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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 esomeprazole magnesium freedom to operate?

Esomeprazole magnesium is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hec Pharm, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan Pharms Inc, Sun Pharm Inds Ltd, Torrent, Astrazeneca Pharms, Perrigo R And D, Astrazeneca Lp, Actavis Elizabeth, and Horizon, and is included in twenty NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium has forty-nine patent family members in nineteen countries.

There are seventy-four drug master file entries for esomeprazole magnesium. Eighty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ESOMEPRAZOLE MAGNESIUM

International Patents:	49
US Patents:	15
Tradenames:	4
Applicants:	15
NDAs:	20
Drug Master File Entries:	74
Suppliers / Packagers:	80
Bulk Api Vendors:	79
Clinical Trials:	16
Patent Applications:	25
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

Pharmacology for ESOMEPRAZOLE MAGNESIUM

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

Synonyms for ESOMEPRAZOLE MAGNESIUM

(s)-omeprazole magnesium trihydrate

161796-78-7

161973-10-0

1H-Benzimidazole, 5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-, magnesium salt, trihydrate

217087-09-7

382E335

5-methoxy-1H-1,3-benzimidazol-2-yl (4-methoxy-3,5-dimethyl-2-pyridinyl)methyl sulfoxide

5-Methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, magnesium salt (2:1)

5-Methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, magnesium salt (2:1), trihydrate

95382-33-5

A810316

AB00698386-07

AB2000267

AC-402

AC-4540

AC1L2XM7

AC1L2XMA

AC1NSJYQ

ACN-036633

AK172773

AKOS015896379

AKOS015967196

AKOS025311414

AKOS025402081

AN-11885

AN-15879

AN-34918

azol-1-ide

BCP05838

CCG-100986

CE0112

CHEBI:94401

CHEMBL1567328

CPD004727568

CS-1024

CTK8E8954

D05259

Esomeprazole (Magnesium trihydrate)

Esomeprazole magnesium (Nexium)

Esomeprazole magnesium trihydrate

ESOMEPRAZOLE Mg

Esomeprazole Sodium

Esomeprazole(magnesium)

FT-0625712

FT-0657297

H 168/68 magnesium

H199/18

HMS2051H21

HMS2235F19

HMS2878H13

HMS3372O13

HMS3393H21

HY-17022

I06-1976

J-014249

KS-1054

KWORUUGOSLYAGD-UHFFFAOYSA-N

LS-181810

magnesium 5-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide 6-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imid

magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]benzimidazol-1-ide

magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide

magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide trihydrate

magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide trihydrate

magnesium bis(5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide)

Magnesium, bis(5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl-kappaO)-1H-benzimidazolato-kappaN1)-, trihydrate, (T-4)-

magnesium;5-methoxy-2-[(R)-(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide;tri

magnesium(2+) bis(5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1H-1,3-benzodiazol-1-ide)

MFCD07698573 (95%)

MLS001165732

MLS001401413

MolPort-005-940-841

MolPort-016-633-260

MRF-0000267

N Bis (1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl]-)

NC00236

Nexium

Omeprazole magnesium

omeprazole magnesium (10 mg)

Omeprazole magnesium (USAN)

Omeprazole magnesium [USAN:USP]

Omeprazole magnesium [USAN]

omeprazole magnesium, ep

omeprazole mg

Prilosec OTC (TN)

Q-100195

RT-012496

SAM001246538

SC-72064

SCHEMBL665194

SCHEMBL722792

SMR000469280

SMR000550477

ST24046692

STL455071

SW220306-1

SY108184

UNII-426QFE7XLK

VEVZQDGATGBLIC-UHFFFAOYSA-N

Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM

Applicant	Application No.	Strength	Dosage Form
		22MG	CAPSULE, 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.

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
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010		RX	Yes	Yes
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011		RX	Yes	No					Y
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010		RX	Yes	Yes
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010		RX	Yes	Yes			Y
Astrazeneca Pharms	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	AB	RX	Yes	No

Expired US Patents for ESOMEPRAZOLE MAGNESIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014
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
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	021153-002	Feb 20, 2001

International Patents for ESOMEPRAZOLE MAGNESIUM

Country	Patent Number	Estimated Expiration
China	1160062
Japan	2003516985
China	1325300
Slovenia	1124539
Canada	2393366

Supplementary Protection Certificates for ESOMEPRAZOLE MAGNESIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	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
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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