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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Dow
Covington
McKinsey
McKesson
Express Scripts
Accenture
Colorcon
Moodys

Generated: May 26, 2018

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 two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in eighteen countries.

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

US Patents and Regulatory Information for 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;ORAL 021641-001 May 16, 2006 AB RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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 AZILECT

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

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Paragraph IV (Patent) Challenges for AZILECT
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 0.5 mg and 1 mg ➤ Subscribe 2010-05-17

Non-Orange Book US Patents for 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
7,598,420 Rasagiline formulations and processes for their preparation ➤ Sign Up
7,619,117 Rasagiline formulations and processes for their preparation ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for AZILECT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2005 Austria ➤ Sign Up PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
C0033 France ➤ Sign Up PRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221
00205 Netherlands ➤ Sign Up 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
C/GB05/042 United Kingdom ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cipla
Fuji
Dow
Federal Trade Commission
Argus Health
Cerilliant
Medtronic
Farmers Insurance

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