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Darunavir ethanolate - Generic Drug Details

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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 ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are fourteen drug master file entries for darunavir ethanolate. Five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: darunavir ethanolate

Tradenames:1
Patents:10
Applicants:1
NDAs:2
Drug Master File Entries: see list14
Suppliers / Packaging: see list5
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;ORAL75MG
<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, 2008DISCNNo7,700,645*PED<disabled>Y<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-006Nov 9, 2012RXYesRE42889*PED<disabled> <disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 2008RXNo7,700,645*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: darunavir ethanolate

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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, 20115,843,946*PED<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
SUSPENSION;ORAL202895-001Dec 16, 20116,248,775*PED<disabled>
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-001Jun 23, 20065,843,946*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: darunavir ethanolate

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
6,472,407 .alpha. and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors<disabled in preview>
6,248,775 .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors<disabled in preview>
6,646,010 .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 Ingredient: darunavir ethanolate

Country Document Number Estimated Expiration
Norway950533<disabled in preview>
European Patent Office0871465<disabled in preview>
Canada2224738<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: DARUNAVIR ETHANOLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00017Denmark<disabled>
07/024Ireland<disabled>
00283Netherlands<disabled>PRODUCT 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
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