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Last Updated: April 20, 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, Aurobindo Pharma, Guardian Drug, 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 eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for esomeprazole magnesium

International Patents:	4
US Patents:	2
Tradenames:	5
Applicants:	35
NDAs:	53
Drug Master File Entries:	59
Finished Product Suppliers / Packagers:	111
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	19
Patent Applications:	6,044
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for esomeprazole magnesium
Drug Sales Revenues:	Drug sales revenues for esomeprazole magnesium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for esomeprazole magnesium
What excipients (inactive ingredients) are in esomeprazole magnesium?	esomeprazole magnesium excipients list
DailyMed Link:	esomeprazole magnesium at DailyMed

See drug prices for esomeprazole magnesium

Drug Sales Revenue Trends for esomeprazole magnesium

See drug sales revenues for esomeprazole magnesium

Recent Clinical Trials for esomeprazole magnesium

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

Sponsor	Phase
Daewoong Pharmaceutical Co. LTD.	Phase 3
Icahn School of Medicine at Mount Sinai	Phase 2
University of Texas Southwestern Medical Center	Phase 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 Trial	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 20MG BASE;375MG	TABLET, 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

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lannett Co Inc	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	205563-001	Sep 1, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dexcel	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	214278-001	Oct 20, 2020		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Zydus Pharms	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	206055-002	Jun 7, 2023	AB	RX	No	No	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011	⤷ 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 Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for esomeprazole magnesium

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3932396	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)	⤷ Try a Trial
Australia	2017285390	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

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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
0984957	SPC/GB11/013	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.