Emtricitabine Patent Expiration

Emtricitabine is Used for treating HIV infection in adults. It was first introduced by Gilead Sciences Inc in its drug Emtriva on Jul 2, 2003. 3 different companies have introduced drugs containing Emtricitabine.


Emtricitabine Patents

Given below is the list of patents protecting Emtricitabine, 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
Emtriva US6703396

(Pediatric)

Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Sep 09, 2021

(Expired)

Gilead
Emtriva US6642245

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane May 04, 2021

(Expired)

Gilead
Emtriva US6703396 Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Mar 09, 2021

(Expired)

Gilead
Emtriva US6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Nov 04, 2020

(Expired)

Gilead
Emtriva US5914331

(Pediatric)

Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Jan 02, 2018

(Expired)

Gilead
Emtriva US5914331 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Jul 02, 2017

(Expired)

Gilead
Emtriva US5814639

(Pediatric)

Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds Mar 29, 2016

(Expired)

Gilead
Emtriva US5814639 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds Sep 29, 2015

(Expired)

Gilead



Emtricitabine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Emtricitabine:

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
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 Gilead Sciences NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment Gilead Sciences NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection Gilead Sciences NA TERMINATED
(Aug 1, 2026)
PHASE3
A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(Aug 1, 2026)
PHASE2
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102) Gilead Sciences NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) Gilead Sciences NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants Jiangsu Aidea Pharmaceutical Group Co., Ltd. NA COMPLETED
(Aug 1, 2026)
PHASE1
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV Gilead Sciences NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646) Merck Sharp & Dohme LLC NA COMPLETED
(Aug 1, 2026)
PHASE1
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1 Gilead Sciences NA RECRUITING
(Aug 1, 2026)
PHASE2
Repurposing a Combination Antiretroviral Drug Therapy to Target Retrotransposons and Treat Early Alzheimer's Disease Brigham and Women's Hospital NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection Gilead Sciences NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France. ANRS, Emerging Infectious Diseases NA RECRUITING
(Jul 1, 2026)
PHASE3
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) ViiV Healthcare NA RECRUITING
(Jul 1, 2026)
PHASE2
Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study National University Hospital, Singapore NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens Gilead Sciences NA RECRUITING
(Jul 1, 2026)
PHASE3
Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions Jiangsu Aidea Pharmaceutical Group Co., Ltd. NA COMPLETED
(Jul 1, 2026)
PHASE1
Reducing Antiretroviral Treatments ANRS, Emerging Infectious Diseases NA TERMINATED
(Jun 1, 2026)
PHASE3
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF ViiV Healthcare NA COMPLETED
(Jun 1, 2026)
PHASE3
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy ViiV Healthcare NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy Gilead Sciences NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP) Gilead Sciences NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
The Women TDF-FTC Benchmark Study University of Washington NA COMPLETED
(May 1, 2026)
PHASE2
The Women TAF-FTC Benchmark Study University of Washington NA COMPLETED
(May 1, 2026)
PHASE2, PHASE3
Study of GS-3242 in Participants With HIV-1; Substudy-05 Gilead Sciences NA COMPLETED
(May 1, 2026)
PHASE1
Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients ANRS, Emerging Infectious Diseases NA COMPLETED
(Apr 1, 2026)
PHASE2
Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024) Merck Sharp & Dohme LLC NA TERMINATED
(Apr 1, 2026)
PHASE3
B/F/TAF to DTG/3TC Switch Study University of Nairobi NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3
Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed Gilead Sciences NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated Gilead Sciences NA TERMINATED
(Apr 1, 2026)
PHASE2, PHASE3
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 Gilead Sciences NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3


Emtricitabine Generic API Manufacturers

Several generic applications have been filed for Emtricitabine. The first generic version for Emtricitabine was by Cipla Ltd and was approved on Jul 2, 2018. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Mar 15, 2023.

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