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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 / Packagers: see list11
2013 Sales:$992,087,000

Pharmacology for Tradename: PREZISTA

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)

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

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

A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
Status: Recruiting Condition: Acquired Immune Deficiency Syndrome

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

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

Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
Status: Completed Condition: HIV

GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.
Status: Completed Condition: HIV; Infectious

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
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;ORAL021976-003Oct 21, 2008DISCNNo<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-006Nov 9, 2012RXYes5,843,946*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-005Dec 18, 2008RXNo5,843,946*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-005Dec 18, 2008RXNo8,597,876*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 2008RXNo5,843,946*PED<disabled>Y<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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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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