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Last Updated: March 28, 2024

Efavirenz - Generic Drug Details


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What are the generic sources for efavirenz and what is the scope of freedom to operate?

Efavirenz is the generic ingredient in eight branded drugs marketed by Aurobindo Pharma, Bristol Myers Squibb, Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Mylan, Strides Pharma, Gilead Sciences, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, Teva Pharms Usa, and Mylan Labs Ltd, and is included in twenty-four 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. Nine suppliers are listed for this compound. There are eighteen tentative approvals for this compound.

Drug Prices for efavirenz

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Recent Clinical Trials for efavirenz

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CelerionPhase 1
Reata Pharmaceuticals, Inc.Phase 1
altasciencesPhase 1

See all efavirenz clinical trials

Generic filers with tentative approvals for EFAVIRENZ
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial200MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial100MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for EFAVIRENZ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUSTIVA Capsules efavirenz 50 mg, 100 mg and 200 mg 020972 1 2016-11-03
SUSTIVA Tablets efavirenz 600 mg 021360 1 2009-04-09

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
Macleods Pharms Ltd EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 204287-001 Sep 13, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203041-001 Sep 4, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

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 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-001 Sep 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SUSTIVA efavirenz TABLET;ORAL 021360-001 Feb 1, 2002 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-002 Sep 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
>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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