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Details for Generic Name: darunavir ethanolate

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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

Pharmacology for Ingredient: darunavir ethanolate

Tentative approvals for DARUNAVIR ETHANOLATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL150MG
<disabled><disabled>TABLET;ORAL300MG
<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

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

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

A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents
Status: Completed Condition: HIV-1; 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

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

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. Exclusivity Expiration
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895Dec 16, 2011RXYes8,518,987*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Nov 9, 2012RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895Dec 16, 2011RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Nov 9, 2012RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Feb 25, 2008RXNo<disabled><disabled>
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