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Last Updated: November 26, 2022

Efavirenz - Generic Drug Details


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What are the generic drug sources for efavirenz and what is the scope of patent protection?

Efavirenz is the generic ingredient in seven 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-three 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. Ten 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

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SponsorPhase
The Aurum Institute NPCPhase 1/Phase 2
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A
Jean-Pierre RoutyN/A

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Generic filers with tentative approvals for EFAVIRENZ
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing200MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing200MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET; 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
Bristol Myers Squibb SUSTIVA efavirenz CAPSULE;ORAL 020972-003 Sep 17, 1998 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203041-001 Sep 4, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma EFAVIRENZ efavirenz CAPSULE;ORAL 078064-002 Dec 15, 2017 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Aurobindo Pharma EFAVIRENZ efavirenz CAPSULE;ORAL 078064-003 Dec 15, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii EFAVIRENZ efavirenz TABLET;ORAL 078886-001 Apr 27, 2018 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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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