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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Healthtrust
Cipla
McKinsey
US Department of Justice
Citi
Julphar
Accenture
Covington
Colorcon

Generated: October 20, 2017

DrugPatentWatch Database Preview

AZILECT Drug Profile

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What is the patent landscape for Azilect, and what generic Azilect 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 sixteen 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. Six suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.

Summary for Tradename: AZILECT

US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list55
Clinical Trials: see list24
Patent Applications: see list129
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AZILECT at DailyMed

Pharmacology for Tradename: AZILECT

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-002May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;ORAL021641-001May 16, 2006► Subscribe► Subscribe
Teva
AZILECT
rasagiline mesylate
TABLET;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
5,576,353 Method of treating memory disorders using R-enantiomers of N-propargyl-aminoindan compounds► Subscribe
7,619,117Rasagiline formulations and processes for their preparation► Subscribe
6,956,060 Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof► Subscribe
5,387,612 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
7,598,420Rasagiline formulations and processes for their preparation► Subscribe
5,786,390 Pharmaceutical compositions of the R-enantiomer of N-propargyl -1-aminoindan► Subscribe
5,519,061 R-enantiomer of n-propargyl-1-aminoindan, salts, compositions and uses thereof► Subscribe
6,630,514 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
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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
China1191481► Subscribe
Portugal858328► Subscribe
HungaryT77934► Subscribe
Australia6942796► Subscribe
Canada2232310► Subscribe
China101123946► Subscribe
JapanH11512736► Subscribe
Slovakia283675► Subscribe
Norway20074823► Subscribe
Spain2235170► 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
C0033France► SubscribePRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221
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
2005 00039Denmark► Subscribe
0812190/01Switzerland► SubscribeFORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL
0205Netherlands► Subscribe300205, 20141012, EXPIRES: 20191011
191Luxembourg► Subscribe91191, EXPIRES: 20191012
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
2005 00040Denmark► Subscribe
/2005Austria► SubscribePRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
Novartis
McKinsey
Cipla
Chubb
AstraZeneca
QuintilesIMS
Farmers Insurance
Fuji
Dow

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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