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Last Updated: November 22, 2024

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, Aurobindo Pharma Usa, Chartwell Rx, Indoco, Macleods Pharms Ltd, Micro Labs, Orbion Pharms, Ryan Labs, Skg Pharma, and Watson Labs Inc, and is included in twelve 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-six patent family members in eighteen countries.

There are eighteen drug master file entries for rasagiline mesylate. Twelve 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
Teva Branded Pharmaceutical Products R&D, Inc.Phase 4

See all RASAGILINE MESYLATE clinical trials

Generic filers with tentative approvals for RASAGILINE MESYLATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 1MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 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
Anatomical Therapeutic Chemical (ATC) Classes for RASAGILINE MESYLATE
Paragraph IV (Patent) Challenges for RASAGILINE MESYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AZILECT Tablets rasagiline mesylate 0.5 mg and 1 mg 021641 5 2010-05-17

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
Chartwell Rx RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 201892-001 Jul 27, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 207004-001 Mar 29, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs RASAGILINE MESYLATE rasagiline mesylate TABLET;ORAL 207004-002 Mar 29, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva AZILECT rasagiline mesylate TABLET;ORAL 021641-002 May 16, 2006 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up 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

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

International Patents for RASAGILINE MESYLATE

Country Patent Number Title Estimated Expiration
Russian Federation 2007135169 КОМПОЗИЦИИ РАЗАГИЛИНА С УЛУЧШЕННОЙ ОДНОРОДНОСТЬЮ ⤷  Sign Up
New Zealand 560660 Rasagiline ( R(+)-N-propargyl-1-aminodan ) formulations of improved content uniformity ⤷  Sign Up
Norway 20074823 ⤷  Sign Up
Iceland 8669 Rasagilínlyfjablöndur sem einsleitni innihaldsefna hefur verið endurbætt í ⤷  Sign Up
>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 ⤷  Sign Up PRODUCT NAME: RASAGILINE; REGISTRATION NO/DATE: EU/1/04/304/001-007 20050221
0812190 SPC/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
0812190 C300205 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
0812190 05C0033 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.