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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.

Summary for ESOMEPRAZOLE MAGNESIUM

International Patents:	24
US Patents:	12
Tradenames:	5
Applicants:	19
NDAs:	33
Drug Master File Entries:	74
Suppliers / Packagers:	87
Bulk Api Vendors:	45
Clinical Trials:	16
Patent Applications:	1,352
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
DailyMed Link:	ESOMEPRAZOLE MAGNESIUM at DailyMed

See drug prices 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
Icahn School of Medicine at Mount Sinai	Phase 2
University of Texas Southwestern Medical Center	Phase 3
Takeda	Phase 3

See all ESOMEPRAZOLE MAGNESIUM clinical trials

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM

Applicant	Application No.	Strength	Dosage Form
		EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE;ORAL
		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	Proton Pump Inhibitors Cytochrome P450 2C19 Inhibitors

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

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
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022101-001	Feb 27, 2008
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001

International Patents for ESOMEPRAZOLE MAGNESIUM

Country	Patent Number	Estimated Expiration
Australia	1434600
Brazil	9915087
Norway	20012222
Slovenia	1124539
World Intellectual Property Organization (WIPO)	0027366

Supplementary Protection Certificates for ESOMEPRAZOLE MAGNESIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011/016	Ireland		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		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0984957	2012/048	Ireland		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		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105