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NEXIUM 24HR Drug Profile

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Which patents cover Nexium 24hr, and what substitute generic drugs are available?

Nexium 24hr is a drug marketed by Astrazeneca Lp and is included in two NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are sixty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for Tradename: NEXIUM 24HR

Patents:4
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list25
Clinical Trials: see list47
Patent Applications: see list17
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NEXIUM 24HR at DailyMed
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, 2015OTCYesYes5,900,424*PED► Subscribe ► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYesYes6,369,085*PED► SubscribeY► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 2015OTCYesYes6,369,085*PED► SubscribeY► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYesYes6,428,810*PED► SubscribeY► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 2015OTCYesYes6,428,810*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: NEXIUM 24HR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20145,900,424*PED► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20145,690,960*PED► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20145,877,192*PED► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20145,714,504*PED► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 20155,900,424*PED► Subscribe
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Paragraph IV activity for: NEXIUM 24HR

Drugname Dosage Strength RLD Submissiondate
esomeprazoleDelayed-release Tablets20 mgNexium 24HR (OTC)9/9/2016

Non-Orange Book Patents for Tradename: NEXIUM 24HR

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
8,466,175Form of S-omeprazole► Subscribe
8,076,361Form of S-omeprazole► Subscribe
6,747,155 Process► 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 24HR

Country Document Number Estimated Expiration
Malaysia120745► Subscribe
Hungary9503873► Subscribe
Japan3635432► Subscribe
South Africa9404933► Subscribe
Japan2007161734► 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 24HR

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
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
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
2012 00035Denmark► Subscribe
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