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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 eleven 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

Tradenames:1
Patents:11
Applicants:1
NDAs:2
Drug Master File Entries: see list11
Suppliers / Packaging: see list11
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for Ingredient: darunavir ethanolate

Tentative approvals for DARUNAVIR ETHANOLATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL600MG
<disabled><disabled>TABLET;ORAL150MG
<disabled><disabled>TABLET;ORAL300MG

Clinical Trials for: darunavir ethanolate

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, 2008DISCNNo5,843,946*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895-001Dec 16, 2011RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 2006DISCNNo5,843,946*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 2008RXNo7,700,645*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895-001Dec 16, 2011RXYesRE43596*PED<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

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

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