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Omeprazole magnesium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for omeprazole magnesium?

Omeprazole magnesium is the generic ingredient in three branded drugs marketed by Astrazeneca Pharms, Perrigo R And D, and Dr Reddys Labs Ltd, and is included in four NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are one hundred and twenty drug master file entries for omeprazole magnesium. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: omeprazole magnesium

Tradenames:3
Patents:3
Applicants:3
NDAs:4
Drug Master File Entries: see list120
Suppliers / Packagers: see list21
Bulk Api Vendors: see list148
Clinical Trials: see list262
Patent Applications: see list6,726
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:omeprazole magnesium at DailyMed

Pharmacology for Ingredient: omeprazole magnesium

Tentative approvals for OMEPRAZOLE MAGNESIUM

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET, DELAYED RELEASE;ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
OMEPRAZOLE MAGNESIUM
omeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL078878-001Jun 5, 2009OTCNoYes► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 2008RXYesNo6,428,810► SubscribeY ► Subscribe
Perrigo R And D
OMEPRAZOLE MAGNESIUM
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL204152-001Jul 30, 2015OTCNoNo► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYesYes6,403,616► Subscribe ► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-002Mar 20, 2008RXYesYes6,428,810► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: omeprazole magnesium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 20085,690,960► Subscribe
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
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-002Mar 20, 20085,900,424► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20034,786,505*PED► Subscribe
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International Patent Family for Ingredient: omeprazole magnesium

Country Document Number Estimated Expiration
New Zealand510993► Subscribe
China100503598► Subscribe
Sweden9803772► Subscribe
Spain2222754► Subscribe
Austria244002► 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: OMEPRAZOLE MAGNESIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB11/015United 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
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
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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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