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STRIBILD Drug Profile

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Which patents cover Stribild, and what substitute generic drugs are available?

Stribild is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are fifteen patents protecting this drug.

This drug has four hundred and seventy-eight patent family members in forty-nine countries.

The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.

Applicant Tradename Generic Name Dosage NDA Approval Date 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, 2012RXYesYes8,633,219► SubscribeY ► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes9,457,036► SubscribeY ► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes7,635,704► SubscribeYY ► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes5,977,089*PED► SubscribeY► Subscribe
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYesYes8,981,103► SubscribeYY ► Subscribe
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Expired Patents for Tradename: STRIBILD

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 20125,814,639*PED► Subscribe
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Non-Orange Book Patents for Tradename: STRIBILD

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
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
8,088,770Modulators of pharmacokinetic properties of therapeutics► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane► Subscribe
7,939,553Modulators 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 Tradename: STRIBILD

Country Document Number Estimated Expiration
TaiwanI248928► Subscribe
Japan4173202► Subscribe
Hong Kong1079122► Subscribe
Japan5554300► Subscribe
Russian Federation2004121464► 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: STRIBILD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00624Netherlands► SubscribePRODUCT NAME: ELVITEGRAVIR IN ALLE VORMEN ZOALS; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130524
6Finland► Subscribe
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
0780Netherlands► SubscribePRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
2008 00023Denmark► Subscribe
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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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