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Serving leading biopharmaceutical companies globally:

Fuji
Cerilliant
Medtronic
Federal Trade Commission
Boehringer Ingelheim
Moodys
Covington
Cantor Fitzgerald
Julphar
McKesson

Generated: January 22, 2018

DrugPatentWatch Database Preview

Rasagiline mesylate - Generic Drug Details

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What are the generic drug sources for rasagiline mesylate and what is the scope of rasagiline mesylate freedom to operate?

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

Rasagiline mesylate has one hundred and seventeen patent family members in thirty-four countries.

There are eighteen drug master file entries for rasagiline mesylate. Seven suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for rasagiline mesylate
Pharmacology for rasagiline mesylate
Tentative approvals for RASAGILINE MESYLATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe0.5MGTABLET;ORAL
➤ Subscribe➤ Subscribe1MGTABLET;ORAL
➤ Subscribe➤ SubscribeEQ 1MG BASETABLET;ORAL

US Patents and Regulatory Information for rasagiline mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201823-002 Jul 1, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Pharms Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201971-001 May 15, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orchid Hlthcare RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201970-002 Mar 15, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Apotex Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201950-002 Sep 12, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201823-001 Jul 1, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for rasagiline mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 ➤ Subscribe ➤ Subscribe
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
5,891,923 R-enantiomer of N-propargyl-1-aminoindan for the treatment of dementia ➤ Subscribe
5,744,500 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof ➤ Subscribe
7,598,420 Rasagiline formulations and processes for their preparation ➤ Subscribe
6,956,060 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof ➤ Subscribe
5,576,353 Method of treating memory disorders using R-enantiomers of N-propargyl-aminoindan compounds ➤ Subscribe
5,519,061 R-enantiomer of n-propargyl-1-aminoindan, salts, compositions and uses thereof ➤ Subscribe
5,668,181 Use of the R-enantiomers of N-propargyl-1-aminoindan compounds for the treatment of depression ➤ Subscribe
6,316,504 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof ➤ Subscribe
5,532,415 R-enantiomer of N-propargyl-1-aminoindan, salts, compositions and uses thereof ➤ Subscribe
7,619,117 Rasagiline formulations and processes for their preparation ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for rasagiline mesylate

Supplementary Protection Certificates for rasagiline mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00205 Netherlands ➤ Subscribe PRODUCT 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
0205 Netherlands ➤ Subscribe 300205, 20141012, EXPIRES: 20191011
191 Luxembourg ➤ Subscribe 91191, EXPIRES: 20191012
0812190/01 Switzerland ➤ Subscribe FORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL
2005 00039 Denmark ➤ Subscribe
195 Luxembourg ➤ Subscribe 91195, EXPIRES: 20160102
C/GB05/042 United Kingdom ➤ Subscribe 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 Austria ➤ Subscribe PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
2005 00040 Denmark ➤ Subscribe
C024/2005 Ireland ➤ Subscribe SPC024/2005, 20060725, EXPIRES: 20191011
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
McKesson
AstraZeneca
US Department of Justice
Johnson and Johnson
Baxter
Novartis
Federal Trade Commission

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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