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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 ten 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 are three tentative approvals for this compound.

Summary for Generic Name: rasagiline mesylate

Tradenames:2
Patents:4
Applicants:3
NDAs:3
Drug Master File Entries: see list17
Suppliers / Packaging: see list5
Therapeutic Class:Antiparkinson Agents

Pharmacology for Ingredient: rasagiline mesylate

Tentative approvals for RASAGILINE MESYLATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL0.5MG
<disabled><disabled>TABLET;ORAL1MG
<disabled><disabled>TABLET;ORALEQ 0.5MG BASE

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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs Inc
RASAGILINE MESYLATE
rasagiline mesylate
TABLET;ORAL201823-002Jul 1, 2013DISCNNo<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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Expired Orange Book Patents for Generic Ingredient: rasagiline mesylate

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 20065,532,415<disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 20065,457,133<disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,387,612<disabled>
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International Patent Family for Ingredient: rasagiline mesylate

Country Document Number Publication Date
MexicoPA94008019Aug 10, 2004
South Africa9408013May 31, 1995
Hungary9601012Jun 28, 1996
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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