NEXIUM IV Drug Patent Profile

When do Nexium Iv patents expire, and what generic alternatives are available?

Nexium Iv is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in NEXIUM IV is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexium Iv

A generic version of NEXIUM IV was approved as esomeprazole sodium by SUN PHARM on March 18^th, 2013.

Summary for NEXIUM IV

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	162
Patent Applications:	100
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEXIUM IV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXIUM IV
DailyMed Link:	NEXIUM IV at DailyMed

See drug prices for NEXIUM IV

Recent Clinical Trials for NEXIUM IV

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

Sponsor	Phase
Alexandria University	Phase 3
Nanfang Hospital of Southern Medical University	Phase 4
Liaocheng People's Hospital	Phase 1

See all NEXIUM IV clinical trials

Pharmacology for NEXIUM IV

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

Paragraph IV (Patent) Challenges for NEXIUM IV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NEXIUM IV	For Injection	esomeprazole sodium	20 mg/vial and 40 mg/vial	021689	1	2009-11-23

US Patents and Regulatory Information for NEXIUM IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005		DISCN	Yes	No
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005	AP	RX	Yes	Yes

Expired US Patents for NEXIUM IV

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-002	Mar 31, 2005
Astrazeneca	NEXIUM IV	esomeprazole sodium	INJECTABLE;INTRAVENOUS	021689-001	Mar 31, 2005

International Patents for NEXIUM IV

See the table below for patents covering NEXIUM IV around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	109684	OPTICALLY PURE CRYSTALLINE SALTS OF THE (-)-ENANTIOMER OF OMEPRAZOLE, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Australia	676337
Poland	178994
Japan	4039999

Supplementary Protection Certificates for NEXIUM IV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020461	91870	Luxembourg
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
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105