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Rasagiline mesylate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for rasagiline mesylate?

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 twelve patent family members in thirty-four countries.

There are eighteen drug master file entries for rasagiline mesylate. Five suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: rasagiline mesylate

Tradenames:2
Patents:5
Applicants:4
NDAs:4
Drug Master File Entries: see list18
Suppliers / Packagers: see list5
Bulk Api Vendors: see list55
Clinical Trials: see list196
Patent Applications: see list128
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:rasagiline mesylate at DailyMed

Pharmacology for Ingredient: rasagiline mesylate

Tentative approvals for RASAGILINE MESYLATE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;ORAL0.5MG
► Subscribe► SubscribeTABLET;ORAL1MG
► Subscribe► SubscribeTABLET;ORALEQ 0.5MG BASE
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orchid Hlthcare
RASAGILINE MESYLATE
rasagiline mesylate
TABLET;ORAL201970-001Mar 15, 2016RXNoNo► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYesYes► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYesYes7,572,834► SubscribeY ► Subscribe
Watson Labs Inc
RASAGILINE MESYLATE
rasagiline mesylate
TABLET;ORAL201823-001Jul 1, 2013RXNoNo► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006RXYesYes6,126,968► 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;ORAL021641-002May 16, 20065,453,446► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,387,612► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,532,415► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,786,390► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 20065,453,446► 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
5,744,500 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof► Subscribe
7,619,117Rasagiline formulations and processes for their preparation► Subscribe
6,316,504 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof► Subscribe
5,387,612 Use of the R-enantiomers of N-propargyl-1-aminoindan compounds for treating Parkinson's disease► Subscribe
5,457,133 R-enantiomers of N-propargyl-aminoindan compounds, their preparation and pharmaceutical compositions containing them► 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
Luxembourg91195► Subscribe
Estonia9700310► Subscribe
European Patent Office0828485► Subscribe
Germany122005000044► Subscribe
China1191481► 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
00205Netherlands► SubscribePRODUCT NAME: RASAGILINE, DESGEWENST IN DE VORM VAN EENFARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MESYLAAT; REGISTRATION NO/DATE: EU/1/04/304/001 T/M 007 20050221
195Luxembourg► Subscribe91195, EXPIRES: 20160102
/2005Austria► SubscribePRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0205Netherlands► Subscribe300205, 20141012, EXPIRES: 20191011
2005 00039Denmark► Subscribe
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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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