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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Moodys
Daiichi Sankyo
QuintilesIMS
Accenture
Citi
Federal Trade Commission
Chubb
Argus Health

Generated: June 24, 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.
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 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
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
8,871,271 Method and composition for pharmaceutical product ➤ Try a Free Trial
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Try a Free Trial
5,210,085 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Try a Free Trial
5,276,151 Method of synthesis of 1,3-dioxolane nucleosides ➤ 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
01C/001 Belgium ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
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
C021/2005 Ireland ➤ Try a Free Trial SPC021/2005: 20090811, EXPIRES: 20200220
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Julphar
Moodys
Boehringer Ingelheim
Healthtrust
Farmers Insurance
Harvard Business School
Teva
QuintilesIMS

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