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Serving leading biopharmaceutical companies globally:

US Department of Justice
Covington
Daiichi Sankyo
Novartis
AstraZeneca
Healthtrust
Farmers Insurance
Boehringer Ingelheim
Johnson and Johnson
Accenture

Generated: December 14, 2017

DrugPatentWatch Database Preview

PRILOSEC OTC Drug Profile

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Which patents cover Prilosec Otc, and what generic 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-eight patent family members in nineteen countries and five supplementary protection certificates in two countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYesYes► Subscribe► Subscribe► 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 PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Israel142629► Subscribe
Portugal1131316► Subscribe
Norway20012222► Subscribe
Canada2346988► Subscribe
New Zealand510993► Subscribe
New Zealand511169► Subscribe
Norway320056► Subscribe
European Patent Office1124539► Subscribe
China1326455► Subscribe
China100503598► 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
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
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
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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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Colorcon
McKinsey
Medtronic
Chubb
Cerilliant
Merck
US Department of Justice
Farmers Insurance

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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