ESOMEPRAZOLE MAGNESIUM Drug Patent Profile

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Esomeprazole Magnesium is a drug 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, Aurobindo Pharma, Guardian Drug, Marksans Pharma, Perrigo R And D, Cipla, P And L, and Dexcel. and is included in forty-two NDAs. There are two patents protecting this drug.

This drug has four patent family members in three countries.

The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and eleven suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

A generic version of ESOMEPRAZOLE MAGNESIUM was approved as esomeprazole magnesium by IVAX SUB TEVA PHARMS on January 26^th, 2015.

International Patents:	4
US Patents:	2
Applicants:	29
NDAs:	42
Finished Product Suppliers / Packagers:	109
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	19
Patent Applications:	3,611
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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

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

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

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

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

ESOMEPRAZOLE MAGNESIUM is protected by two US patents.

Stable orally disintegrating pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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
Torrent	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	203636-001	Oct 19, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ivax Sub Teva Pharms	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	078003-002	Jan 26, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	207673-001	May 15, 2018		OTC	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

See the table below for patents covering ESOMEPRAZOLE MAGNESIUM around the world.

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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
European Patent Office	3471708	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1411900	SPC/GB11/015	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description