Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204655

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NDA 204655 describes NEXIUM 24HR, which is a drug marketed by Astrazeneca Lp and is included in two NDAs. It is available from two suppliers. There is one patent 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 seventy-four drug master file entries for this compound. Eighty-nine suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 204655
Tradename:NEXIUM 24HR
Applicant:Astrazeneca Lp
Ingredient:esomeprazole magnesium
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204655
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655 NDA Wyeth Consumer Healthcare LLC 0573-2450 0573-2450-02 1 BLISTER PACK in 1 CARTON (0573-2450-02) > 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655 NDA Wyeth Consumer Healthcare LLC 0573-2450 0573-2450-14 1 BOTTLE in 1 CARTON (0573-2450-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 204655
Tradename Dosage Ingredient NDA Submissiondate
NEXIUM 24HR CAPSULE, DELAYED RELEASE;ORAL esomeprazole magnesium 204655 2014-04-24

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Mar 28, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 3, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 204655

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014   Start Trial   Start Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014   Start Trial   Start Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014   Start Trial   Start Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014   Start Trial   Start Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014   Start Trial   Start Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014   Start Trial   Start Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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