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Rasagiline mesylate - Generic Drug Details

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Rasagiline mesylate is the generic ingredient in two branded drugs marketed by Watson Labs Inc, Teva, Apotex Inc, and Orchid Hlthcare, and is included in four 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 eleven patent family members in thirty-four countries.

There are seventeen drug master file entries for rasagiline mesylate. Three 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:4
NDAs:4
Drug Master File Entries: see list17
Suppliers / Packaging: see list3
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
<disabled><disabled>TABLET;ORALEQ 0.5MG BASE

Clinical Trials for: rasagiline mesylate

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>
Apotex Inc
RASAGILINE MESYLATE
rasagiline mesylate
TABLET;ORAL201950-002Sep 12, 2013RXNo<disabled><disabled>
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYes5,453,446<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: rasagiline mesylate

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

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
5,576,353 Method of treating memory disorders using R-enantiomers of N-propargyl-aminoindan compounds<disabled in preview>
5,387,612 Use of the R-enantiomers of N-propargyl-1-aminoindan compounds for treating Parkinson's disease<disabled in preview>
5,744,500 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: rasagiline mesylate

Country Document Number Estimated Expiration
Israel244802<disabled in preview>
Israel184033<disabled in preview>
China1096853<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RASAGILINE MESYLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2005 00040Denmark<disabled>
C/GB05/042United Kingdom<disabled>PRODUCT NAME: MESYLATE, ESYLATE OR SULFATE SALTS OF N-PROPARGYL-1(R)-AMINOINDAN (RASAGILINE); REGISTERED: UK EU/1/04/304/001 20050221; UK EU/1/04/304/002 20050221; UK EU/1/04/304/003 20050221; UK EU/1/04/304/004 20050221; UK EU/1/04/304/005 20050221; UK EU/1/04/304/006 20050221; UK EU/1/04/304/007 20050221
2005 00039Denmark<disabled>
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