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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
US Department of Justice
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Fuji
Cantor Fitzgerald
Citi
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Moodys
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Generated: June 27, 2017

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Omeprazole magnesium - Generic Drug Details

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What are the generic drug sources for omeprazole magnesium and what is the scope of omeprazole magnesium freedom to operate?

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

Omeprazole magnesium has forty-two patent family members in nineteen countries.

There are one hundred and twenty-one drug master file entries for omeprazole magnesium. Twenty 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:4
NDAs:4
Drug Master File Entries: see list121
Suppliers / Packagers: see list20
Bulk Api Vendors: see list148
Clinical Trials: see list675
Patent Applications: see list5,345
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. Strength Dosage Form
► Subscribe► Subscribe20MGTABLET, DELAYED RELEASE;ORAL
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, 2003OTCYesYes6,403,616► Subscribe ► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003OTCYesYes6,428,810► Subscribe ► Subscribe
Covis Pharma Bv
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 2008RXYesNo6,428,810► SubscribeY ► Subscribe
Covis Pharma Bv
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-002Mar 20, 2008RXYesYes6,428,810► SubscribeY ► Subscribe
Perrigo R And D
OMEPRAZOLE MAGNESIUM
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL204152-001Jul 30, 2015OTCNoNo► Subscribe► 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
Covis Pharma Bv
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
Covis Pharma Bv
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, 20034,738,974► Subscribe
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International Patent Family for Ingredient: omeprazole magnesium

Country Document Number Estimated Expiration
Sweden9803952► Subscribe
Norway20012222► Subscribe
Austria244002► Subscribe
Australia770633► Subscribe
Hong Kong1038920► 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
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Deloitte
McKesson
Daiichi Sankyo
Express Scripts
Fish and Richardson
Chubb
McKinsey
Colorcon
Cantor Fitzgerald
Federal Trade Commission

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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