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Profile for Tradename: NEXIUM

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Nexium is a drug marketed by Astrazeneca and Astrazeneca Lp and is included in five NDAs. It is available from eleven suppliers. There are twenty-one patents protecting this drug and three Paragraph IV challenges.

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

Summary for Tradename: NEXIUM

Patents:21
Applicants:2
NDAs:5
Suppliers: see list11
2013 Sales:$6,135,667,000

Pharmacology for Tradename: NEXIUM

Clinical Trials for: NEXIUM

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153Feb 20, 2001RXYes7,411,070*PED<disabled>Y<disabled>
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655Mar 28, 2014OTCYes5,900,424<disabled>Y<disabled>
Astrazeneca
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153Feb 20, 2001RXYes5,714,504*PED<disabled>Y<disabled>
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655Mar 28, 2014OTCYes5,690,960<disabled>Y<disabled>
Astrazeneca
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153Feb 20, 2001RXNo6,147,103*PED<disabled>Y<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
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ISSN: 2162-2639

Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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