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Serving 500+ biopharmaceutical companies globally:

Fuji
Queensland Health
McKinsey
Mallinckrodt
Farmers Insurance
Chinese Patent Office
Merck
US Army
Julphar
Citi

Generated: June 27, 2017

DrugPatentWatch Database Preview

TRUVADA Drug Profile

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Which patents cover Truvada, and when can generic versions of Truvada launch?

Truvada is a drug marketed by Gilead and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and six patent family members in forty-five countries.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

Summary for Tradename: TRUVADA

Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list11
Clinical Trials: see list181
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TRUVADA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes5,935,946*PED► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes5,977,089*PED► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-002Mar 10, 2016RXYesNo5,922,695► SubscribeY ► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 2016RXYesNo5,977,089*PED► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 2016RXYesNo5,935,946*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: TRUVADA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-003Mar 10, 20165,814,639*PED► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-002Mar 10, 20165,814,639*PED► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 20047,402,588*PED► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 20045,814,639*PED► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 20165,814,639*PED► Subscribe
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Paragraph IV activity for: TRUVADA

Drugname Dosage Strength RLD Submissiondate
emtricitabine and tenofovir disoproxil fumarateTablets200 mg/300 mgTruvada9/26/2008

Non-Orange Book Patents for Tradename: TRUVADA

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
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,914,400 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,728,575 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 Tradename: TRUVADA

Country Document Number Estimated Expiration
Austria219366► Subscribe
Japan2008208126► Subscribe
South Africa9201658► Subscribe
JapanH05505794► Subscribe
European Patent Office3025718► 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: TRUVADA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
0852Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
C/GB05/041United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
C0021France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C0032France► SubscribePRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Fuji
Deloitte
Accenture
Covington
Novartis
Cerilliant
Queensland Health
Dow
McKinsey

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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