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 freedom to operate?
Efavirenz; emtricitabine; tenofovir disoproxil fumarate
is the generic ingredient in four branded drugs marketed by Gilead Sciences, Aurobindo Pharma, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, Teva Pharms Usa, Strides Pharma, and Mylan, and is included in nine NDAs. There are seven 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 one hundred and twenty-three patent family members in thirty-one countries.
Seven suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
International Patents: | 123 |
US Patents: | 7 |
Tradenames: | 4 |
Applicants: | 9 |
NDAs: | 9 |
Finished Product Suppliers / Packagers: | 7 |
Clinical Trials: | 39 |
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
Sponsor | Phase |
---|---|
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | N/A |
Yu-Jay Corp. | Phase 3 |
University of Alberta | Phase 4 |
See all EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials
Generic filers with tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 600MG; 200MG; 300MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 600MG | TABLET; ORAL |
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
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ATRIPLA | Tablets | efavirenz; emtricitabine; tenofovir disoproxil fumarate | 600 mg/200 mg/300 mg | 021937 | 1 | 2008-12-29 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Laurus | EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 213541-001 | Dec 22, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 091215-001 | Nov 9, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 203041-001 | Sep 4, 2018 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hetero Labs Ltd V | EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 203053-001 | Jan 24, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5409001 | ⤷ Sign Up | |
New Zealand | 564045 | Stable fixed-dose formulations containing a combination of antivirals (emtricitabine and tenofovir DF), method for producing thereof using dry granulation | ⤷ Sign Up |
Canada | 2512475 | COMPOSITIONS ET METHODES DESTINEES A UNE THERAPIE DE COMBINAISON ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY) | ⤷ Sign Up |
China | 102670629 | Compositions and methods for combination antiviral therapy | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0582455 | 2001C/001 | Belgium | ⤷ Sign Up | PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120 |
0582455 | C300032 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528 |
0582455 | 08C0021 | France | ⤷ Sign Up | PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213 |
0915894 | SPC/GB08/033 | United Kingdom | ⤷ Sign Up | 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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