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Details for Generic Name: darunavir ethanolate

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Darunavir ethanolate is the generic ingredient in one branded drug marketed by Janssen Prods and is included in two NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for darunavir ethanolate. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: darunavir ethanolate

Drug Master File Entries: see list12
Suppliers / Packaging: see list11
Therapeutic Class:Antivirals

Pharmacology for Ingredient: darunavir ethanolate

Tentative approvals for DARUNAVIR ETHANOLATE

Applicant Application No. Form Dosage

Clinical Trials for: darunavir ethanolate

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

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

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

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

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

Courtesy of
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
darunavir ethanolate
SUSPENSION;ORAL202895-001Dec 16, 2011RXYesRE43802*PED<disabled> <disabled>
Janssen Prods
darunavir ethanolate
TABLET;ORAL021976-005Dec 18, 2008RXNo8,597,876*PED<disabled>Y<disabled>
Janssen Prods
darunavir ethanolate
SUSPENSION;ORAL202895-001Dec 16, 2011RXYes7,470,506*PED<disabled>Y<disabled>
Janssen Prods
darunavir ethanolate
TABLET;ORAL021976-004Dec 18, 2008RXNo<disabled><disabled>
Janssen Prods
darunavir ethanolate
TABLET;ORAL021976-003Oct 21, 2008DISCNNo<disabled><disabled>
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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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