EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details
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What are the generic drug sources for efavirenz; lamivudine; tenofovir disoproxil fumarate and what is the scope of patent protection?
Efavirenz; lamivudine; tenofovir disoproxil fumarate
is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Laurus, Macleods Pharms Ltd, Mylan Labs Ltd, and Mylan, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.Two suppliers are listed for this compound.
Summary for EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 5 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 28 |
DailyMed Link: | EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed |
Recent Clinical Trials for EFAVIRENZ; LAMIVUDINE; 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 |
Professor Francois Venter | Phase 3 |
Yu-Jay Corp. | Phase 3 |
See all EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials
Pharmacology for EFAVIRENZ; LAMIVUDINE; 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, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 022343-001 | Aug 15, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Macleods Pharms Ltd | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 210649-001 | Mar 15, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Laurus | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 212786-001 | May 14, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Labs Ltd | SYMFI | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 022142-001 | Mar 22, 2018 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Laurus | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 213038-001 | May 14, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan | SYMFI LO | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 208255-001 | Feb 5, 2018 | AB | RX | Yes | Yes | ⤷ 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 |
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