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Generated: September 25, 2017

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Emtricitabine - Generic Drug Details

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What are the generic drug sources for emtricitabine and what is the scope of emtricitabine patent protection?

Emtricitabine
is the generic ingredient in six branded drugs marketed by Gilead, Gilead Sciences Inc, and Teva Pharms Usa, and is included in seven NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Emtricitabine has one hundred and seventy patent family members in thirty-four countries.

There are sixteen drug master file entries for emtricitabine. Four suppliers are listed for this compound. There are ten tentative approvals for this compound.

Summary for Generic Name: emtricitabine

Tradenames:6
Patents:21
Applicants:3
NDAs:7
Drug Master File Entries: see list16
Suppliers / Packagers: see list4
Bulk Api Vendors: see list68
Clinical Trials: see list358
Patent Applications: see list5,672
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:emtricitabine at DailyMed

Tentative approvals for EMTRICITABINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe200MGCAPSULE; ORAL
► Subscribe► Subscribe200MG; 300MGTABLET; ORAL
► Subscribe► Subscribe200MGCAPSULE; 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;ORAL021752-003Mar 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;ORAL021752-001Aug 2, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
COMPLERA
emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
TABLET;ORAL202123-001Aug 10, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead
TRUVADA
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-003Mar 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 Sciences Inc
ODEFSEY
emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
TABLET;ORAL208351-001Mar 1, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
DESCOVY
emtricitabine; tenofovir alafenamide fumarate
TABLET;ORAL208215-001Apr 4, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: emtricitabine

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
SOLUTION;ORAL021896-001Sep 28, 2005► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
CAPSULE;ORAL021500-001Jul 2, 2003► Subscribe► Subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: emtricitabine

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
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers► Subscribe
6,153,751 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
5,827,727 Method of resolution of 1,3-oxathiolane nucleoside enantiomers► Subscribe
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues► Subscribe
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► Subscribe
5,539,116 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
5,276,151 Method of synthesis of 1,3-dioxolane nucleosides► Subscribe
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds► 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

Country Document Number Estimated Expiration
Australia4031995► Subscribe
European Patent Office1808434► Subscribe
Finland20050672► Subscribe
Norway20065640► Subscribe
Brazil9205661► Subscribe
Finland923446► Subscribe
Japan4108645► Subscribe
South Africa9201658► Subscribe
New Zealand264621► Subscribe
Hungary211300► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0513200/01Switzerland► SubscribePRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
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
C0032France► SubscribePRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
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
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
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
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
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
0148Netherlands► Subscribe300148, 20110131, EXPIRES: 20160130
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
US Army
Queensland Health
Daiichi Sankyo
Teva
QuintilesIMS
Colorcon
US Department of Justice
Healthtrust
Fish and Richardson

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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