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Omeprazole magnesium - Generic Drug Details

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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 four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and forty-seven patent family members in forty countries.

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

Summary for Generic Name: omeprazole magnesium

Tradenames:3
Patents:4
Applicants:3
NDAs:4
Drug Master File Entries: see list118
Suppliers / Packaging: see list19
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: omeprazole magnesium

Tentative approvals for OMEPRAZOLE MAGNESIUM

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, DELAYED RELEASE;ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 2008RXNo5,900,424► subscribeY ► subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-002Mar 20, 2008RXYes6,428,810► subscribeY ► subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022056-001Mar 20, 2008RXNo6,428,810► 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 OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 20035,900,424► 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, 20034,853,230*PED► subscribe
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International Patent Family for Ingredient: omeprazole magnesium

Country Document Number Estimated Expiration
Norway20012222► subscribe
Spain2222754► subscribe
Denmark1131316► 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
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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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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