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Generic Name: darunavir ethanolate

Summary for Generic Name: darunavir ethanolate

Tradenames:1
Patents:11
Applicants:1
NDAs:2
Drug Master File Entries: see list11
Suppliers: see list4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: darunavir ethanolate

Tentative approvals for DARUNAVIR ETHANOLATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL75MG
<disabled><disabled>TABLET;ORAL150MG
<disabled><disabled>TABLET;ORAL400MG

Clinical Trials for: darunavir ethanolate

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

A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir/Ritonavir, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women
Status: Recruiting Condition: HIV; HIV Infections; Pregnancy

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

A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials
Status: Completed Condition: HIV

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin
Status: Completed Condition: HIV Infections; Hyperlipidemia

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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
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>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>800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1 INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
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