Efavirenz - Generic Drug Details
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What are the generic sources for efavirenz and what is the scope of patent protection?
Efavirenz
is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma, Bristol Myers Squibb, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Strides Pharma, Gilead Sciences, Hetero Labs Ltd V, Laurus, Teva Pharms Usa, and Mylan Labs Ltd, and is included in twenty-six NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are twenty-six drug master file entries for efavirenz. Eight suppliers are listed for this compound. There are eighteen tentative approvals for this compound.
Summary for efavirenz
US Patents: | 7 |
Tradenames: | 9 |
Applicants: | 13 |
NDAs: | 26 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 8 |
Raw Ingredient (Bulk) Api Vendors: | 107 |
Clinical Trials: | 429 |
Patent Applications: | 7,961 |
Drug Prices: | Drug price trends for efavirenz |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for efavirenz |
What excipients (inactive ingredients) are in efavirenz? | efavirenz excipients list |
DailyMed Link: | efavirenz at DailyMed |
Recent Clinical Trials for efavirenz
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Merck Sharp & Dohme LLC | Phase 3 |
Africa Health Research Institute | Phase 3 |
Takeda | Phase 1 |
Generic filers with tentative approvals for EFAVIRENZ
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 200MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 100MG | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd Iii | EFAVIRENZ | efavirenz | TABLET;ORAL | 078886-001 | Apr 27, 2018 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cipla | EFAVIRENZ | efavirenz | TABLET;ORAL | 204766-001 | Jun 15, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-003 | Sep 17, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma Ltd | EFAVIRENZ | efavirenz | TABLET;ORAL | 077673-001 | Sep 21, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | EFAVIRENZ | efavirenz | CAPSULE;ORAL | 078064-002 | Dec 15, 2017 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Gilead Sciences | ATRIPLA | efavirenz; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 021937-001 | Jul 12, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-003 | Sep 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-002 | Sep 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-002 | Sep 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-001 | Sep 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | SUSTIVA | efavirenz | TABLET;ORAL | 021360-001 | Feb 1, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | SUSTIVA | efavirenz | CAPSULE;ORAL | 020972-003 | Sep 17, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
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