
Accenture
Moodys
Covington
McKinsey
US Army
Queensland Health
Daiichi Sankyo

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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