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Profile for Tradename: NORVIR

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Norvir is a drug marketed by Abbott and Abbvie and is included in four NDAs. It is available from one supplier. There are fourteen patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in NORVIR is ritonavir. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ritonavir profile page.

Clinical Trials for: NORVIR

Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals
Status: Recruiting Condition: AIDS-related Dementia Complex

Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
Status: Completed Condition: Healthy

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

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

Bioequivalence Study of Generic GPO Saquinavir and Norvir® Versus Invirase® and Norvir®
Status: Withdrawn Condition: HIV Infections

PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
Status: Active, not recruiting Condition: HIV Infections

Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.
Status: Completed Condition: HIV; Cardiovascular Disease

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

A Phase 4 Study to Evaluate Pharmacokinetics and Safety of Darunavir Along With Ritonavir in Healthy Male Japanese Participants
Status: Completed Condition: Healthy

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
Abbott
NORVIR
ritonavir
CAPSULE;ORAL020680-001Mar 1, 1996DISCNNo5,648,497*PED<disabled>Y<disabled>
Abbvie
NORVIR
ritonavir
TABLET;ORAL022417-001Feb 10, 2010RXYes7,148,359*PED<disabled>Y<disabled>
Abbvie
NORVIR
ritonavir
CAPSULE;ORAL020945-001Jun 29, 1999RXYes6,037,157*PED<disabled>Y<disabled>
Abbvie
NORVIR
ritonavir
CAPSULE;ORAL020945-001Jun 29, 1999RXYes7,141,593*PED<disabled>Y<disabled>
Abbvie
NORVIR
ritonavir
SOLUTION;ORAL020659-001Mar 1, 1996RXYes5,484,801*PED<disabled><disabled>
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Paragraph IV activity for: NORVIR

Drugname Dosage Strength RLD Submissiondate
ritonavirCapsules100 mgNorvir10/31/2012
ritonavirTablets100 mgNorvir12/21/2010

Non-Orange Book Patents for Tradename: NORVIR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,597,927 Retroviral protease inhibiting compounds<disabled in preview>
5,892,052 Process for making retroviral protease inhibiting compounds<disabled in preview>
5,539,122 Retroviral protease inhibiting compounds<disabled in preview>
8,193,367Polymorph of a pharmaceutical<disabled in preview>
5,659,044 Retroviral protease inhibiting compounds<disabled in preview>
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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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