NEXIUM Drug Patent Profile

When do Nexium patents expire, and when can generic versions of Nexium launch?

Nexium is a drug marketed by Astrazeneca and Astrazeneca Lp and is included in six NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexium

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

Summary for NEXIUM

US Patents:	0
Applicants:	2
NDAs:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	160
Patent Applications:	4,583
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEXIUM
Drug Sales Revenues:	Drug sales revenues for NEXIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXIUM
What excipients (inactive ingredients) are in NEXIUM?	NEXIUM excipients list
DailyMed Link:	NEXIUM at DailyMed

See drug prices for NEXIUM

See drug sales revenues for NEXIUM

Recent Clinical Trials for NEXIUM

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

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

See all NEXIUM clinical trials

Pharmacology for NEXIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for NEXIUM

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

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	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

US Patents and Regulatory Information for NEXIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-001	Feb 20, 2001	AB	RX	Yes	No
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-002	Oct 20, 2006	AB	RX	Yes	Yes
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011		RX	Yes	No
Astrazeneca Lp	NEXIUM 24HR	esomeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	204655-001	Mar 28, 2014		OTC	Yes	Yes
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001	AB	RX	Yes	Yes
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011		RX	Yes	No
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-001	Oct 20, 2006	AB	RX	Yes	No

Expired US Patents for NEXIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-001	Oct 20, 2006
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-003	Dec 15, 2011
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-002	Oct 20, 2006
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001
Astrazeneca	NEXIUM	esomeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	021957-004	Dec 15, 2011
Astrazeneca	NEXIUM	esomeprazole magnesium	CAPSULE, DELAYED REL PELLETS;ORAL	021153-002	Feb 20, 2001

International Patents for NEXIUM

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

Country	Patent Number	Title	Estimated Expiration
Hungary	901539
Austria	197452
Israel	109684	OPTICALLY PURE CRYSTALLINE SALTS OF THE (-)-ENANTIOMER OF OMEPRAZOLE, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Slovenia	22752	Optično čiste soli piridinilmetil sulfinil-1H-benzimidazolovih spojin (OPTICALLY PURE SALTS OF PYRIDINYLMETHYL SULPHINYL-1-H-BENZIMIDAZOLE COMPOUNDS)
Austria	374473
Iceland	4186
Poland	265417

Supplementary Protection Certificates for NEXIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0005129	SPC/GB99/015	United Kingdom		SPC/GB99/015, EXPIRES: 20021115
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1020461	91870	Luxembourg
0984957	CA 2012 00035	Denmark