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Generated: December 16, 2017

DrugPatentWatch Database Preview

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

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What are the generic drug sources for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate and what is the scope of cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate freedom to operate?

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

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate has five hundred and sixty-five patent family members in fifty countries and fifty-seven supplementary protection certificates in fourteen countries.

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

Summary for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences IncSTRIBILDcobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarateTABLET;ORAL203100-001Aug 27, 2012► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil 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
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,892,025 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
9,139,541Modulators of pharmacokinetic properties of therapeutics► Subscribe
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,700,937 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
6,812,233 Therapeutic nucleosides► Subscribe
7,053,100Therapeutic nucleosides► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► 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 disoproxil fumarate

Country Document Number Estimated Expiration
Argentina049280► Subscribe
Australia3897097► Subscribe
Australia2008218186► Subscribe
Japan5554300► Subscribe
Japan2013213071► Subscribe
TaiwanI248928► Subscribe
HungaryT65548► Subscribe
China1554350► Subscribe
China1738628► Subscribe
South Korea0172590► 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 DISOPROXIL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008 00023Denmark► Subscribe
433Luxembourg► Subscribe91433, EXPIRES: 20220725
C0032France► SubscribePRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
9Finland► Subscribe
178Luxembourg► Subscribe91178, EXPIRES: 20200221
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
0915894/01Switzerland► SubscribePRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
2005 00032Denmark► Subscribe
90052-7Sweden► SubscribePRODUCT NAME: ELVITEGRAVIR ELLER ETT HYDRAT, ETT SOLVAT, EN TAUTOMER, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/830/001 20130524
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
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Serving leading biopharmaceutical companies globally:

Chubb
Citi
Johnson and Johnson
Julphar
Harvard Business School
Mallinckrodt
Daiichi Sankyo
US Department of Justice
Cipla
McKesson

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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