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Profile for Tradename: AZILECT

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Azilect is a drug marketed by Teva and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nine patent family members in thirty-four countries.

The generic ingredient in AZILECT is rasagiline mesylate. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the rasagiline mesylate profile page.

Summary for Tradename: AZILECT

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list5

Pharmacology for Tradename: AZILECT

Clinical Trials for: AZILECT

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline
Status: Completed Condition: Parkinson's Disease

Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
Status: Completed Condition: Parkinson's Disease

Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease
Status: Completed Condition: Parkinson's Disease

Azilect + Antidepressant Chart Review
Status: Completed Condition: Serotonin Syndrome

A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease
Status: Completed Condition: Parkinson's Disease

Azilect® In Wearing-Off (AIWO)
Status: Completed Condition: Parkinson's Disease

Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea
Status: Completed Condition: Parkinson's Disease

Effects of Rasagiline on Sleep Disturbances in Parkinson's Disease
Status: Not yet recruiting Condition: Sleep Disturbances; Parkinsons's Disease

Emotion, Mood and Executive Function in Parkinson`s Disease (PD)
Status: Not yet recruiting Condition: Parkinson Disease

A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's Patients
Status: Active, not recruiting Condition: Parkinson's Disease

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
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006RXNo5,453,446<disabled><disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYes7,815,942<disabled>YY<disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006RXNo7,572,834<disabled>Y<disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYes7,572,834<disabled>Y<disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006RXNo7,815,942<disabled>YY<disabled>
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Paragraph IV activity for: AZILECT

Drugname Dosage Strength RLD Submissiondate
rasagiline mesylateTablets0.5 mg and 1 mgAzilect5/17/2010

International Patent Family for Tradename: AZILECT

Country Document Number Publication Date
European Patent Office0812190Dec 17, 1997
Canada2221458Nov 28, 1996
Latvia12083Sep 20, 1998
Portugal812190Apr 29, 2005
Mexico9708977Mar 31, 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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