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Serving leading biopharmaceutical companies globally:

Chubb
US Army
Deloitte
Baxter
Argus Health
Cerilliant
Farmers Insurance
Merck
QuintilesIMS
McKinsey

Generated: October 23, 2017

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 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-nine drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for NDA: 204655

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Gastrointestinal Agents
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 0573-2450-14 1 BOTTLE in 1 CARTON (0573-2450-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL 204655 NDA Wyeth Consumer Healthcare LLC 0573-2450 0573-2450-15 1 BOTTLE in 1 BLISTER PACK (0573-2450-15) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Mar 28, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 28, 2017
Regulatory Exclusivity Use:RX TO OTC SWITCH OR OTC USE
Patent:► SubscribePatent Expiration:Nov 4, 2016Product Flag?Substance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Nov 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book 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;ORAL204655-001Mar 28, 2014► Subscribe► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014► Subscribe► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014► Subscribe► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014► Subscribe► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Mallinckrodt
Teva
Cipla
Queensland Health
Chinese Patent Office
US Army
Novartis
Accenture

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.

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