Cabotegravir Patent Expiration

Cabotegravir was first introduced by Viiv Healthcare Co in its drug Apretude on Dec 20, 2021.


Cabotegravir Patents

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

Filter patents by

NEW
Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Apretude US11224597 Pharmaceutical compositions Sep 15, 2031 Viiv Hlthcare
Apretude US12138264 Pharmaceutical compositions Sep 15, 2031 Viiv Hlthcare
Apretude US8410103 (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent Feb 04, 2031 Viiv Hlthcare
Apretude US10927129 N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity Apr 28, 2026

(Expired)

Viiv Hlthcare



Cabotegravir's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List



Clinical Trials

Recent Clinical Trials on Cabotegravir:

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
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Sep 1, 2026)
PHASE3
A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY) ViiV Healthcare NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants ViiV Healthcare NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants ViiV Healthcare NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults ViiV Healthcare NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) NA COMPLETED
(Jul 1, 2026)
PHASE3
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV) ViiV Healthcare NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus) ViiV Healthcare NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT Africa Health Research Institute NA RECRUITING
(Jul 1, 2026)
PHASE3
Combatting HIV Or Other STIs Early (CHOOSE) Westat NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Cabotegravir-Hormone PK/PD Interactions for HIV Prevention Johns Hopkins University NA RECRUITING
(Jul 1, 2026)
PHASE1
A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants Janssen Research & Development, LLC NA COMPLETED
(May 1, 2026)
PHASE1
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age National Institute of Allergy and Infectious Diseases (NIAID) NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy ViiV Healthcare NA COMPLETED
(May 1, 2026)
PHASE3
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1 ViiV Healthcare NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
PathToScale: The PERSIST Trial Georgetown University NA RECRUITING
(Mar 1, 2026)


Cabotegravir Generic API Manufacturers

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