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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Daiichi Sankyo
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Cipla
Fuji
Cantor Fitzgerald
Citi
Colorcon
Deloitte

Generated: December 15, 2017

DrugPatentWatch Database Preview

AZILECT Drug Profile

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When do Azilect patents expire, and what generic alternatives are available?

Azilect is a drug marketed by Teva and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventeen patent family members in thirty-four countries and eleven supplementary protection certificates in eight countries.

The generic ingredient in AZILECT is rasagiline mesylate. There are eighteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.
Drug patent expirations by year for AZILECT

Pharmacology for AZILECT

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: AZILECT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
TevaAZILECTrasagiline mesylateTABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for AZILECT

Drugname Dosage Strength RLD Submissiondate
rasagiline mesylateTablets0.5 mg and 1 mgAzilect5/17/2010

Non-Orange Book Patents for Tradename: AZILECT

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
5,668,181 Use of the R-enantiomers of N-propargyl-1-aminoindan compounds for the treatment of depression► Subscribe
7,619,117Rasagiline formulations and processes for their preparation► Subscribe
6,630,514 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
5,744,500 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof► Subscribe
6,956,060 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof► Subscribe
5,786,390 Pharmaceutical compositions of the R-enantiomer of N-propargyl -1-aminoindan► Subscribe
5,599,991 Esylate and sulfate salts of R(+)-N-propargyl-1-aminoindan► Subscribe
5,532,415 R-enantiomer of N-propargyl-1-aminoindan, salts, compositions and uses thereof► Subscribe
5,891,923 R-enantiomer of N-propargyl-1-aminoindan for the treatment of dementia► 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 Tradename: AZILECT

Country Document Number Estimated Expiration
Japan2987453► Subscribe
Japan2000508292► Subscribe
World Intellectual Property Organization (WIPO)9712583► Subscribe
JapanH11512736► Subscribe
Canada2221458► Subscribe
China1191481► Subscribe
Luxembourg91195► Subscribe
Canada2174449► Subscribe
Australia728524► Subscribe
Portugal812190► 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: AZILECT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2005Austria► SubscribePRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
C/GB05/042United Kingdom► SubscribePRODUCT 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
195Luxembourg► Subscribe91195, EXPIRES: 20160102
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
C0033France► SubscribePRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221
191Luxembourg► Subscribe91191, EXPIRES: 20191012
0205Netherlands► Subscribe300205, 20141012, EXPIRES: 20191011
C024/2005Ireland► SubscribeSPC024/2005, 20060725, EXPIRES: 20191011
0812190/01Switzerland► SubscribeFORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL
2005 00040Denmark► Subscribe
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Baxter
Merck
Boehringer Ingelheim
Covington
Deloitte
Cantor Fitzgerald
Farmers Insurance
Fuji
Cipla

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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