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FDA Orange Book · active-ingredient family

Rasagiline mesylate

Rasagiline mesylate is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AZILECT · NDA 021641

1

Brand (NDA)

12

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
AZILECTRLD×2TEVANDA 021641ABMay 16, 2006

Generic (ANDA) products (12)

ProductApplicantApplicationTEApproved
RASAGILINE MESYLATE×2TORRENTANDA 210150ABMay 05, 2025
RASAGILINE MESYLATE×2MACLEODS PHARMS LTDANDA 208866ABJun 28, 2024
RASAGILINE MESYLATE×2RISINGANDA 218163ABApr 09, 2024
RASAGILINE MESYLATE×2CARNEGIEANDA 201942ABNov 18, 2021
RASAGILINE MESYLATE×2REGCON HOLDINGSANDA 206153ABOct 04, 2019
RASAGILINE MESYLATE×2MICRO LABSANDA 207004ABMar 29, 2019
RASAGILINE MESYLATE×2CHARTWELL RXANDA 201892ABJul 27, 2018
RASAGILINE MESYLATE×2ALKEM LABS LTDANDA 201889ABOct 30, 2017
RASAGILINE MESYLATE×2AUROBINDO PHARMA USAANDA 201971ABMay 15, 2017
RASAGILINE MESYLATE×2ORBION PHARMSANDA 201970ABMar 15, 2016
RASAGILINE MESYLATE×2APOTEX INCANDA 201950—Sep 12, 2013
RASAGILINE MESYLATE×2WATSON LABS INCANDA 201823—Jul 01, 2013

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7572834Dec 05, 2026in 6 mo
Product
7815942Aug 27, 2027in 1 yr 2 mo
SubstanceProductU-219

Rasagiline mesylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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