EFAVIRENZ Drug Patent Profile
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Which patents cover Efavirenz, and what generic alternatives are available?
Efavirenz is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Mylan, Strides Pharma, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, and Teva Pharms Usa. and is included in nineteen NDAs.
The generic ingredient in EFAVIRENZ is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.
Summary for EFAVIRENZ
Recent Clinical Trials for EFAVIRENZ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| altasciences | Phase 1 |
| Q2 Solutions | Phase 1 |
| Celerion | Phase 1 |
Pharmacology for EFAVIRENZ
Anatomical Therapeutic Chemical (ATC) Classes for EFAVIRENZ
US Patents and Regulatory Information for EFAVIRENZ
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | EFAVIRENZ | efavirenz | CAPSULE;ORAL | 078064-001 | Dec 15, 2017 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Laurus | EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE | efavirenz; lamivudine; tenofovir disoproxil fumarate | TABLET;ORAL | 213038-001 | May 14, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd Iii | EFAVIRENZ | efavirenz | TABLET;ORAL | 078886-001 | Apr 27, 2018 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aurobindo Pharma | EFAVIRENZ | efavirenz | TABLET;ORAL | 205322-001 | Aug 30, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for EFAVIRENZ
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Teva B.V. | Efavirenz Teva | efavirenz | EMEA/H/C/002352 Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older.Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz. |
Authorised | yes | no | no | 2012-01-09 | |
| Merck Sharp & Dohme B.V. | Stocrin | efavirenz | EMEA/H/C/000250 Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin. |
Authorised | no | no | no | 1999-05-28 | |
| Bristol-Myers Squibb Pharma EEIG | Sustiva | efavirenz | EMEA/H/C/000249 Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva. |
Authorised | no | no | no | 1999-05-28 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
