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Details for NDA: 021153

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NDA 021153 describes NEXIUM, which is a drug marketed by Astrazeneca Pharms and Astrazeneca Lp and is included in six NDAs. It is available from eleven suppliers. There are thirteen patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NEXIUM profile page.

The generic ingredient in NEXIUM is esomeprazole sodium. There are fifty-six 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 NDA: 021153

Tradename:
NEXIUM
Applicant:
Astrazeneca Pharms
Ingredient:
esomeprazole magnesium
Patents:12
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 021153

Suppliers and Packaging for NDA: 021153

Tradename Generic Name Dosage NDA Supplier National Drug Code Package Code Package
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL 021153 AstraZeneca LP 0186-5020 0186-5020-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-31)
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL 021153 AstraZeneca LP 0186-5020 0186-5020-54 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-54)
Glossary

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Feb 20, 2001TE:ABRLD:No
Patent:5,690,960*PEDPatent Expiration:May 25, 2015Product Flag?Substance Flag?Delist Request?Y
Patent:5,714,504*PEDPatent Expiration:Aug 3, 2015Product Flag?Substance Flag?Delist Request?Y
Patent:5,877,192*PEDPatent Expiration:Nov 27, 2014Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021153

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
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20015,714,504*PED<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 20014,255,431<disabled>
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 20015,690,960*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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