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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Chinese Patent Office
US Department of Justice
UBS
Chubb
Express Scripts
Cipla
Fuji
Colorcon

Generated: December 17, 2017

DrugPatentWatch Database Preview

PRILOSEC Drug Profile

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When do Prilosec patents expire, and when can generic versions of Prilosec launch?

Prilosec is a drug marketed by Astrazeneca Pharms and Covis Pharma Bv and is included in three NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has forty-nine patent family members in nineteen countries and five supplementary protection certificates in two countries.

The generic ingredient in PRILOSEC 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 Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995DISCNYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989DISCNYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995DISCNYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998DISCNYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989DISCNYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsPRILOSEC OTComeprazole magnesiumTABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995DISCNYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995DISCNYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989DISCNYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989DISCNYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: PRILOSEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995► Subscribe► Subscribe
Covis Pharma BvPRILOSEComeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 2008► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989► Subscribe► Subscribe
Covis Pharma BvPRILOSEComeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL022056-002Mar 20, 2008► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989► Subscribe► Subscribe
Covis Pharma BvPRILOSEComeprazole magnesiumFOR SUSPENSION, DELAYED RELEASE;ORAL022056-002Mar 20, 2008► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for PRILOSEC

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

Country Document Number Estimated Expiration
Spain2201837► Subscribe
Austria244002► Subscribe
Norway20012222► Subscribe
South Africa200101140► Subscribe
China1160062► Subscribe
Germany69909316► Subscribe
Hong Kong1034510► Subscribe
Norway20010677► Subscribe
Denmark1124539► Subscribe
Japan2003516985► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB01/006United Kingdom► SubscribePRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Citi
US Army
Chinese Patent Office
UBS
Healthtrust
Cantor Fitzgerald
Deloitte
Moodys

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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