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Last Updated: August 17, 2022

NEXIUM Drug Patent 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. Seven 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 18th, 2013.

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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 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021957-003 Dec 15, 2011 See Plans and Pricing See Plans and Pricing
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 See Plans and Pricing See Plans and Pricing
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 See Plans and Pricing See Plans and Pricing
Astrazeneca NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NEXIUM

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

Country Patent Number Title Estimated Expiration
European Patent Office 0652872 SEL DE MAGNESIUM OPTIQUEMENT PUR DE COMPOSE DE PYRIDINYLMETHYLE SULFINYL-1H-BENZIMIDAZOLE (OPTICALLY PURE MAGNESIUM -SALT OF PYRIDINYLMETHYL SULFINYL-1H-BENZIMIDAZOLE COMPOUND) See Plans and Pricing
Iceland 2075 See Plans and Pricing
Luxembourg 92017 See Plans and Pricing
Australia 7192287 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEXIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 91871 Luxembourg See Plans and Pricing 91871, EXPIRES: 20230525
0984957 2012/048 Ireland See Plans and Pricing 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 2011/016 Ireland See Plans and Pricing 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 122012000017 Germany See Plans and Pricing PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Moodys
Baxter
Merck
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.