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Apretude · pharmadog

pharmadog
drugs
Apretude

drug

patient view →

cabotegravir LA

Marketedupdated 2mo ago

by ViiV Healthcare Company

Approved

community read0 votes

all catalysts(2)

drug expiry · 1

ViiV Healthcare UK Ltd — cabotegravir LA (Drug Expiry (US))

cabotegravir LA

patent expiry · 1

ViiV Healthcare UK Ltd — cabotegravir LA (Constraining Patent Expiry (US))

cabotegravir LA

News(0)

no news has mentioned this drug yet

brand

Apretude

generic

cabotegravir

indication

Human Immunodeficiency Virus (HIV) Infections (AIDS)

phase

marketed

Patent cliff

source: FDA Orange Book

first barrier falls

Jun 30, 2027

358 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (20)

Jul 18, 2038method-of-use (U-3348)US 12178815
Jul 18, 2038method-of-use (U-3348)US 12178815
Apr 13, 2032formulationUS 11389448
Apr 13, 2032formulationUS 11389448
Nov 27, 2031method-of-use (U-3348)US RE50189
Nov 27, 2031method-of-use (U-3348)US RE50189
Sep 15, 2031formulationUS 11224597
Sep 15, 2031formulationUS 11224597
Sep 15, 2031formulationUS 11224597
Sep 15, 2031formulationUS 12138264
Sep 15, 2031formulationUS 12138264
Sep 15, 2031formulationUS 12138264
Feb 4, 2031compositionUS 84101034.6y
Feb 4, 2031compositionUS 84101034.6y
Feb 4, 2031compositionUS 84101034.6y
Jun 30, 2027method-of-use (U-3405)US 11389447358d
Jun 30, 2027method-of-use (U-3405)US 11389447358d
Apr 28, 2026compositionUS 10927129
Apr 28, 2026compositionUS 10927129
Apr 28, 2026compositionUS 10927129

FDA exclusivities (3)

Jan 21, 2026NCENew Chemical Entity (5y)
Jan 21, 2026NCENew Chemical Entity (5y)
Jan 21, 2026NCENew Chemical Entity (5y)

Data sources

ClinicalTrials.gov

last refreshed 1h ago

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no comments yet — first sniff?

🐶 often sniffed alongside

top 8

tagApproval22 co-mentions · 11 sources
drugcabotegravir + rilpivirine LA13 co-mentions · 13 sources
tagInfectious Disease6 co-mentions · 6 sources
companyViiV Healthcare Company4 co-mentions · 4 sources
companyViiV Healthcare UK Ltd4 co-mentions · 4 sources
company$GLAXFGSK plc2 co-mentions · 2 sources
company$GSKGSK plc2 co-mentions · 2 sources
drugcabotegravir sodium2 co-mentions · 2 sources

Trials studying cabotegravir LA

phase1Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participantscompletedn=138
—Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Preventionrecruitingn=3,000
phase3Study 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 Participantsactive not recruitingn=631
phase3Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Mencompletedn=4,570
phase4Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugsrecruitingn=100
phase2A 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)active not recruitingn=185
phase3A 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 Therapyactive not recruitingn=171
phase4Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswanaactive not recruitingn=500

more trials →