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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 021957


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NDA 021957 describes NEXIUM, which is a drug marketed by Astrazeneca Pharms and Astrazeneca Lp and is included in six NDAs. It is available from two suppliers. There is one patent 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-four 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 021957
Tradename:NEXIUM
Applicant:Astrazeneca Pharms
Ingredient:esomeprazole magnesium
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021957
Suppliers and Packaging for NDA: 021957
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957 NDA AstraZeneca Pharmaceuticals LP 0186-4020 0186-4020-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4020-01)
NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957 NDA AstraZeneca Pharmaceuticals LP 0186-4025 0186-4025-01 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4025-01)
Paragraph IV (Patent) Challenges for 021957
Tradename Dosage Ingredient NDA Submissiondate
NEXIUM FOR SUSPENSION, DELAYED RELEASE;ORAL esomeprazole magnesium 021957 2013-08-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 20MG BASE/PACKET
Approval Date:Oct 20, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 3, 2020Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 40MG BASE/PACKET
Approval Date:Oct 20, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:May 3, 2020Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, DELAYED RELEASE;ORALStrengthEQ 2.5MG BASE/PACKET
Approval Date:Dec 15, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 3, 2020Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021957

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Baxter

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