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Serving leading biopharmaceutical companies globally:

Medtronic
Fuji
Cantor Fitzgerald
QuintilesIMS
McKesson
Merck
Dow
Novartis
Express Scripts
Baxter

Generated: October 21, 2017

DrugPatentWatch Database Preview

EMTRIVA Drug Profile

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What is the patent landscape for Emtriva, and what generic Emtriva alternatives are available?

Emtriva is a drug marketed by Gilead and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-six patent family members in thirty-four countries and nineteen supplementary protection certificates in six countries.

The generic ingredient in EMTRIVA is emtricitabine. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.

Summary for Tradename: EMTRIVA

US Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list4
Bulk Api Vendors: see list81
Clinical Trials: see list6
Patent Applications: see list3,267
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EMTRIVA 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
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: EMTRIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 2005► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 2005► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for EMTRIVA

Drugname Dosage Strength RLD Submissiondate
emtricitabineCapsules200 mgEmtriva 7/16/2012

Non-Orange Book Patents for Tradename: EMTRIVA

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
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
6,931,679 Foldable stand for a hammock► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane► Subscribe
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane► Subscribe
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds► Subscribe
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues► 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: EMTRIVA

Country Document Number Estimated Expiration
Austria219366► Subscribe
United Kingdom9104741► Subscribe
Greece950300024► Subscribe
Australia1561792► Subscribe
World Intellectual Property Organization (WIPO)9215308► Subscribe
Hungary227823► Subscribe
HungaryT64844► Subscribe
Canada2481078► Subscribe
Japan2002012591► Subscribe
Australia4474599► 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: EMTRIVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
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
C/GB08/022United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213
0851Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
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
C0032France► SubscribePRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
073Luxembourg► Subscribe91073, EXPIRES: 20160131
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Baxter
McKesson
Moodys
Cerilliant
Daiichi Sankyo
Colorcon
US Department of Justice
UBS
Harvard Business School

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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