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Last Updated: July 5, 2020

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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-seven 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 ANDA Litigation and Generic Entry Outlook for Azilect

A generic version of AZILECT was approved as rasagiline mesylate by ORCHID HLTHCARE on March 15th, 2016.

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Drug patent expirations by year for AZILECT
Drug Prices for AZILECT

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Recent Clinical Trials for AZILECT

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SponsorPhase
University of FloridaPhase 2
National Institute of Neurological Disorders and Stroke (NINDS)Phase 2
Thomas GuttusoN/A

See all AZILECT clinical trials

Pharmacology for AZILECT

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   Start Trial   Start Trial Y Y   Start Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AZILECT

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

Supplementary Protection Certificates for AZILECT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0812190 31/2005 Austria   Start Trial PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0812190 91191 Luxembourg   Start Trial 91191, EXPIRES: 20191012
0436492 CA 2005 00040 Denmark   Start Trial
0812190 CA 2005 00039 Denmark   Start Trial
0812190 C00812190/01 Switzerland   Start Trial FORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL
0812190 C300205 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
AstraZeneca
Colorcon
Johnson and Johnson
Baxter

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