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Tradename: PREZISTA

Summary for Tradename: PREZISTA

Patents:11
Applicants:1
NDAs:2
Suppliers: see list4
2013 Sales:$992,087,000
drug
patent expirations by year for
 PREZISTA

Pharmacology for Tradename: PREZISTA

Drug ClassProtease Inhibitor
Mechanism of ActionHIV Protease Inhibitors

Clinical Trials for: PREZISTA

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

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

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

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

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

DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects
Status: Active, not recruiting Condition: HIV

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

Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue
Status: Completed Condition: HIV/AIDS; 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, 2011RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895Dec 16, 2011RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895Dec 16, 2011RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895Dec 16, 2011RXYes<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

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