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FDA Orange Book · active-ingredient family

Esomeprazole magnesium

Esomeprazole magnesium is approved as 6 brand and 49 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ESOMEPRAZOLE MAGNESIUM · NDA 214278

6

Brand (NDA)

49

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, delayed rel pellets, capsule, delayed release, for suspension, delayed release, tablet, delayed release, tablet, orally disintegrating, delayed release

ProductApplicantApplicationTEApproved
ESOMEPRAZOLE MAGNESIUMRLDDEXCELNDA 214278—Oct 20, 2020
NEXIUM 24HRRLDASTRAZENECA LPNDA 207920—Nov 23, 2015
NEXIUM 24HRRLDASTRAZENECA LPNDA 204655—Mar 28, 2014
NEXIUMRLD×4ASTRAZENECANDA 021957ABDec 15, 2011
NEXIUMRLDASTRAZENECANDA 022101ABFeb 27, 2008
NEXIUMRLD×2ASTRAZENECANDA 021153ABFeb 20, 2001

Generic (ANDA) products (49)

ProductApplicantApplicationTEApproved
ESOMEPRAZOLE MAGNESIUM×3AUROBINDO PHARMA LTDANDA 218948ABApr 15, 2025
ESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMA LTDANDA 219213ABApr 15, 2025
ESOMEPRAZOLE MAGNESIUM×4TORRENTANDA 212651ABMar 05, 2025
ESOMEPRAZOLE MAGNESIUMTORRENTANDA 212652ABMar 05, 2025
ESOMEPRAZOLE MAGNESIUM×2CIPLAANDA 217714ABJan 07, 2025
ESOMEPRAZOLE MAGNESIUM×2MACLEODS PHARMS LTDANDA 208511—Oct 23, 2024
ESOMEPRAZOLE MAGNESIUMGLENMARK SPECLTANDA 218092—Jun 11, 2024
ESOMEPRAZOLE MAGNESIUMDR REDDYSANDA 207198—Apr 30, 2024
ESOMEPRAZOLE MAGNESIUM×2ZHEJIANG YONGTAIANDA 217022ABDec 27, 2023
ESOMEPRAZOLE MAGNESIUM×2GRANULESANDA 217427ABOct 18, 2023
ESOMEPRAZOLE MAGNESIUMMARKSANS PHARMAANDA 217264—Sep 29, 2023
ESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMA LTDANDA 214473—Jul 12, 2023
ESOMEPRAZOLE MAGNESIUM×2ZYDUS PHARMSANDA 206055ABJun 07, 2023
ESOMEPRAZOLE MAGNESIUM×2PRINSTON INCANDA 214920ABMar 28, 2023
ESOMEPRAZOLE MAGNESIUMGUARDIAN DRUGANDA 216149—Mar 15, 2023
ESOMEPRAZOLE MAGNESIUMGRAVITI PHARMSANDA 216349—Jun 24, 2022
ESOMEPRAZOLE MAGNESIUM×2ETHYPHARMANDA 090841ABMar 31, 2021
ESOMEPRAZOLE MAGNESIUM×2GRAVITI PHARMSANDA 213486ABMar 19, 2021
ESOMEPRAZOLE MAGNESIUM×2INDCHEMIE HEALTHANDA 210559ABFeb 26, 2021
ESOMEPRAZOLE MAGNESIUM×2GUANGZHOU NOVAKENANDA 213859ABNov 18, 2020
ESOMEPRAZOLE MAGNESIUM×2CSPC OUYIANDA 212949ABOct 02, 2020
ESOMEPRAZOLE MAGNESIUM×2CISENANDA 213158—Sep 22, 2020
ESOMEPRAZOLE MAGNESIUMMYLANANDA 212088—Jun 25, 2020
ESOMEPRAZOLE MAGNESIUM×2HETERO LABS LTD IIIANDA 211977ABJun 02, 2020
ESOMEPRAZOLE MAGNESIUMHETERO LABS LTD IIIANDA 212507—Jun 02, 2020
ESOMEPRAZOLE MAGNESIUMHETERO LABS LTD IIIANDA 208939—May 28, 2020
ESOMEPRAZOLE MAGNESIUMDR REDDYSANDA 211571—May 14, 2020
ESOMEPRAZOLE MAGNESIUMSUN PHARMANDA 212866—May 04, 2020
ESOMEPRAZOLE MAGNESIUMCIPLAANDA 211752ABMar 23, 2020
ESOMEPRAZOLE MAGNESIUM×2CIPLAANDA 211751ABMar 23, 2020
ESOMEPRAZOLE MAGNESIUMPHARMOBEDIENTANDA 212376—Oct 16, 2019
ESOMEPRAZOLE MAGNESIUMAMNEAL PHARMS NYANDA 209716—Jun 05, 2019
ESOMEPRAZOLE MAGNESIUM×2ZYDUS PHARMSANDA 206296ABMay 22, 2019
ESOMEPRAZOLE MAGNESIUM×2GLENMARK SPECLTANDA 209495—May 10, 2019
ESOMEPRAZOLE MAGNESIUM×2AMNEAL PHARMS NYANDA 209647—Apr 10, 2019
ESOMEPRAZOLE MAGNESIUMP AND LANDA 209202—Mar 05, 2019
ESOMEPRAZOLE MAGNESIUM×2HEC PHARMANDA 207265—May 18, 2018
ESOMEPRAZOLE MAGNESIUMDR REDDYSANDA 207673—May 15, 2018
ESOMEPRAZOLE MAGNESIUM×2SUN PHARMANDA 209735ABApr 30, 2018
ESOMEPRAZOLE MAGNESIUM×2ALKEM LABS LTDANDA 208333ABOct 20, 2017
ESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMAANDA 209339—Oct 16, 2017
ESOMEPRAZOLE MAGNESIUM×2LANNETT CO INCANDA 205563ABSep 01, 2017
ESOMEPRAZOLE MAGNESIUMPERRIGO R AND DANDA 207193—Aug 18, 2017
ESOMEPRAZOLE MAGNESIUM×2AUROBINDO PHARMA LTDANDA 205606ABApr 21, 2016
ESOMEPRAZOLE MAGNESIUM×2TORRENTANDA 203636—Oct 19, 2015
ESOMEPRAZOLE MAGNESIUM×2DR REDDYSANDA 078279ABSep 25, 2015
ESOMEPRAZOLE MAGNESIUM×2HETERO LABS LTD IIIANDA 202784—Sep 21, 2015
ESOMEPRAZOLE MAGNESIUM×2MYLANANDA 078936ABAug 02, 2015
ESOMEPRAZOLE MAGNESIUM×2CIPLAANDA 078003—Jan 26, 2015

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10076494Dec 08, 2036in 10 yr 8 mo
Product
10835488Dec 08, 2036in 10 yr 8 mo
Product

Esomeprazole magnesium — frequently asked questions

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

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