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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Chubb
Cipla
Fuji
US Department of Justice
Federal Trade Commission
Accenture
Fish and Richardson
Johnson and Johnson

Generated: November 21, 2017

DrugPatentWatch Database Preview

Emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic sources for emtricitabine; tenofovir disoproxil fumarate and what is the scope of emtricitabine; tenofovir disoproxil fumarate freedom to operate?

Emtricitabine; tenofovir disoproxil fumarate
is the generic ingredient in two branded drugs marketed by Gilead and Teva Pharms Usa, and is included in two NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Emtricitabine; tenofovir disoproxil fumarate has three hundred and twenty-five patent family members in forty-five countries and twenty-five supplementary protection certificates in nine countries.

There are sixteen drug master file entries for emtricitabine; tenofovir disoproxil fumarate. Eleven suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for emtricitabine; tenofovir disoproxil fumarate

Tentative approvals for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant Application No. Strength Dosage Form
u► Subscribe200MG; 300MGTABLET; ORAL
u► Subscribe200MG; 300MGTABLET; ORAL
u► Subscribe200MG; 300MGTABLET; ORAL
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;ORAL021752-004Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 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;ORAL021752-002Mar 10, 2016RXYesNo► 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;ORAL021752-003Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: emtricitabine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 2004► Subscribe► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-002Mar 10, 2016► Subscribe► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-003Mar 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;ORAL021752-002Mar 10, 2016► Subscribe► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 2016► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: emtricitabine; tenofovir disoproxil fumarate

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
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► Subscribe
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane► Subscribe
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,814,639 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
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,931,679 Foldable stand for a hammock► 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 Ingredient: emtricitabine; tenofovir disoproxil fumarate

Country Document Number Estimated Expiration
Australia679649► Subscribe
Finland20030933► Subscribe
JapanH10147586► Subscribe
Japan2015098488► Subscribe
Taiwan201268► Subscribe
Eurasian Patent Organization200501134► Subscribe
China1264387► Subscribe
Hong Kong1051373► Subscribe
Norway20083728► Subscribe
Norway2008010► 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: EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
178Luxembourg► Subscribe91178, EXPIRES: 20200221
073Luxembourg► Subscribe91073, EXPIRES: 20160131
C0032France► SubscribePRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
6Finland► Subscribe
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
C0021France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C021/2005Ireland► SubscribeSPC021/2005: 20090811, EXPIRES: 20200220
0781Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
433Luxembourg► Subscribe91433, EXPIRES: 20220725
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
AstraZeneca
Mallinckrodt
Chinese Patent Office
UBS
Accenture
Covington
Johnson and Johnson
Citi

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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