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

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What are the generic drug sources, and freedom to operate, for cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate?

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.

This ingredient has four hundred and forty-three patent family members in fifty-eight countries.

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

Applicant Tradename Generic Name Dosage NDA Approval Date 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, 2015RXYesYes7,390,791► SubscribeYY ► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes8,148,374► SubscribeYY ► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes► Subscribe► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes8,981,103► SubscribeYY ► Subscribe
Gilead Sciences Inc
GENVOYA
cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL207561-001Nov 5, 2015RXYesYes5,914,331*PED► SubscribeY► 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, 20155,814,639*PED► 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
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane► Subscribe
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
9,139,541Modulators of pharmacokinetic properties of therapeutics► Subscribe
8,486,942Modulators of pharmacokinetic properties of therapeutics► Subscribe
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► 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
European Patent Office2272516► Subscribe
Slovenia2487161► Subscribe
Portugal2118082► Subscribe
Russian Federation2275361► Subscribe
Argentina042095► 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; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0803Netherlands► SubscribePRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
864Luxembourg► SubscribePRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20130527
00624Netherlands► SubscribePRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
073Luxembourg► Subscribe91073, EXPIRES: 20160131
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
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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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