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Dutasteride - Generic Drug Details

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Dutasteride is the generic ingredient in four branded drugs marketed by Roxane, Breckenridge Pharm, Actavis Labs Fl Inc, Amneal Pharms, Glaxosmithkline, Vintage Pharms Llc, Rising Pharms Inc, Mylan Pharms Inc, Aurolife Pharma Llc, Strides Pharma, Intergel Pharms Inc, Apotex Inc, Barr, Bionpharma Inc, and Anchen Pharms, and is included in seventeen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are seventeen drug master file entries for dutasteride. Eighteen suppliers are listed for this compound.

Summary for Generic Name: dutasteride

Tradenames:4
Patents:1
Applicants:15
NDAs:17
Drug Master File Entries: see list17
Suppliers / Packaging: see list18
Therapeutic Class:Genitourinary Agents
Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: dutasteride

Clinical Trials for: dutasteride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bionpharma Inc
DUTASTERIDE
dutasteride
CAPSULE;ORAL200899-001Nov 20, 2015RXNo<disabled><disabled>
Vintage Pharms Llc
DUTASTERIDE
dutasteride
CAPSULE;ORAL202421-001Nov 20, 2015RXNo<disabled><disabled>
Roxane
DUTASTERIDE
dutasteride
CAPSULE;ORAL202204-001Nov 23, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: dutasteride

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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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Non-Orange Book Patents for Generic Ingredient: dutasteride

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
5,977,126 Androstenones<disabled in preview>
5,817,818 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 Ingredient: dutasteride

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: DUTASTERIDE

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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