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Profile for Tradename: NEXIUM

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

The generic ingredient in NEXIUM is esomeprazole sodium. There are fifty-four 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

Suppliers / Packagers: see list55
2013 Sales:$6,135,667,000

Pharmacology for Tradename: NEXIUM

Clinical Trials for: NEXIUM

Nexium Study To Suppress Nausea During Chemotherapy
Status: Terminated Condition: Nausea

Viokase 16, Viokase16 Plus Nexium and Nexium Alone
Status: Terminated Condition: Chronic Pancreatitis

Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers
Status: Completed Condition: Healthy

Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
Status: Completed Condition: Gastroesophageal Reflux Disease

The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes
Status: Completed Condition: Type 2 Diabetes

A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued
Status: Completed Condition: NSAID Associated Gastric Ulcers

Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv
Status: Completed Condition: Gastroesophageal Reflux Disease

Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
Status: Recruiting Condition: Gastroesophageal Reflux Disease (GERD); Heartburn; Indigestion

Study to Evaluate the Interaction Between Aspirin and Nexium
Status: Completed Condition: Healthy Volunteers

Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances
Status: Recruiting Condition: Gastroesophageal Reflux Disease; Heartburn; Sleep Disturbance

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Lp
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYes6,875,872*PED<disabled> <disabled>
Astrazeneca Pharms
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 2008RXNo7,411,070*PED<disabled>Y<disabled>
Astrazeneca Pharms
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011RXNo5,690,960*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

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
5,693,818 Process for preparing pure salts of pyridinylmethyl-sulfinyl-1H-benzimidazole<disabled in preview>
6,143,771 Compounds<disabled in preview>
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Preferred citation:

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

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