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Serving 500+ biopharmaceutical companies globally:

Citi
Julphar
Farmers Insurance
Baxter
Mallinckrodt
McKesson
Queensland Health
Argus Health
Chinese Patent Office
Express Scripts

Generated: August 23, 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 two Paragraph IV challenges.

This drug has three hundred and seven 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 list182
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, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-002Mar 10, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 2016RXYesNo► Subscribe► 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;ORAL021752-002Mar 10, 2016► Subscribe► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004► Subscribe► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004► Subscribe► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-003Mar 10, 2016► Subscribe► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 2016► Subscribe► Subscribe
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Paragraph IV activity 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
5,914,400 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
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues► Subscribe
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► 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
Spain2187989► Subscribe
Norway324979► Subscribe
Denmark0984013► Subscribe
TaiwanI224103► Subscribe
HungaryT64844► 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
2004Austria► SubscribePRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
0768Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2008 00023Denmark► Subscribe
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
6Finland► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
US Department of Justice
Farmers Insurance
Cipla
Boehringer Ingelheim
Citi
Julphar
Colorcon
Novartis
Johnson and Johnson

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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