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Last Updated: June 14, 2021

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NEXIUM Drug Profile


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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 PHARMA GLOBAL on March 18th, 2013.

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Paragraph IV (Patent) Challenges for NEXIUM
Tradename Dosage Ingredient NDA Submissiondate
NEXIUM FOR SUSPENSION, DELAYED RELEASE;ORAL esomeprazole magnesium 022101 2018-07-06
NEXIUM FOR SUSPENSION, DELAYED RELEASE;ORAL esomeprazole magnesium 021957 2013-08-01
NEXIUM CAPSULE, DELAYED REL PELLETS;ORAL esomeprazole magnesium 021153 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   Get Started Free   Get Started Free   Get Started Free
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 OTC Yes Yes   Get Started Free   Get Started Free   Get Started Free
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-003 Dec 15, 2011 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for NEXIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 CA 2012 00008 Denmark   Get Started Free
0005129 SPC/GB99/015 United Kingdom   Get Started Free SPC/GB99/015, EXPIRES: 20021115
0984957 PA2011005 Lithuania   Get Started Free PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957 CA 2012 00035 Denmark   Get Started Free
1020461 C300482 Netherlands   Get Started Free PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
0984957 2012/048 Ireland   Get Started Free 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 92017 Luxembourg   Get Started Free 92017, EXPIRES: 20230525
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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