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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 eighteen 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 list18
Suppliers / Packaging: see list3
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
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, 2006RXNo7,815,942► subscribeYY ► subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006RXNo5,453,446► subscribe ► subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYes6,126,968► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: rasagiline mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,532,415► subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,387,612► subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 20065,786,390► subscribe
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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► subscribe
5,387,612 Use of the R-enantiomers of N-propargyl-1-aminoindan compounds for treating Parkinson's disease► subscribe
7,619,117Rasagiline formulations and processes for their preparation► subscribe
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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
Ireland62371► subscribe
Japan2000508292► subscribe
World Intellectual Property Organization (WIPO)9637199► subscribe
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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 00039Denmark► subscribe
191Luxembourg► subscribe91191, EXPIRES: 20191012
/2005Austria► subscribePRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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