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Serving leading biopharmaceutical companies globally:

US Department of Justice
US Army
AstraZeneca
McKesson
Fuji
Deloitte
Colorcon
Medtronic
Mallinckrodt
Dow

Generated: December 12, 2017

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EMTRIVA Drug Profile

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When do Emtriva patents expire, and what generic 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
GileadEMTRIVAemtricitabineCAPSULE;ORAL021500-001Jul 2, 2003RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
GileadEMTRIVAemtricitabineSOLUTION;ORAL021896-001Sep 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
GileadEMTRIVAemtricitabineCAPSULE;ORAL021500-001Jul 2, 2003RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
GileadEMTRIVAemtricitabineCAPSULE;ORAL021500-001Jul 2, 2003RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
GileadEMTRIVAemtricitabineSOLUTION;ORAL021896-001Sep 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
GileadEMTRIVAemtricitabineSOLUTION;ORAL021896-001Sep 28, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: EMTRIVA

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

Drugname Dosage Strength RLD Submissiondate
emtricitabineCapsules200 mgEmtriva7/16/2012

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
7,160,999Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,931,679 Foldable stand for a hammock► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,069,252 Method 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
7,053,100Therapeutic nucleosides► Subscribe
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane► 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
Czech Republic282747► Subscribe
South Africa9201658► Subscribe
Japan2011102308► Subscribe
Australia1367692► Subscribe
Finland116222► Subscribe
Hungary227485► Subscribe
Japan2002220388► Subscribe
Australia7300491► Subscribe
China1109108► Subscribe
World Intellectual Property Organization (WIPO)9111186► 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/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
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
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
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
853Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET L'EMTRICITABINE
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
073Luxembourg► Subscribe91073, EXPIRES: 20160131
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
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
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Medtronic
McKesson
Merck
Harvard Business School
Dow
Queensland Health
Fish and Richardson
Chubb

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