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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: see list4
2013 Sales:$992,087,000

Pharmacology for Tradename: PREZISTA

Clinical Trials for: PREZISTA

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
TABLET;ORAL021976Dec 18, 2008RXNoRE42889*PED<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Oct 21, 2008DISCNNo<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Feb 25, 2008RXNo6,703,403*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895Dec 16, 2011RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976Dec 18, 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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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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