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Profile for Tradename: ZELAPAR

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Zelapar is a drug marketed by Valeant Pharm Intl and is included in one NDA. It is available from one supplier. There are two patents protecting this drug.

This drug has sixty-five patent family members in thirty-three countries.

The generic ingredient in ZELAPAR is selegiline hydrochloride. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the selegiline hydrochloride profile page.

Summary for Tradename: ZELAPAR

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Clinical Trials for: ZELAPAR

Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease
Status: Completed Condition: Parkinson's Disease

Evaluation of Adhesion and Dermal Tolerability of EMSAM
Status: Completed Condition: Healthy

PK Comparison of 6mg and 12mg EMSAM in Elderly vs. Non-Elderly
Status: Completed Condition: Healthy

Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
Status: Completed Condition: Major Depressive Disorder

A Pilot Study Assessing EmSam in Bipolar Depression
Status: Terminated Condition: Bipolar Depression

Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists
Status: Completed Condition: Parkinson's Disease

A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
Status: Completed Condition: Cognitive Disorders; HIV Infections

A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers
Status: Completed Condition: Alzheimer Disease, Healthy Volunteer

Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1
Status: Completed Condition: Marijuana Abuse

Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
Status: Recruiting Condition: Parkinson's Disease; Erectile Dysfunction

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
Valeant Pharm Intl
ZELAPAR
selegiline hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021479-001Jun 14, 2006RXYes5,648,093<disabled>Y<disabled>
Valeant Pharm Intl
ZELAPAR
selegiline hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021479-001Jun 14, 2006RXYes6,423,342<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: ZELAPAR

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
5,558,880 Pharmaceutical and other dosage forms<disabled in preview>
5,120,549 United States Patent: 5120549   ( 1<disabled in preview>
5,330,764 Methods of preparing bulk delivery matrices by solid-state dissolution<disabled in preview>
5,330,763 Delivery matrices prepared by solid-state dissolution<disabled in preview>
5,215,756 Preparation of pharmaceutical and other matrix systems by solid-state dissolution<disabled in preview>
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International Patent Family for Tradename: ZELAPAR

Country Document Number Publication Date
Israel105553Jan 04, 1998
European Patent Office0494077Jul 08, 1992
European Patent Office0642334Aug 18, 1999
JapanH10506408Jun 23, 1998
Australia4884596Sep 18, 1996
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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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