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Details for Generic Name: rasagiline mesylate

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Rasagiline mesylate is the generic ingredient in two branded drugs marketed by Teva, Apotex Inc, and Watson Labs Inc, and is included in three NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and eight patent family members in thirty-four countries.

There are seventeen drug master file entries for rasagiline mesylate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: rasagiline mesylate

Tradenames:2
Patents:4
Applicants:3
NDAs:3
Drug Master File Entries: see list17
Suppliers: see list2
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: rasagiline mesylate

Tentative approvals for RASAGILINE MESYLATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL0.5MG
<disabled><disabled>TABLET; ORAL1MG

Clinical Trials for: rasagiline mesylate

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

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

Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
Status: Completed Condition: Parkinson's Disease

ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects
Status: Completed Condition: Parkinson's Disease

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

Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)
Status: Completed Condition: Multiple System Atrophy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
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;ORAL021641-002May 16, 2006RXYes<disabled><disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYes7,815,942<disabled>YY<disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006RXNo<disabled><disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYes5,453,446<disabled><disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006RXNo7,815,942<disabled>YY<disabled>
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International Patent Family for Ingredient: rasagiline mesylate

Country Document Number Publication Date
Denmark0436492Jul 11, 1994
Spain2235170Jul 01, 2005
Russian Federation2007135169Mar 27, 2009
Poland184124Sep 30, 2002
BrazilPI0608209Nov 09, 2010
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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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