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Generated: May 25, 2019

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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 two branded drugs marketed by Gilead Sciences, Aurobindo Pharma Ltd, and Teva Pharms Usa, and is included in three NDAs. There are nine 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 two hundred and ninety-seven patent family members in forty-three countries.

There are twenty-six drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Generic filers with 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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Aurobindo Pharma Ltd EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203041-001 Sep 4, 2018 AB RX No No ➤ 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 AB 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 AB 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 AB 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 AB 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 AB 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

Supplementary Protection Certificates for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200 C00513200/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
0513200 SPC/GB04/016 United Kingdom ➤ Try a Free Trial PRODUCT 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
0513200 91073 Luxembourg ➤ Try a Free Trial 91073, EXPIRES: 20160131
0513200 7/2004 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
0513200 SZ 7/2004 Austria ➤ Try a Free Trial
0582455 08C0021 France ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Moodys
US Army
US Department of Justice
Teva

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