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JALYN Drug Profile

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Jalyn is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from two 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 JALYN is dutasteride; tamsulosin hydrochloride. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dutasteride; tamsulosin hydrochloride profile page.

Summary for Tradename: JALYN

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details

Clinical Trials for: JALYN

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>
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Expired Patents for Tradename: JALYN

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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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Paragraph IV activity for: JALYN

Drugname Dosage Strength RLD Submissiondate
dutasteride and tamsulosin hydrochlorideCapsule0.5 mg/0.4 mgJalyn10/26/2010

Non-Orange Book Patents for Tradename: JALYN

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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International Patent Family for Tradename: JALYN

Country Document Number Estimated Expiration
Hungary9600656<disabled in preview>
Taiwan408127<disabled in preview>
Finland115216<disabled in preview>
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Supplementary Protection Certificates for Tradename: JALYN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2003 007, C 0719278 /LLithuania<disabled>
C009/2005Ireland<disabled>SPC009/2005: 20060316, EXPIRES: 20170718
C/GB03/018United Kingdom<disabled>PRODUCT NAME: DUTASTERIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SOLVATE.; REGISTERED: SE 17871 20020719; SE 17872 20020719; UK PL 19494/0005 20030117; UK PL 19494/0006 20030117
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