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Serving leading biopharmaceutical companies globally:

UBS
US Department of Justice
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Generated: December 18, 2017

DrugPatentWatch Database Preview

NEXIUM Drug Profile

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Which patents cover Nexium, and what generic alternatives are available?

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 five 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca LpNEXIUM 24HResomeprazole magnesiumCAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca LpNEXIUM 24HResomeprazole magnesiumTABLET, DELAYED RELEASE;ORAL207920-001Nov 23, 2015OTCYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsNEXIUM IVesomeprazole sodiumINJECTABLE;INTRAVENOUS021689-002Mar 31, 2005APRXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumCAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001ABRXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-004Dec 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 PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 2008► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumCAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-002Oct 20, 2006► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-002Oct 20, 2006► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumCAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 2008► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for NEXIUM

Drugname Dosage Strength RLD Submissiondate
esomeprazole magnesiumDelayed-release for Oral Suspension20 mg and 40 mgNexium 215978/1/2013
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
8,076,361Form of S-omeprazole► Subscribe
7,745,466Form 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
Morocco23257► Subscribe
JapanH08512315► Subscribe
Hungary225987► Subscribe
Slovakia284837► Subscribe
Germany69909316► Subscribe
Denmark1124539► Subscribe
HungaryT75314► Subscribe
Yugoslavia49193► Subscribe
Hong Kong1034510► Subscribe
New Zealand268693► 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
2012 00035Denmark► SubscribePRODUCT 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
2012000051Germany► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
2011005,C0984957Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
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
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0Finland► Subscribe
12/048Ireland► SubscribePRODUCT 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
2012 00035Denmark► Subscribe
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
2012000017Germany► SubscribePRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Merck
Citi
Harvard Business School
Chinese Patent Office
Teva
Deloitte
Mallinckrodt
Medtronic

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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