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Last Updated: August 15, 2020

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RASAGILINE MESYLATE - Generic Drug Details

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What are the generic drug sources for rasagiline mesylate and what is the scope of freedom to operate?

Rasagiline mesylate is the generic ingredient in two branded drugs marketed by Teva, Alkem Labs Ltd, Apotex Inc, Indoco Remedies, Micro Labs, Mylan, Orchid Hlthcare, Sandoz Inc, and Watson Labs Inc, and is included in nine 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. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

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 Pharmaceutical IndustriesPhase 4
Technische Universität DresdenPhase 4

See all RASAGILINE MESYLATE clinical trials

Generic filers with tentative approvals for RASAGILINE MESYLATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 1MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 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
Sandoz Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201892-002 Jul 27, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201971-001 May 15, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201823-002 Jul 1, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-001 May 16, 2006 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Orchid Hlthcare RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201970-002 Mar 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201889-001 Oct 30, 2017 AB RX No No   Start Trial   Start Trial   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 RASAGILINE MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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
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 RASAGILINE MESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0812190 SPC/GB05/042 United Kingdom   Start Trial 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 31/2005 Austria   Start Trial PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
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
0812190 05C0033 France   Start Trial 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:

Boehringer Ingelheim
Colorcon
Harvard Business School
Express Scripts
McKinsey
Merck

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