Efavirenz Patent Expiration

Efavirenz is used for managing HIV infection in combination with other antiviral drugs. It was first introduced by Bristol Myers Squibb Co in its drug Sustiva on Sep 17, 1998. 9 different companies have introduced drugs containing Efavirenz.


Efavirenz Patents

Given below is the list of patents protecting Efavirenz, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Sustiva US6238695

(Pediatric)

Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants Oct 06, 2019

(Expired)

Bristol Myers Squibb
Sustiva US6555133

(Pediatric)

Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants Oct 06, 2019

(Expired)

Bristol Myers Squibb
Sustiva US6238695 Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants Apr 06, 2019

(Expired)

Bristol Myers Squibb
Sustiva US6555133 Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants Apr 06, 2019

(Expired)

Bristol Myers Squibb
Sustiva US6639071

(Pediatric)

Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Aug 14, 2018

(Expired)

Bristol Myers Squibb
Sustiva US6939964

(Pediatric)

Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Jul 20, 2018

(Expired)

Bristol Myers Squibb
Sustiva US6639071 Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Feb 14, 2018

(Expired)

Bristol Myers Squibb
Sustiva US6939964 Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Jan 20, 2018

(Expired)

Bristol Myers Squibb
Sustiva US5663169

(Pediatric)

Benzoxazinones as inhibitors of HIV reverse transcriptase Mar 02, 2015

(Expired)

Bristol Myers Squibb
Sustiva US5663169 Benzoxazinones as inhibitors of HIV reverse transcriptase Sep 02, 2014

(Expired)

Bristol Myers Squibb
Sustiva US5519021

(Pediatric)

Benzoxazinones as inhibitors of HIV reverse transcriptase Nov 21, 2013

(Expired)

Bristol Myers Squibb
Sustiva US5519021 Benzoxazinones as inhibitors of HIV reverse transcriptase May 21, 2013

(Expired)

Bristol Myers Squibb
Sustiva US5811423 Benzoxazinones as inhibitors of HIV reverse transcriptase Aug 07, 2012

(Expired)

Bristol Myers Squibb



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Efavirenz's patents.

Given below is the list recent legal activities going on the following patents of Efavirenz.

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 29 Apr, 2003 US6555133
Recordation of Patent Grant Mailed 29 Apr, 2003 US6555133
Issue Notification Mailed 10 Apr, 2003 US6555133
Receipt into Pubs 14 Mar, 2003 US6555133
Receipt into Pubs 06 Mar, 2003 US6555133
Receipt into Pubs 03 Mar, 2003 US6555133
Application Is Considered Ready for Issue 28 Feb, 2003 US6555133
Issue Fee Payment Received 19 Feb, 2003 US6555133
Issue Fee Payment Verified 19 Feb, 2003 US6555133
Receipt into Pubs 11 Feb, 2003 US6555133


Efavirenz's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Efavirenz:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Effects of Kudzu Root (Gegen) on Drug-Metabolizing Enzymes and Blood Clotting in Healthy Volunteers Chinese University of Hong Kong NA COMPLETED
(Sep 1, 2026)
PHASE1
Efavirenz for the Treatment of Creutzfeldt-Jakob Disease Xuanwu Hospital, Beijing NA RECRUITING
(Aug 1, 2026)
PHASE3
Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants Vertex Pharmaceuticals Incorporated NA COMPLETED
(Aug 1, 2026)
PHASE1
Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Jul 1, 2026)
PHASE1
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Jul 1, 2026)
PHASE3
Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults ANRS, Emerging Infectious Diseases NA COMPLETED
(Jun 1, 2026)
PHASE2
Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART ANRS, Emerging Infectious Diseases NA COMPLETED
(Jun 1, 2026)
PHASE3
Tuberculosis Clinical Trials Consortium Study 35 Centers for Disease Control and Prevention NA COMPLETED
(Jun 1, 2026)
PHASE1, PHASE2
Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129) French National Agency for Research on AIDS and Viral Hepatitis NA COMPLETED
(Apr 1, 2026)
PHASE3
Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load French National Agency for Research on AIDS and Viral Hepatitis NA COMPLETED
(Apr 1, 2026)
PHASE3
Telaprevir in HIV-HCV Coinfected Patients Who Had Previously Failed a Peginterferon-Ribavirin Regimen ANRS, Emerging Infectious Diseases NA COMPLETED
(Apr 1, 2026)
PHASE2


Efavirenz Generic API Manufacturers

Several generic applications have been filed for Efavirenz. The first generic version for Efavirenz was by Mylan Pharmaceuticals Inc and was approved on Feb 17, 2016. And the latest generic version is by Macleods Pharmaceuticals Ltd and was approved on May 10, 2024.

Given below is the list of companies who have filed for Efavirenz generic, along with the locations of their manufacturing plants worldwide.


Efavirenz News

Brazil Could Save $600 Million Over Five Years by Producing Generic Versions of Patented AIDS Medications

16 Dec, 2025

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