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Details for New Drug Application (NDA): 022101

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NDA 022101 describes NEXIUM, which is a drug marketed by Astrazeneca Pharms and Astrazeneca Lp and is included in six NDAs. It is available from thirteen suppliers. There are nine patents protecting this drug and four Paragraph IV challenges. Additional details are available on the NEXIUM profile page.

The generic ingredient in NEXIUM is esomeprazole sodium. There are sixty-six drug master file entries for this compound. Six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for NDA: 022101

Astrazeneca Pharms
esomeprazole magnesium
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022101

Suppliers and Packaging for NDA: 022101

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL 022101 NDA AstraZeneca Pharmaceuticals LP 0186-4010 0186-4010-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4010-01)

Summary for product number 001

Approval Date:Feb 27, 2008TE:RLD:No
Patent:5,714,504*PEDPatent Expiration:Aug 3, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,900,424*PEDPatent Expiration:Nov 4, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,369,085*PEDPatent Expiration:Nov 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022101

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 20085,900,424*PED► subscribe
Astrazeneca Pharms
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 20085,690,960*PED► subscribe
Astrazeneca Pharms
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 20085,714,504*PED► 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.