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Generated: April 25, 2017

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Esomeprazole sodium - Generic Drug Details

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What are the generic drug sources for esomeprazole sodium and what is the scope of freedom to operate?

Esomeprazole sodium
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Accord Hlthcare, Deva Holding As, Sun Pharma Global, and Astrazeneca Pharms, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are sixty-seven drug master file entries for esomeprazole sodium. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: esomeprazole sodium

Tradenames:2
Patents:1
Applicants:5
NDAs:5
Drug Master File Entries: see list67
Suppliers / Packagers: see list7
Bulk Api Vendors: see list204
Clinical Trials: see list1,031
Patent Applications: see list5,960
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:esomeprazole sodium at DailyMed

Pharmacology for Ingredient: esomeprazole sodium

Tentative approvals for ESOMEPRAZOLE SODIUM

Applicant Application No. Form Dosage
► Subscribe► SubscribeINJECTABLE;INJECTION40MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 2005APRXYesYes► Subscribe► Subscribe
Aurobindo Pharma Ltd
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS204657-002Aug 10, 2016APRXNoNo► Subscribe► Subscribe
Deva Holding As
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS207181-001Mar 6, 2017APRXNoNo► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 2005APRXYesYes► Subscribe► Subscribe
Aurobindo Pharma Ltd
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS204657-001Aug 10, 2016APRXNoNo► Subscribe► Subscribe
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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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