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NEXIUM Drug Profile

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Which patents cover Nexium, and what substitute generic drugs 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 four Paragraph IV challenges.

This drug has one hundred and sixty-six patent family members in forty-five countries.

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

Summary for Tradename: NEXIUM

Patents:8
Applicants:2
NDAs:6
Suppliers / Packagers: see list13
Bulk Api Vendors: see list217
Clinical Trials: see list83
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 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, 2015OTCYesYes7,411,070*PED► SubscribeY► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 2006RXYesNo7,411,070*PED► SubscribeY► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYesYes6,369,085*PED► SubscribeY► Subscribe
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 2005RXYesYes► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-004Dec 15, 2011RXYesNo6,369,085*PED► 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
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 20115,900,424*PED► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 20014,636,499► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20015,093,342► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 20016,875,872*PED► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 20065,714,504*PED► Subscribe
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Paragraph IV activity 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
6,747,155 Process► Subscribe
8,076,361Form of S-omeprazole► Subscribe
7,745,466Form of S-omeprazole► 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
Hungary9503873► Subscribe
Iceland2774► Subscribe
New Zealand500991► Subscribe
Slovenia984957► 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
871Luxembourg► Subscribe91871, EXPIRES: 20230525
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
2011005Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
00483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
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
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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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