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Last Updated: December 5, 2022

Rasagiline mesylate - Generic Drug Details


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What are the generic drug sources for rasagiline mesylate and what is the scope of patent protection?

Rasagiline mesylate is the generic ingredient in two branded drugs marketed by Teva, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Usa, Dr Reddys, Indoco, Micro Labs, Orbion Pharms, Sandoz Inc, and Watson Labs Inc, and is included in ten NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Rasagiline mesylate has twenty-seven patent family members in eighteen countries.

There are eighteen drug master file entries for rasagiline mesylate. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for rasagiline mesylate
Drug Prices for rasagiline mesylate

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Recent Clinical Trials for rasagiline mesylate

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

SponsorPhase
Teva Pharmaceutical IndustriesPhase 1
Teva Branded Pharmaceutical Products R&D, Inc.Phase 1
Technische Universität DresdenPhase 4

See all rasagiline mesylate clinical trials

Generic filers with tentative approvals for RASAGILINE MESYLATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 1MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 0.5MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for rasagiline mesylate

US Patents and Regulatory Information for rasagiline mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Usa RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201971-002 May 15, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201942-001 Nov 18, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201889-002 Oct 30, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201823-001 Jul 1, 2013 DISCN No No See Plans and Pricing See Plans and Pricing 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 rasagiline mesylate

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

International Patents for rasagiline mesylate

Country Patent Number Title Estimated Expiration
South Africa 200707469 Rasagiline formulations of improved content uniformity See Plans and Pricing
South Korea 20070111534 RASAGILINE FORMULATIONS OF IMPROVED CONTENT UNIFORMITY See Plans and Pricing
Russian Federation 2404746 КОМПОЗИЦИИ РАЗАГИЛИНА С УЛУЧШЕННОЙ ОДНОРОДНОСТЬЮ СОДЕРЖИМОГО (COMPOSITIONS OF RASAGILINE WITH IMPROVED HOMOGENEITY OF CONTENT) See Plans and Pricing
Norway 20074823 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for rasagiline mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0812190 31/2005 Austria See Plans and Pricing PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0812190 SPC/GB05/042 United Kingdom See Plans and Pricing 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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Harvard Business School

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