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Details for Patent: 8,716,264

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Patent 8,716,264 protects STRIBILD, COMPLERA, ATRIPLA, and TRUVADA, and is included in four NDAs. There have been zero Paragraph IV challenges on Complera, Atripla, and Truvada. There are eleven tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has fifty patent family members in twenty-nine countries.

Summary for Patent: 8,716,264

Title:Compositions and methods for combination antiviral therapy
Abstract: The present invention relates to therapeutic combinations of [2-(6-amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid diisopropoxycarbonyloxymethyl ester (tenofovir disoproxil fumarate, Viread.RTM.) and (2R,5S,cis)-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)- -pyrimidin-2-one (emtricitabine, Emtriva.TM., (-)-cis FTC) and their physiologically functional derivatives. The combinations may be useful in the treatment of HIV infections, including infections with HIV mutants bearing resistance to nucleoside and/or non-nucleoside inhibitors. The present invention is also concerned with pharmaceutical compositions and formulations of said combinations of tenofovir disoproxil fumarate and emtricitabine, and their physiologically functional derivatives, as well as therapeutic methods of use of those compositions and formulations.
Inventor(s): Dahl; Terrence C. (Sunnyvale, CA), Menning; Mark M. (San Francisco, CA), Oliyai; Reza (San Carlos, CA)
Assignee: Gilead Sciences, Inc. (Foster City, CA)
Application Number:12/204,174
Patent Claim Types:
see list of patent claims
Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012RXYes8,716,264► subscribeY TREATMENT OF HIV INFECTION
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYes8,716,264► subscribeY TREATMENT OF HIV INFECTION
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes8,716,264► subscribeY TREATMENT OF HIV INFECTION
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Non-Orange Book Patents for Patent: 8,716,264

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
8,592,397Compositions and methods for combination antiviral therapy► 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 Patent: 8,716,264

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Ukraine81797► subscribe
Taiwan200425895► subscribe
TaiwanI355270► 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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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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