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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. Five 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 list5
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: dutasteride; tamsulosin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anchen Pharms
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509-001Feb 26, 2014RXNo► subscribe► subscribe
Actavis Labs Fl Inc
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202975-001Nov 20, 2015RXNo► subscribe► subscribe
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 2010RXYes5,565,467► subscribeYY ► subscribe
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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► subscribe
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 20105,998,427► subscribe
Glaxosmithkline
JALYN
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL022460-001Jun 14, 20105,846,976► subscribe
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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► subscribe
5,817,818 Androstenones► subscribe
5,846,976 Androstenone derivative► 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 Ingredient: dutasteride; tamsulosin hydrochloride

Country Document Number Estimated Expiration
Hungary220060► subscribe
Czech Republic9600745► subscribe
Norway2003003► 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: DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C009/2005Ireland► subscribeSPC009/2005: 20060316, EXPIRES: 20170718
0122Netherlands► subscribe
/2003Austria► subscribePRODUCT 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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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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