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AVODART Drug Profile

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Avodart is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from five suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in thirty-nine countries.

The generic ingredient in AVODART is dutasteride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dutasteride profile page.

Summary for Tradename: AVODART

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

Pharmacology for Tradename: AVODART

Clinical Trials for: AVODART

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 2001RXYes5,565,467<disabled>YY <disabled>
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Expired Patents for Tradename: AVODART

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,565,467<disabled>
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,998,427<disabled>
Glaxosmithkline
AVODART
dutasteride
CAPSULE;ORAL021319-001Nov 20, 20015,846,976<disabled>
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Paragraph IV activity for: AVODART

Drugname Dosage Strength RLD Submissiondate
dutasterideCapsules0.5 mgAvodart10/29/2007

Non-Orange Book Patents for Tradename: AVODART

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
5,817,818 Androstenones<disabled in preview>
5,977,126 Androstenones<disabled in preview>
5,846,976 Androstenone derivative<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: AVODART

Country Document Number Estimated Expiration
Germany10399022<disabled in preview>
Poland313492<disabled in preview>
South Africa9407118<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: AVODART

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00122Netherlands<disabled>PRODUCT NAME: DUTASTERIDUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 28317RVG 28318 2002161216; FIRST REGISTRATION: 1787117872 2002190719
0122Netherlands<disabled>
/2003Austria<disabled>PRODUCT NAME: DUTASTERIDE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SOLVATES; NAT. REGISTRATION NO/DATE: 1-24844, 1-24845 20030217; FIRST REGISTRATION: SE 17871, 17872 20020719
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