NEXIUM 24HR Drug Patent Profile

Which patents cover Nexium 24hr, and when can generic versions of Nexium 24hr launch?

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
IQVIA RDS Inc.	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	TABLET, DELAYED RELEASE;ORAL	207920-001	Nov 23, 2015
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
European Patent Office	1124539	FORMULATION PHARMACEUTIQUE CONTENANT DE L'OMEPRAZOLE (PHARMACEUTICAL FORMULATION COMPRISING OMEPRAZOLE)
Australia	7198294
Slovenia	0984957
Canada	2166483	NOUVELLE FORMULATION PHARMACEUTIQUE (NEW PHARMACEUTICAL FORMULATION)

Supplementary Protection Certificates for NEXIUM 24HR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	1290006-4	Sweden		PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
0984957	122012000017	Germany		PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812