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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 three hundred and one patent family members in forty-three countries.
There are twenty-six drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Five 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|
|Finished Product Suppliers / Packagers:||5|
|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
|Yu-Jay Corp.||Phase 3|
|University of British Columbia||Phase 4|
|University of Alberta||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|
|Eurasian Patent Organization||200800033||Get Started Free|
|New Zealand||264621||Get Started Free|
|Germany||69233693||Get Started Free|
|Slovenia||1583542||Get Started Free|
|European Patent Office||2952181||Get Started Free|
|United Kingdom||9104741||Get Started Free|
|Taiwan||200425895||Get Started Free|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|0915894||08C0020||France||Get Started Free||PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213|
|0513200||122004000015||Germany||Get Started Free||PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024|
|0513200||7/2004||Austria||Get Started Free||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|
|0582455||2001C/001||Belgium||Get Started Free||PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120|
|0915894||SPC/GB08/033||United Kingdom||Get Started Free||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|
|0513200||SZ 7/2004||Austria||Get Started Free|
|0582455||C300032||Netherlands||Get Started Free||PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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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 verification 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.