.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Chubb
AstraZeneca
Johnson and Johnson
Healthtrust
Queensland Health
Farmers Insurance
QuintilesIMS
Fuji
McKinsey
Cantor Fitzgerald

Generated: December 18, 2017

DrugPatentWatch Database Preview

TRUVADA Drug Profile

« Back to Dashboard

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 twelve patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and twenty-three patent family members in forty-five countries and twenty-five supplementary protection certificates in nine 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-002Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-004Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-004Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-002Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-003Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
GileadTRUVADAemtricitabine; tenofovir disoproxil fumarateTABLET;ORAL021752-004Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges for TRUVADA

Drugname Dosage Strength RLD Submissiondate
emtricitabine and tenofovir disoproxil fumarateTablets100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mgTruvada5/19/2017
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
5,892,025 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,931,679 Foldable stand for a hammock► Subscribe
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► Subscribe
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
7,053,100Therapeutic nucleosides► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: TRUVADA

Country Document Number Estimated Expiration
China100396785► Subscribe
Hong Kong1026419► Subscribe
Canada2481078► Subscribe
Hungary9302377► Subscribe
Romania119365► Subscribe
JapanH06505725► Subscribe
Iceland7977► Subscribe
China100420443► Subscribe
Spain2308136► Subscribe
Australia2009200414► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: TRUVADA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894/02Switzerland► SubscribePRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
C0073France► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
433Luxembourg► Subscribe91433, EXPIRES: 20220725
C/GB04/016United Kingdom► SubscribePRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
0513200/01Switzerland► SubscribePRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
6Finland► Subscribe
0915894/01Switzerland► SubscribePRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
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.
C0071France► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Cipla
Medtronic
Queensland Health
Moodys
Dow
Johnson and Johnson
Deloitte
Covington
Julphar

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot