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Generated: November 12, 2018

DrugPatentWatch Database Preview

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 seven suppliers. There are seven patents protecting this drug and seven Paragraph IV challenges. Additional details are available on the NEXIUM profile page.

The generic ingredient in NEXIUM is esomeprazole sodium. There are seventy-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 022101
Tradename:NEXIUM
Applicant:Astrazeneca Pharms
Ingredient:esomeprazole magnesium
Patents:3
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
NEXIUM 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)
NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101 NDA AstraZeneca Pharmaceuticals LP 0186-4010 0186-4010-02 5 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4010-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 10MG BASE/PACKET
Approval Date:Feb 27, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 25, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:May 3, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Nov 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022101

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Daiichi Sankyo
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Harvard Business School
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Moodys

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