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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Cipla
Colorcon
Baxter
Fuji
QuintilesIMS
Boehringer Ingelheim
Harvard Business School
Chubb
Healthtrust

Generated: February 20, 2018

DrugPatentWatch Database Preview

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, Aurobindo Pharma Ltd, and Teva Pharms Usa, and is included in eight NDAs. There are twenty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are seventeen drug master file entries for emtricitabine. Four suppliers are listed for this compound. There are ten tentative approvals for this compound.
Medical Subject Heading (MeSH) Categories for emtricitabine
Tentative approvals for EMTRICITABINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial200MGCAPSULE; ORAL
➤ Try a Free Trial➤ Try a Free Trial200MG; 300MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial200MGCAPSULE; ORAL

US Patents and Regulatory Information for emtricitabine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Aurobindo Pharma Ltd EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 090513-001 Jan 26, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-002 Mar 10, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead Sciences Inc COMPLERA emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate TABLET;ORAL 202123-001 Aug 10, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for emtricitabine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead EMTRIVA emtricitabine SOLUTION;ORAL 021896-001 Sep 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead EMTRIVA emtricitabine CAPSULE;ORAL 021500-001 Jul 2, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Try a Free Trial
7,053,100 Therapeutic nucleosides ➤ Try a Free Trial
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Try a Free Trial
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Try a Free Trial
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues ➤ Try a Free Trial
7,160,999 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Try a Free Trial
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane ➤ Try a Free Trial
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Try a Free Trial
5,814,639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Try a Free Trial
5,892,025 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for emtricitabine

Supplementary Protection Certificates for emtricitabine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0032 France ➤ Try a Free Trial PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
C/GB08/022 United Kingdom ➤ Try a Free Trial PRODUCT 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
853 Luxembourg ➤ Try a Free Trial PRODUCT 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
C0021 France ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0148 Netherlands ➤ Try a Free Trial 300148, 20110131, EXPIRES: 20160130
0768 Netherlands ➤ Try a Free Trial PRODUCT 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
C0020 France ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0781 Netherlands ➤ Try a Free Trial PRODUCT 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
2004 Austria ➤ Try a Free Trial PRODUCT 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
0851 Netherlands ➤ Try a Free Trial PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Moodys
Cipla
Cantor Fitzgerald
McKesson
Covington
Federal Trade Commission
Deloitte
Cerilliant

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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