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Profile for Tradename: PREZISTA

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Prezista is a drug marketed by Janssen Prods and is included in two NDAs. It is available from four suppliers. There are eleven patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in PREZISTA is darunavir ethanolate. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the darunavir ethanolate profile page.

Summary for Tradename: PREZISTA

Patents:11
Applicants:1
NDAs:2
Suppliers: see list4
2013 Sales:$992,087,000

Pharmacology for Tradename: PREZISTA

Clinical Trials for: PREZISTA

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

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

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

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

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

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

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

Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue
Status: Completed Condition: HIV/AIDS; HIV Infections

Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects
Status: Completed 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
TABLET;ORAL021976Jun 23, 2006DISCNNo<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Oct 21, 2008DISCNNo<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Jun 23, 2006DISCNNo7,700,645*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Jun 23, 2006DISCNNoRE43802*PED<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Nov 9, 2012RXYes<disabled><disabled>
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Paragraph IV activity for: PREZISTA

Drugname Dosage Strength RLD Submissiondate
darunavir ethanolateTablets75 mg, 150 mg, 300 mg, 400 mg and 600 mgPrezistas6/23/2010
darunavir ethanolateTablets800 mgPrezista5/14/2013
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