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PRILOSEC Drug Profile

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Which patents cover Prilosec, and what substitute generic drugs are available?

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

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

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

Summary for Tradename: PRILOSEC

Patents:5
Applicants:1
NDAs:3
Suppliers / Packagers: see list3
Bulk Api Vendors: see list106
Clinical Trials: see list6
Patent Applications: see list5,851
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:PRILOSEC at DailyMed

Pharmacology for Tradename: PRILOSEC

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995DISCNYesNo6,147,103*PED► SubscribeY► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989DISCNYesNo6,166,213*PED► SubscribeY► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995DISCNYesNo6,191,148*PED► SubscribeY► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998DISCNYesNo6,191,148*PED► SubscribeY► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989DISCNYesNo6,191,148*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: PRILOSEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 19894,255,431*PED► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 19984,255,431*PED► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 19895,629,305*PED► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 19894,636,499*PED► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 19955,599,794*PED► Subscribe
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Paragraph IV activity 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
New Zealand510993► Subscribe
Sweden9803772► Subscribe
Australia1434600► Subscribe
Australia764642► Subscribe
European Patent Office1124539► 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
C/GB11/015United 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
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
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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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