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Last Updated: October 22, 2020

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ESOMEPRAZOLE MAGNESIUM Drug Profile

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When do Esomeprazole Magnesium patents expire, and when can generic versions of Esomeprazole Magnesium launch?

Esomeprazole Magnesium is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Glenmark Pharms, Hec Pharm, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Sun Pharm, Torrent, Zydus Pharms, Perrigo R And D, Cipla, and P And L. and is included in twenty-seven NDAs.

The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. Ninety-one suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

US ANDA Litigation and Generic Entry Outlook for Esomeprazole Magnesium

A generic version of ESOMEPRAZOLE MAGNESIUM was approved as esomeprazole magnesium by IVAX SUB TEVA PHARMS on January 26th, 2015.

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Drug patent expirations by year for ESOMEPRAZOLE MAGNESIUM
Drug Prices for ESOMEPRAZOLE MAGNESIUM

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Drug Sales Revenue Trends for ESOMEPRAZOLE MAGNESIUM

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Recent Clinical Trials for ESOMEPRAZOLE MAGNESIUM

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SponsorPhase
Icahn School of Medicine at Mount SinaiPhase 2
University of Texas Southwestern Medical CenterPhase 3
TakedaPhase 3

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Pharmacology for ESOMEPRAZOLE MAGNESIUM
Paragraph IV (Patent) Challenges for ESOMEPRAZOLE MAGNESIUM
Tradename Dosage Ingredient NDA Submissiondate
NEXIUM FOR SUSPENSION, DELAYED RELEASE;ORAL esomeprazole magnesium 022101 2018-07-06
NEXIUM 24HR TABLET, DELAYED RELEASE;ORAL esomeprazole magnesium 207920 2016-09-09
NEXIUM 24HR CAPSULE, DELAYED RELEASE;ORAL esomeprazole magnesium 204655 2014-04-24
NEXIUM FOR SUSPENSION, DELAYED RELEASE;ORAL esomeprazole magnesium 021957 2013-08-01
NEXIUM CAPSULE, DELAYED REL PELLETS;ORAL esomeprazole magnesium 021153 2005-08-05

US Patents and Regulatory Information for ESOMEPRAZOLE MAGNESIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 212088-001 Jun 25, 2020 OTC No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 208939-001 May 28, 2020 OTC No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 206296-002 May 22, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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