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Generic Name: darunavir ethanolate

Summary for Generic Name: darunavir ethanolate

Tradenames:1
Patents:10
Applicants:1
NDAs:2
Drug Master File Entries: see list7
Suppliers: see list4
Therapeutic Class:Antivirals

Clinical Trials for: darunavir ethanolate

A Study to Assess the Pharmacokinetics (Blood Levels) of TMC114 (Darunavir) Taken With Ritonavir and/or TMC125 (Etravirine) and TMC278 (Rilpivirine) in HIV-1 Infected Pregnant Women
Status: Recruiting Condition: HIV; HIV Infections; Pregnancy

TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
Status: Completed Condition: HIV Infections

An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients
Status: Completed Condition: Human Immunodeficiency Virus (HIV)

Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects
Status: Completed Condition: HIV Infections

TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Adults Coming From Any of the Three Ongoing Tibotec-Sponsored Studies With DRV
Status: Active, not recruiting Condition: HIV-1 Infections

Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults
Status: Active, not recruiting Condition: Acquired Immunodeficiency Syndrome; HIV Infections

DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects
Status: Recruiting Condition: HIV

Darunavir/Ritonavir and Rosuvastatin Pharmacokinetic Study
Status: Active, not recruiting Condition: HIV Infections

A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
Status: Completed Condition: Healthy Participants

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
Status: Active, not recruiting Condition: Hyperlipidemia; HIV

Courtesy of ClinicalTrials.org
See more clinical trials for this drug

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Product Substance Delist_Flag Patent Expiration Patented / Exclusive Use
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET; ORAL021976Nov 9, 2012RXYes<disabled>UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET; ORAL021976Nov 9, 2012RXYes<disabled>PEDIATRIC EXCLUSIVITY
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET; ORAL021976Nov 9, 2012RXYes<disabled>NEW PATIENT POPULATION
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET; ORAL021976Nov 9, 2012RXYes<disabled>800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1 INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
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