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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 twenty-one 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
Drug Prices: :see details

Pharmacology for Tradename: 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► subscribe► subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-003Oct 21, 2008DISCNNo7,700,645*PED► subscribeY► subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 2006DISCNNoRE43802*PED► subscribe ► subscribe
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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
SUSPENSION;ORAL202895-001Dec 16, 20116,335,460*PED► subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-005Dec 18, 20086,335,460*PED► subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 20086,248,775*PED► subscribe
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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
6,417,387 .alpha.-and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors► subscribe
6,172,082 .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors► subscribe
6,248,775 .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors► subscribe
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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
Greece3029378► subscribe
Norway950533► subscribe
Hong Kong1053782► subscribe
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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
00283Netherlands► subscribePRODUCT NAME: DARUNAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER DARUNAVIR ETHANOLAAT; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
07/024Ireland► subscribe
2007 00017Denmark► subscribe
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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