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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Colorcon
Chubb
Merck
Julphar
Farmers Insurance
US Army
Moodys
Queensland Health

Generated: April 21, 2018

DrugPatentWatch Database Preview

Efavirenz; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic drug sources for efavirenz; emtricitabine; tenofovir disoproxil fumarate and what is the scope of efavirenz; emtricitabine; tenofovir disoproxil fumarate patent protection?

Efavirenz; emtricitabine; tenofovir disoproxil fumarate
is the generic ingredient in one branded drug marketed by Gilead Sciences and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efavirenz; emtricitabine; tenofovir disoproxil fumarate has four hundred and twenty-three patent family members in forty-seven countries.

There are twenty-six drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Five suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for efavirenz; emtricitabine; tenofovir disoproxil fumarate
Tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial600MG; 200MG; 300MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial600MG; 200MG; 300MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial300MGTABLET; ORAL

US Patents and Regulatory Information for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 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 efavirenz; emtricitabine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ 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 efavirenz; 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
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane ➤ Try a Free Trial
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Try a Free Trial
8,871,271 Method and composition for pharmaceutical product ➤ 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
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/041 United Kingdom ➤ Try a Free Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
C018/2008 Ireland ➤ Try a Free Trial SPC018/2008: 20090811, EXPIRES: 20220724
C0032 France ➤ Try a Free Trial PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
6 Finland ➤ Try a Free Trial
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:

Cipla
Deloitte
Baxter
US Army
Julphar
Dow
Chinese Patent Office
Express Scripts
Fish and Richardson

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