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NEXIUM 24HR Drug Profile

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Nexium 24hr is a drug marketed by Astrazeneca Lp and is included in two NDAs. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixteen patent family members in forty-eight countries.

The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are sixty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esomeprazole magnesium profile page.

Summary for Tradename: NEXIUM 24HR

Patents:5
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 2015OTCYes5,900,424*PED► subscribeY► subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYes7,411,070*PED► subscribeY► subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 2015OTCYes6,369,085*PED► subscribeY► subscribe
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Expired Patents for Tradename: NEXIUM 24HR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20145,877,192*PED► subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 20145,900,424*PED► subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
TABLET, DELAYED RELEASE;ORAL207920-01Nov 23, 20155,900,424*PED► subscribe
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Paragraph IV activity for: NEXIUM 24HR

Drugname Dosage Strength RLD Submissiondate
esomeprazoleDelayed-release Tablets20 mgNexium 24HR (OTC)9/9/2016

Non-Orange Book Patents for Tradename: NEXIUM 24HR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,693,818 Process for preparing pure salts of pyridinylmethyl-sulfinyl-1H-benzimidazole► subscribe
6,677,455 Potassium salt of S-omeprazole► subscribe
7,745,466Form of S-omeprazole► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: NEXIUM 24HR

Country Document Number Estimated Expiration
Germany69814069► subscribe
Germany69829511► subscribe
Indonesia29306► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NEXIUM 24HR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/015United Kingdom► subscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
870Luxembourg► subscribe
90006-4Sweden► subscribePRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
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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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