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PREZISTA Drug Profile

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Prezista is a drug marketed by Janssen Prods and is included in two NDAs. It is available from five suppliers. There are ten patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-seven patent family members in twenty countries.

The generic ingredient in PREZISTA is darunavir ethanolate. There are fourteen drug master file entries for this compound. Five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the darunavir ethanolate profile page.

Summary for Tradename: PREZISTA

Patents:10
Applicants:1
NDAs:2
Suppliers / Packagers: see list5

Pharmacology for Tradename: PREZISTA

Clinical Trials for: PREZISTA

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;ORAL021976-006Nov 9, 2012RXYes<disabled><disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-003Oct 21, 2008DISCNNoRE42889*PED<disabled> <disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 2006DISCNNo6,703,403*PED<disabled>Y<disabled>
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Expired Patents for Tradename: PREZISTA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 20066,248,775*PED<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-003Oct 21, 20085,843,946*PED<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-004Dec 18, 20086,335,460*PED<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

Non-Orange Book Patents for Tradename: PREZISTA

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
6,500,832 .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors<disabled in preview>
5,968,942 .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors<disabled in preview>
6,472,407 .alpha. and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: PREZISTA

Country Document Number Estimated Expiration
Russian Federation95106624<disabled in preview>
World Intellectual Property Organization (WIPO)9701349<disabled in preview>
Denmark1293207<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PREZISTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00017Denmark<disabled>
90034-3Sweden<disabled>PRODUCT NAME: DARUNAVIR ELLER FARMACEUTISKT GODTAGBART SALT ELLER ESTER DAERAV; REGISTRATION NO/DATE: EU/1/06/380 20070212
07/024Ireland<disabled>
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