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, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Speclt, 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, Norvium Bioscience, 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-five 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:	36
NDAs:	55
Drug Master File Entries:	59
Finished Product Suppliers / Packagers:	111
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	19
Patent Applications:	6,066
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
⤷ Sign Up	⤷ Sign Up	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for ESOMEPRAZOLE MAGNESIUM

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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
Dr Reddys	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	204206-001	Feb 18, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	217738-001	Oct 11, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	078279-001	Sep 25, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-002	Oct 20, 2006	⤷ Sign Up	⤷ Sign Up
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011	⤷ Sign Up	⤷ Sign Up
>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
World Intellectual Property Organization (WIPO)	2017216789		⤷ Sign Up
European Patent Office	3471708	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)	⤷ Sign Up
Australia	2017285390	Stable orally disintegrating pharmaceutical compositions	⤷ Sign Up
European Patent Office	3932396	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)	⤷ Sign Up
>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
0984957	SPC/GB11/013	United Kingdom	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	2011C/016	Belgium	⤷ Sign Up	PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900	2011/016	Ireland	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom	⤷ Sign Up	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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