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Details for Generic Name: dutasteride; tamsulosin hydrochloride

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Dutasteride; tamsulosin hydrochloride is the generic ingredient in two branded drugs marketed by Anchen Pharms and Glaxosmithkline, and is included in two 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 eigthy-one patent family members in thirty-eight countries.

There are fifteen drug master file entries for dutasteride; tamsulosin hydrochloride. Two suppliers are listed for this compound.

Summary for Generic Name: dutasteride; tamsulosin hydrochloride

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list15
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>
Anchen Pharms
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
dutasteride; tamsulosin hydrochloride
CAPSULE;ORAL202509-001Feb 26, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: dutasteride; tamsulosin hydrochloride

Country Document Number Publication Date
HungaryT74445Dec 30, 1996
Iceland4205Mar 18, 1995
Romania117455Mar 29, 2002
Israel110978Jan 26, 1999
Japan2904310Jun 14, 1999
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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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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