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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 Accord Hlthcare, Sun Pharma Global, and Astrazeneca Pharms, and is included in three 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-six drug master file entries for esomeprazole sodium. Two suppliers are listed for this compound.

Summary for Generic Name: esomeprazole sodium

Tradenames:2
Patents:2
Applicants:3
NDAs:3
Drug Master File Entries: see list56
Suppliers / Packaging: see list3

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

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 ClinicalTrials.org
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
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 2005RXYes<disabled><disabled>
Sun Pharma Global
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS200882-002Mar 18, 2013RXNo<disabled><disabled>
Accord Hlthcare
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS205379-001Sep 25, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: esomeprazole sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 20055,877,192*PED<disabled>
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 20055,877,192*PED<disabled>
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 20056,143,771<disabled>
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International Patent Family for Ingredient: esomeprazole sodium

Country Document Number Publication Date
Poland307261May 15, 1995
South Africa9403557Apr 11, 1995
CroatiaP940307Jun 30, 2001
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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