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Generated: May 30, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207920

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NDA 207920 describes NEXIUM 24HR, which is a drug marketed by Astrazeneca Lp and is included in two NDAs. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NEXIUM 24HR profile page.

The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are sixty-seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for NDA: 207920

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 207920

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL 207920 NDA Pfizer Consumer Healthcare 0573-2451 0573-2451-14 1 BOTTLE in 1 CARTON (0573-2451-14) > 14 TABLET in 1 BOTTLE
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL 207920 NDA Pfizer Consumer Healthcare 0573-2451 0573-2451-42 3 BOTTLE in 1 BLISTER PACK (0573-2451-42) > 14 TABLET in 1 BOTTLE

Summary for product number 01

Approval Date:Nov 23, 2015TE:RLD:Yes
Patent:5,900,424*PEDPatent Expiration:Nov 4, 2016Product Flag?Substance Flag?Delist Request?
Patent:6,369,085*PEDPatent Expiration:Nov 25, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,428,810*PEDPatent Expiration:May 3, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 207920

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Lp
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 20155,900,424*PED► Subscribe
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