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FDA Orange Book · active-ingredient family

Pantoprazole sodium

Pantoprazole sodium is approved as 5 brand and 42 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE · NDA 217512

5

Brand (NDA)

42

Generics (ANDA)

2

Listed patents

1

Exclusivity periods

Brand (NDA) products · for suspension, delayed release, injectable, powder, solution, tablet, delayed release

ProductApplicantApplicationTEApproved
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDERLD×3BAXTER HLTHCARE CORPNDA 217512—Feb 14, 2024
PANTOPRAZOLE SODIUMRLDHIKMANDA 209463APJun 30, 2017
PROTONIXRLDWYETH PHARMSNDA 022020ABNov 14, 2007
PROTONIXRLD×2WYETH PHARMSNDA 020987ABJun 12, 2001
PROTONIX IVRLDWYETH PHARMSNDA 020988APMar 22, 2001

Generic (ANDA) products (42)

ProductApplicantApplicationTEApproved
PANTOPRAZOLE SODIUMSHUANGCHENGANDA 219973APApr 22, 2026
PANTOPRAZOLE SODIUMDEVA HOLDING ASANDA 215074APMay 16, 2025
PANTOPRAZOLE SODIUMAUROBINDO PHARMA LTDANDA 217923ABMar 31, 2025
PANTOPRAZOLE SODIUMCIPLAANDA 217458ABMar 31, 2025
PANTOPRAZOLE SODIUMALEMBICANDA 219230APMar 31, 2025
PANTOPRAZOLE SODIUM×2GRAVITI PHARMSANDA 219087ABJan 16, 2025
PANTOPRAZOLE SODIUMFRESENIUS KABI USAANDA 216021APAug 01, 2024
PANTOPRAZOLE SODIUM×2MANKIND PHARMAANDA 215880—Apr 25, 2024
PANTOPRAZOLE SODIUM×2GRANULESANDA 217282ABDec 11, 2023
PANTOPRAZOLE SODIUMANNORA PHARMAANDA 216139ABOct 27, 2023
PANTOPRAZOLE SODIUMDEXCELANDA 216247ABJun 16, 2023
PANTOPRAZOLE SODIUMAJANTA PHARMA LTDANDA 217416ABFeb 09, 2023
PANTOPRAZOLE SODIUMMEITHEALANDA 215860APAug 29, 2022
PANTOPRAZOLE SODIUMKNACKANDA 214680APMay 19, 2022
PANTOPRAZOLE SODIUMASPIROANDA 213778APMay 18, 2022
PANTOPRAZOLE SODIUMBE PHARMSANDA 216171APMay 18, 2022
PANTOPRAZOLE SODIUMGLANDANDA 204400APMay 18, 2022
PANTOPRAZOLE SODIUMHANGZHOU ZHONGMEIANDA 209524APAug 30, 2021
PANTOPRAZOLE SODIUMSUN PHARMANDA 213725ABJun 30, 2020
PANTOPRAZOLE SODIUMSUN PHARMANDA 077674—Aug 19, 2019
PANTOPRAZOLE SODIUMINGENUS PHARMS LLCANDA 211368—Mar 01, 2019
PANTOPRAZOLE SODIUMPHARMOBEDIENTANDA 208580—May 04, 2018
PANTOPRAZOLE SODIUMEUGIA PHARMAANDA 205675APMar 30, 2016
PANTOPRAZOLE SODIUM×2AMNEAL PHARMSANDA 205119ABJan 26, 2016
PANTOPRAZOLE SODIUMSANDOZANDA 090296—Jul 14, 2015
PANTOPRAZOLE SODIUM×2ORBION PHARMSANDA 202052ABDec 02, 2014
PANTOPRAZOLE SODIUM×2HETERO LABS LTD VANDA 202882ABSep 10, 2014
PANTOPRAZOLE SODIUML PERRIGO COANDA 203024—May 07, 2014
PANTOPRAZOLE SODIUMEPIC PHARMA LLCANDA 079197APNov 08, 2012
PANTOPRAZOLE SODIUM×2AUROBINDO PHARMA LTDANDA 202038ABSep 28, 2012
PANTOPRAZOLE SODIUM×2RUBICON RESEARCHANDA 090807ABMay 02, 2012
PANTOPRAZOLE SODIUM×2SUN PHARM INDS LTDANDA 200794—May 02, 2012
PANTOPRAZOLE SODIUM×2MACLEODS PHARMS LTDANDA 200821—Feb 16, 2012
PANTOPRAZOLE SODIUM×2JUBILANT GENERICSANDA 090901—Aug 30, 2011
PANTOPRAZOLE SODIUM×2ACTAVIS TOTOWAANDA 090797—Feb 07, 2011
PANTOPRAZOLE SODIUM×2LANNETT CO INCANDA 078281ABJan 20, 2011
PANTOPRAZOLE SODIUM×2APOTEXANDA 091231ABJan 19, 2011
PANTOPRAZOLE SODIUM×2DR REDDYS LABS LTDANDA 077619ABJan 19, 2011
PANTOPRAZOLE SODIUM×2MYLAN PHARMS INCANDA 090970ABJan 19, 2011
PANTOPRAZOLE SODIUM×2TORRENT PHARMSANDA 090074ABJan 19, 2011
PANTOPRAZOLE SODIUM×2SUN PHARMANDA 077058—Sep 10, 2007
PANTOPRAZOLE SODIUM×2TEVAANDA 077056—Aug 02, 2007

Marketing exclusivity (1)

  • NPPNew patient population exclusivity (3 years)

    Aug 12, 2027

    in 1 yr 2 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7544370Jun 07, 202612 d ago
Product
7544370*PEDDec 07, 2026in 6 mo

Pantoprazole sodium — 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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