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Last Updated: January 30, 2023

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, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Sun Pharm, Torrent, Zydus Pharms, Astrazeneca, Aurobindo Pharma, Perrigo R And D, Astrazeneca Lp, Cipla, P And L, Dexcel, Actavis Labs Fl Inc, Ajanta Pharma Ltd, and Horizon, and is included in forty-five NDAs. There are eleven 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. Ninety-four 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
See Plans and PricingSee Plans and PricingEQ 20MG BASE;500MGTABLET, DELAYED RELEASE;ORAL
See Plans and PricingSee Plans and PricingEQ 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
Graviti Pharms ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 213486-002 Mar 19, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-002 Apr 30, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon VIMOVO esomeprazole magnesium; naproxen TABLET, DELAYED RELEASE;ORAL 022511-001 Apr 30, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 See Plans and Pricing See Plans and Pricing
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for esomeprazole magnesium

Country Patent Number Title Estimated Expiration
European Patent Office 3471708 COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) See Plans and Pricing
Australia 2017285390 Stable orally disintegrating pharmaceutical compositions See Plans and Pricing
European Patent Office 3932396 COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for esomeprazole magnesium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 SPC/GB11/015 United Kingdom See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0124495 SPC/GB01/006 United Kingdom See Plans and Pricing PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0984957 SPC/GB11/013 United Kingdom See Plans and Pricing 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:

Merck
AstraZeneca
Medtronic
Boehringer Ingelheim
Moodys
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.