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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Queensland Health
Citi
Medtronic
Fuji
Farmers Insurance
Fish and Richardson
Julphar
Express Scripts

Generated: October 17, 2017

DrugPatentWatch Database Preview

NEXIUM Drug Profile

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Which patents cover Nexium, 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 are eight patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and eighty-one patent family members in forty-six countries and twenty supplementary protection certificates in ten countries.

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

Summary for Tradename: NEXIUM

US Patents:8
Applicants:2
NDAs:6
Suppliers / Packagers: see list12
Bulk Api Vendors: see list217
Clinical Trials: see list123
Patent Applications: see list17
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NEXIUM at DailyMed

Pharmacology for Tradename: NEXIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 2015OTCYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 2005APRXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-004Dec 15, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: NEXIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 2008► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-004Dec 15, 2011► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for NEXIUM

Drugname Dosage Strength RLD Submissiondate
esomeprazoleDelayed-release Tablets20 mgNexium 24HR (OTC)9/9/2016
esomeprazole magnesiumDelayed-release Capsules20 mgNexium (OTC)4/24/2014
esomeprazole sodiumFor Injection20 mg/vial and 40 mg/vialNexium IV11/23/2009
esomeprazole magnesiumDelayed-release20 mg and 40 mgNexium8/5/2005

Non-Orange Book Patents for Tradename: NEXIUM

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,677,455 Potassium salt of S-omeprazole► Subscribe
7,745,466Form of S-omeprazole► Subscribe
8,076,361Form of S-omeprazole► Subscribe
6,747,155 Process► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: NEXIUM

Country Document Number Estimated Expiration
Portugal984957► Subscribe
Spain2195345► Subscribe
South Africa9404933► Subscribe
Malaysia120745► Subscribe
Brazil9912883► Subscribe
Finland960101► Subscribe
Germany69829511► Subscribe
Taiwan538040► Subscribe
Denmark0707580► Subscribe
European Patent Office1273581► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NEXIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90006-4Sweden► SubscribePRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
11/016Ireland► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
2012000017Germany► SubscribePRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
2011005Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
00517Netherlands► SubscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
871Luxembourg► Subscribe91871, EXPIRES: 20230525
2012 00008Denmark► Subscribe
0984957/02Switzerland► SubscribePRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012
C/GB01/006United Kingdom► SubscribePRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
2011005,C0984957Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Healthtrust
Medtronic
Deloitte
Baxter
Moodys
McKinsey
McKesson
Cantor Fitzgerald
Colorcon
US Department of Justice

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 verifification 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.

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