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Serving leading biopharmaceutical companies globally:

UBS
Colorcon
McKesson
Harvard Business School
Federal Trade Commission
Medtronic
Daiichi Sankyo
Cantor Fitzgerald
Teva
Baxter

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,592,397

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Which drugs does patent 8,592,397 protect, and when does it expire?


Patent 8,592,397 protects STRIBILD, COMPLERA, ATRIPLA, and TRUVADA, and is included in four NDAs. There have been zero Paragraph IV challenges on Truvada, Complera, and Atripla.

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

Summary for Patent: 8,592,397

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)-pyrimi- din-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:12/195,161
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS 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, 2012RXYesYes► Subscribe► SubscribeY TREATMENT OF HIV INFECTION
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY TREATMENT OF HIV INFECTION
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes► Subscribe► SubscribeY TREATMENT OF HIV-1 INFECTION IN ADULTS
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY TREATMENT OF HIV
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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Non-Orange Book Patents for Patent: 8,592,397

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
8,716,264Compositions and methods for combination antiviral therapy► Subscribe
9,457,036Compositions 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: 8,592,397

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Japan2010120957► Subscribe
Japan2014037430► Subscribe
South Korea20090053867► Subscribe
South Korea20080032014► Subscribe
South Korea20050092755► Subscribe
South Korea100860136► Subscribe
Japan2017057232► Subscribe
Japan2015098488► Subscribe
Japan2006515624► Subscribe
Japan4996241► Subscribe
This preview shows a limited data set
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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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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Colorcon
Daiichi Sankyo
Boehringer Ingelheim
McKinsey
Cipla
Farmers Insurance
Medtronic
Mallinckrodt
UBS

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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