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Last Updated: March 19, 2024

Esomeprazole magnesium - Generic Drug Details


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What are the generic 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, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Pharms, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Astrazeneca, Anda Repository, Aurobindo Pharma, Marksans Pharma, Perrigo R And D, Astrazeneca Lp, Cipla, P And L, Dexcel, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Sciegen Pharms Inc, and Horizon, and is included in fifty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium has four patent family members in three countries.

There are fifty-nine drug master file entries for esomeprazole magnesium. One hundred and ten 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
Daewoong Pharmaceutical Co. LTD.Phase 3
Icahn School of Medicine at Mount SinaiPhase 2
University of Texas Southwestern Medical CenterPhase 3

See all esomeprazole magnesium clinical trials

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 20MG BASE;500MGTABLET, DELAYED RELEASE;ORAL
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
NEXIUM Delayed-release for Oral Suspension esomeprazole magnesium 2.5 mg and 5 mg 021957 1 2018-09-24
NEXIUM Delayed-release for Oral Suspension esomeprazole magnesium 10 mg 022101 1 2018-07-06
NEXIUM 24HR Delayed-release Capsules esomeprazole magnesium 20 mg 204655 2014-04-24
NEXIUM Delayed-release for Oral Suspension esomeprazole magnesium 20 mg and 40 mg 021957 1 2013-08-01
NEXIUM Delayed-release Capsules esomeprazole magnesium 20 mg and 40 mg 021153 1 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
Cipla ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 211751-001 Mar 23, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 209735-002 Apr 30, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sciegen Pharms Inc NAPROXEN AND ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 217738-001 Oct 11, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd Iii ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 211977-002 Jun 2, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sciegen Pharms Inc NAPROXEN AND ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 217738-002 Oct 11, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for esomeprazole magnesium

Country Patent Number Title Estimated Expiration
Australia 2017285390 Stable orally disintegrating pharmaceutical compositions ⤷  Try a Trial
European Patent Office 3932396 COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
European Patent Office 3471708 COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2017216789 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for esomeprazole magnesium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011/016 Ireland ⤷  Try a 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
0124495 SPC/GB01/006 United Kingdom ⤷  Try a Trial PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0984957 2012/048 Ireland ⤷  Try a 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
0984957 SPC/GB11/013 United Kingdom ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 SPC/GB11/015 United Kingdom ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 2011C/016 Belgium ⤷  Try a Trial PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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