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Details for Generic Name: esomeprazole sodium

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Esomeprazole sodium is the generic ingredient in two branded drugs marketed by Sun Pharma Global and Astrazeneca Pharms, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-three patent family members in forty countries.

There are fifty-four drug master file entries for esomeprazole sodium. Two suppliers are listed for this compound.

Summary for Generic Name: esomeprazole sodium

Drug Master File Entries: see list54
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details

Pharmacology for Ingredient: esomeprazole sodium

Clinical Trials for: esomeprazole sodium

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

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

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 Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
Status: Recruiting Condition: Upper Gastrointestinal Bleeding

A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
Status: Completed Condition: Arthritis

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

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

Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy
Status: Completed Condition: Peptic Ulcer; Bleeding

Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD
Status: Recruiting Condition: Gastroesophageal Reflux Disease

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 Pharms
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 2005RXYes6,143,771<disabled>Y <disabled>
Astrazeneca Pharms
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 2005RXYes5,877,192*PED<disabled> <disabled>
Sun Pharma Global
esomeprazole sodium
INJECTABLE;INTRAVENOUS200882-002Mar 18, 2013RXNo<disabled><disabled>
Astrazeneca Pharms
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 2005RXYes<disabled><disabled>
Astrazeneca Pharms
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 2005RXYes6,143,771<disabled>Y <disabled>
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International Patent Family for Ingredient: esomeprazole sodium

Country Document Number Publication Date
Spain2099047Mar 01, 2001
Japan4039999Jan 30, 2008
Czech Republic9500202Oct 18, 1995
Slovenia9420002Aug 31, 1995
Slovakia10195Sep 13, 1995
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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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