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Dutasteride; tamsulosin hydrochloride - Generic Drug Details

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Dutasteride; tamsulosin hydrochloride is the generic ingredient in two branded drugs marketed by Anchen Pharms, Glaxosmithkline, and Actavis Labs Fl Inc, and is included in three 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; tamsulosin hydrochloride. Four suppliers are listed for this compound.

Summary for Generic Name: dutasteride; tamsulosin hydrochloride

Tradenames:2
Patents:1
Applicants:3
NDAs:3
Drug Master File Entries: see list17
Suppliers / Packaging: see list4
Formulation / Manufacturing:see details

Pharmacology for Ingredient: dutasteride; tamsulosin hydrochloride

Clinical Trials for: dutasteride; tamsulosin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 2010RXYes5,565,467<disabled>YY <disabled>
Actavis Labs Fl Inc
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202975-001Nov 20, 2015RXNo<disabled><disabled>
Anchen Pharms
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509-001Feb 26, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: dutasteride; tamsulosin hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 20105,565,467<disabled>
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 20105,998,427<disabled>
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 20105,846,976<disabled>
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Non-Orange Book Patents for Generic Ingredient: dutasteride; tamsulosin hydrochloride

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; tamsulosin hydrochloride

Country Document Number Estimated Expiration
Iceland4205<disabled in preview>
Netherlands300122<disabled in preview>
South Korea100364953<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; TAMSULOSIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
C0030France<disabled>PRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
C009/2005Ireland<disabled>SPC009/2005: 20060316, EXPIRES: 20170718
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