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Last Updated: August 9, 2020

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ESOMEPRAZOLE MAGNESIUM - Generic Drug Details

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What are the generic drug sources for esomeprazole magnesium and what is the scope of patent protection?

Esomeprazole magnesium is the generic ingredient in five branded drugs 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, Astrazeneca Pharms, Perrigo R And D, Astrazeneca Lp, Cipla, P And L, and Horizon, and is included in thirty-three NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium has twenty-four patent family members in nineteen countries.

There are seventy-four drug master file entries for esomeprazole magnesium. Eighty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

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

Identify potential brand extensions & 505(b)(2) entrants

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

See all ESOMEPRAZOLE MAGNESIUM clinical trials

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 20MG BASE;500MGTABLET, DELAYED RELEASE;ORAL
  Start Trial  Start TrialEQ 20MG BASE;375MGTABLET, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Amneal Pharms Ny ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 209716-001 Jun 5, 2019 OTC No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 208333-002 Oct 20, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Ny ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 209647-002 Apr 10, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 078936-001 Aug 2, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes   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

Expired US Patents for ESOMEPRAZOLE MAGNESIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-003 Dec 15, 2011   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ESOMEPRAZOLE MAGNESIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011/016 Ireland   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957 SPC/GB11/013 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0124495 SPC/GB01/006 United Kingdom   Start Trial PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0984957 2012/048 Ireland   Start Trial PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Moodys
Dow
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Johnson and Johnson

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