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Details for Generic Name: esomeprazole magnesium

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Esomeprazole magnesium is the generic ingredient in five branded drugs marketed by Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Mylan Pharms Inc, Torrent Pharms Ltd, Astrazeneca Pharms, Astrazeneca Lp, and Horizon Pharma, and is included in twelve NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifty-six drug master file entries for esomeprazole magnesium. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: esomeprazole magnesium

Tradenames:5
Patents:20
Applicants:8
NDAs:12
Drug Master File Entries: see list56
Suppliers / Packaging: see list63
Therapeutic Class:Gastrointestinal Agents

Pharmacology for Ingredient: esomeprazole magnesium

Tentative approvals for ESOMEPRAZOLE MAGNESIUM

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, DELAYED RELEASE;ORAL20MG
<disabled><disabled>CAPSULE, DELAYED RELEASE;ORAL40MG

Clinical Trials for: esomeprazole magnesium

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

Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)
Status: Completed Condition: Heartburn; Gastroesophageal Reflux Disease

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

Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
Status: Completed Condition: Endoscopically-Proven GERD; Reflux

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

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
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 2008RXNo6,428,810*PED<disabled>Y<disabled>
Horizon Pharma
VIMOVO
esomeprazole magnesium; naproxen
TABLET, DELAYED RELEASE;ORAL022511-001Apr 30, 2010RXYes7,745,466<disabled>Y <disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001RXNo6,147,103*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: esomeprazole magnesium

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 20064,853,230*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20015,714,504*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-001Oct 20, 20065,690,960*PED<disabled>
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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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