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Serving 500+ biopharmaceutical companies globally:

Chubb
Covington
QuintilesIMS
Julphar
Federal Trade Commission
McKesson
Fuji
Argus Health
Baxter
Deloitte

Generated: June 28, 2017

DrugPatentWatch Database Preview

PRILOSEC OTC Drug Profile

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Which patents cover Prilosec Otc, and what generic Prilosec Otc alternatives are available?

Prilosec Otc is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has forty-two patent family members in nineteen countries.

The generic ingredient in PRILOSEC OTC is omeprazole magnesium. There are one hundred and twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Summary for Tradename: PRILOSEC OTC

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list106
Clinical Trials: see list83
Patent Applications: see list5,665
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:PRILOSEC OTC at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYesYes6,428,810► Subscribe ► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYesYes6,403,616► Subscribe ► Subscribe
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Expired Patents for Tradename: PRILOSEC OTC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20035,690,960► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20035,817,338► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20034,738,974► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20034,853,230*PED► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20035,900,424► Subscribe
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Paragraph IV activity for: PRILOSEC OTC

Drugname Dosage Strength RLD Submissiondate
omeprazole magnesiumDelayed-release Tablets20 mgPrilosec OTC3/30/2012
omeprazole magnesiumDelayed-release Capsules20 mgPrilosec OTC3/19/2007

International Patent Family for Tradename: PRILOSEC OTC

Country Document Number Estimated Expiration
Brazil9915421► Subscribe
Australia1901700► Subscribe
Israel142474► Subscribe
China100503598► Subscribe
China1325300► 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: PRILOSEC OTC

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
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
11/016Ireland► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
12/048Ireland► SubscribePRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
C/GB01/006United Kingdom► SubscribePRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
Chubb
US Department of Justice
Daiichi Sankyo
Cerilliant
Farmers Insurance
Queensland Health
Cantor Fitzgerald
Moodys
Merck

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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