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Profile for Tradename: JALYN

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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 eigthy-one patent family members in thirty-eight countries.

The generic ingredient in JALYN is dutasteride; tamsulosin hydrochloride. There are fifteen drug master file entries for this compound. Two 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 list4
Formulation / Manufacturing:see details

Clinical Trials for: JALYN

JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Status: Terminated Condition: Benign Prostatic Hyperplasia; Chronic Prostatitis

Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States
Status: Completed Condition: Prostatic Hyperplasia

A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.
Status: Completed Condition: Prostatic Hyperplasia

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
Status: Completed Condition: Urologic Diseases

Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males.
Status: Completed Condition: Prostatic Hyperplasia

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
Status: Recruiting Condition: Prostate Cancer

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State
Status: Completed Condition: Urologic Diseases

A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.
Status: Completed Condition: Benign Prostatic Hyperplasia

A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia
Status: Completed Condition: Prostatic Hyperplasia

A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
Status: Completed Condition: Benign Prostatic Hyperplasia

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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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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 Publication Date
Canada2449679Oct 23, 2007
Norway961085Apr 22, 1996
Germany69407978Feb 19, 1998
Russian Federation2140926Nov 10, 1999
Australia685167Jan 15, 1998
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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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