NEXIUM 24HR Drug Patent Profile

Which patents cover Nexium 24hr, and what generic alternatives are available?

Nexium 24hr is a drug marketed by Astrazeneca Lp and is included in two NDAs.

The generic ingredient in NEXIUM 24HR 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexium 24hr

A generic version of NEXIUM 24HR was approved as esomeprazole magnesium by IVAX SUB TEVA PHARMS on January 26^th, 2015.

Summary for NEXIUM 24HR

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	160
Patent Applications:	1,278
Formulation / Manufacturing:	see details
Drug Sales Revenues:	Drug sales revenues for NEXIUM 24HR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXIUM 24HR
What excipients (inactive ingredients) are in NEXIUM 24HR?	NEXIUM 24HR excipients list
DailyMed Link:	NEXIUM 24HR at DailyMed

See drug sales revenues for NEXIUM 24HR

Recent Clinical Trials for NEXIUM 24HR

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

Sponsor	Phase
Nanfang Hospital of Southern Medical University	Phase 4
Liaocheng People's Hospital	Phase 1
Thermo Fisher Scientific	Phase 3

See all NEXIUM 24HR clinical trials

Pharmacology for NEXIUM 24HR

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

Anatomical Therapeutic Chemical (ATC) Classes for NEXIUM 24HR

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 NEXIUM 24HR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXIUM 24HR	Delayed-release Capsules	esomeprazole magnesium	20 mg	204655		2014-04-24

US Patents and Regulatory Information for NEXIUM 24HR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014		OTC	Yes	Yes
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015		OTC	Yes	Yes

Expired US Patents for NEXIUM 24HR

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 Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014

International Patents for NEXIUM 24HR

See the table below for patents covering NEXIUM 24HR around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	3287	OPTICAL PURE COMPOUNDS, A PROCESS FOR THEIR PREPARATION AND THEIR USE
Russian Federation	2137766	OPTICALLY PURE Na+, Mg2+, Li+, K OR Ca SALTS OF (-)-5-METHOXY-2-[[(4- -METHOXY-3,5-DIMETHYL-2-PYRIDINYL)METHYL]SULFINYL]-1H-BENZ-IMIDAZOLE, METHOD OF THEIR SYNTHESIS, PHARMACEUTICAL COMPOSITION BASED ON SAID AND INTERMEDIATE COMPOUND
Germany	69909316
Brazil	9915087

Supplementary Protection Certificates for NEXIUM 24HR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	92017	Luxembourg		92017, EXPIRES: 20230525
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
0984957	122012000051	Germany		PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214