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NEXIUM Drug Profile

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Nexium is a drug marketed by Astrazeneca Pharms and Astrazeneca Lp and is included in six NDAs. It is available from fourteen suppliers. There are nine patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and thirty-nine patent family members in forty-eight countries.

The generic ingredient in NEXIUM is esomeprazole sodium. There are sixty drug master file entries for this compound. Five 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:9
Applicants:2
NDAs:6
Suppliers / Packagers: see list14

Pharmacology for Tradename: NEXIUM

Clinical Trials for: NEXIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-002Oct 20, 2006RXYes7,411,070*PED<disabled>Y<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-004Dec 15, 2011RXNo7,411,070*PED<disabled>Y<disabled>
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 2015OTCYes5,900,424*PED<disabled>Y<disabled>
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Expired Patents for Tradename: NEXIUM

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20014,853,230*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 20064,738,974*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 20065,877,192*PED<disabled>
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Paragraph IV activity for: NEXIUM

Drugname Dosage Strength RLD Submissiondate
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
8,076,361Form of S-omeprazole<disabled in preview>
5,693,818 Process for preparing pure salts of pyridinylmethyl-sulfinyl-1H-benzimidazole<disabled in preview>
6,677,455 Potassium salt of S-omeprazole<disabled in preview>
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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
Austria212628<disabled in preview>
Germany652872<disabled in preview>
Germany69435221<disabled in preview>
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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
11/016Ireland<disabled>PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
C/GB11/013United Kingdom<disabled>PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
00483Netherlands<disabled>PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
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