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Last Updated: August 12, 2020

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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 Pharms and Astrazeneca Lp and is included in six NDAs. There is one patent protecting this drug and seven Paragraph IV challenges.

This drug has twenty-four patent family members in nineteen countries.

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.

US ANDA 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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Drug patent expirations by year for NEXIUM
Drug Prices for NEXIUM

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Drug Sales Revenue Trends for NEXIUM

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Recent Clinical Trials for NEXIUM

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SponsorPhase
University of AlexandriaPhase 4
Alexandria UniversityPhase 4
Yooyoung Pharmaceutical Co., Ltd.Phase 1

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Pharmacology for NEXIUM
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 Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
>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 Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-003 Dec 15, 2011   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001   Start Trial   Start Trial
>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 122012000017 Germany   Start Trial PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
0984957 C00984957/02 Switzerland   Start Trial PRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012
1411900 2011/016 Ireland   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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