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Last Updated: September 25, 2022

AZILECT Drug Patent 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.

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. Nine suppliers are listed for this compound. Additional details are available on the rasagiline mesylate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Azilect

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

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Summary for AZILECT
Drug patent expirations by year for AZILECT
Drug Prices for AZILECT

See drug prices for AZILECT

Recent Clinical Trials for AZILECT

Identify potential brand extensions & 505(b)(2) entrants

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

See all AZILECT clinical trials

Pharmacology for AZILECT
Anatomical Therapeutic Chemical (ATC) Classes for AZILECT

US Patents and Regulatory Information for AZILECT

AZILECT is protected by two US patents.

Patents protecting AZILECT

Rasagiline formulations and processes for their preparation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Rasagiline formulations of improved content uniformity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

International Patents for AZILECT

See the table below for patents covering AZILECT around the world.

Country Patent Number Title Estimated Expiration
Japan 2987453 See Plans and Pricing
Norway 975331 See Plans and Pricing
Spain 2586412 See Plans and Pricing
South Korea 20070111534 RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY See Plans and Pricing
Germany 69434178 See Plans and Pricing
Israel 92952 See Plans and Pricing
Israel 118247 USE OF R-ENANTIOMER OF N-PROPARGYL-1-AMINOINDAN AND SALTS THEREOF IN THE PREPARATION OF A MEDICAMENT FOR THE TREATMENT OF STROKE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AZILECT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0812190 C00812190/01 Switzerland See Plans and Pricing FORMER OWNER: TEVA PHARMACEUTICAL INDUSTRIES, LTD., IL
0812190 CA 2005 00039 Denmark See Plans and Pricing
0812190 05C0033 France See Plans and Pricing PRODUCT NAME: RASAGILINE; NAT. REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221; FIRST REGISTRATION: EU/1/4/304/001-007 20050221
0436492 CA 2005 00040 Denmark See Plans and Pricing
0812190 C300205 Netherlands See Plans and Pricing 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
0812190 31/2005 Austria See Plans and Pricing PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0812190 SPC024/2005 Ireland See Plans and Pricing SPC024/2005, 20060725, EXPIRES: 20191011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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AstraZeneca
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Johnson and Johnson
Baxter

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