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Efavirenz; emtricitabine; tenofovir disoproxil fumarateis the generic ingredient in two branded drugs marketed by Gilead Sciences, Aurobindo Pharma Ltd, Cipla, and Teva Pharms Usa, and is included in four 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-nine patent family members in forty-three countries.
There are twenty-six drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Two suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for efavirenz; emtricitabine; tenofovir disoproxil fumarate
|Drug Master File Entries:||26|
|Suppliers / Packagers:||2|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for efavirenz; emtricitabine; tenofovir disoproxil fumarate|
|DailyMed Link:||efavirenz; emtricitabine; tenofovir disoproxil fumarate at DailyMed|
Recent Clinical Trials for efavirenz; emtricitabine; tenofovir disoproxil fumarate
Identify potential brand extensions & 505(b)(2) entrants
|University of Alberta||Phase 4|
|Yu-Jay Corp.||Phase 3|
|University of British Columbia||Phase 4|
Generic filers with tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for efavirenz; emtricitabine; tenofovir disoproxil fumarate
|ATRIPLA||TABLET;ORAL||efavirenz; emtricitabine; tenofovir disoproxil fumarate||021937||2008-12-29|
|Country||Patent Number||Estimated Expiration|
|South Korea||100381705||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|0513200||7/2004||Austria||Start 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||SPC/GB04/016||United Kingdom||Start 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||300148||Netherlands||Start Trial||300148, 20110131, EXPIRES: 20160130|
|0513200||SZ 7/2004||Austria||Start Trial|
|0915894||08C0020||France||Start Trial||PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213|
|0513200||122004000015||Germany||Start Trial||PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024|
|0915894||SPC/GB08/033||United Kingdom||Start Trial||PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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