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Serving 500+ biopharmaceutical companies globally:

UBS
Citi
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Boehringer Ingelheim
Baxter
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Cerilliant
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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021153

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NDA 021153 describes NEXIUM, which is a drug marketed by Astrazeneca Pharms and Astrazeneca Lp and is included in six NDAs. It is available from eleven suppliers. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the NEXIUM profile page.

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

Summary for NDA: 021153

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:8
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021153

Suppliers and Packaging for NDA: 021153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL 021153 NDA AstraZeneca Pharmaceuticals LP 0186-5020 0186-5020-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-31)
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL 021153 NDA AstraZeneca Pharmaceuticals LP 0186-5020 0186-5020-54 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-54)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Feb 20, 2001TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Nov 4, 2016Product Flag?Substance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Apr 9, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Apr 9, 2019Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021153

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Teva
Queensland Health
Fuji
Johnson and Johnson
Chubb
Federal Trade Commission
Cipla
US Department of Justice
Accenture
Express Scripts

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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