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FDA Orange Book · active-ingredient family

Imatinib mesylate

Imatinib mesylate is approved as 3 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:IMKELDI · NDA 219097

3

Brand (NDA)

16

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution, tablet

ProductApplicantApplicationTEApproved
IMKELDIRLDSHORLA ONCOLOGYNDA 219097—Nov 22, 2024
GLEEVECRLD×2NOVARTISNDA 021588ABApr 18, 2003
GLEEVECRLD×2NOVARTISNDA 021335—May 10, 2001

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
IMATINIB MESYLATE×2CSPC OUYIANDA 212193ABApr 21, 2025
IMATINIB MESYLATE×2HETERO LABS LTD VANDA 212975ABApr 14, 2025
IMATINIB MESYLATE×2QILU PHARM HAINANANDA 212135ABJun 21, 2022
IMATINIB MESYLATE×2EUGIA PHARMAANDA 212773ABJul 23, 2020
IMATINIB MESYLATE×2ZYDUS PHARMSANDA 210658ABApr 08, 2020
IMATINIB MESYLATE×2NATCO PHARMA LTDANDA 207818ABMar 01, 2019
IMATINIB MESYLATE×2AMNEAL PHARMSANDA 207495—Feb 08, 2019
IMATINIB MESYLATE×2NOVITIUM PHARMAANDA 205990—Feb 08, 2019
IMATINIB MESYLATE×2CHARTWELL RXANDA 208429ABJan 17, 2019
IMATINIB MESYLATE×2SHILPAANDA 208302ABJan 17, 2019
IMATINIB MESYLATE×2DR REDDYSANDA 206547ABAug 13, 2018
IMATINIB MESYLATE×2HIKMAANDA 207586—Jul 13, 2018
IMATINIB MESYLATE×2MYLANANDA 204644ABJun 21, 2017
IMATINIB MESYLATE×2APOTEXANDA 079179ABAug 05, 2016
IMATINIB MESYLATE×2TEVA PHARMS USAANDA 204285ABAug 04, 2016
IMATINIB MESYLATE×2SUN PHARMANDA 078340—Dec 03, 2015

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11957681Apr 27, 2040in 14 yr 1 mo
Product

Imatinib mesylate — frequently asked questions

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

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