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ZEGERID Drug Profile

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Zegerid is a drug marketed by Santarus Inc, Santarus, and Bayer Healthcare Llc. and is included in five NDAs. It is available from four suppliers. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has sixty patent family members in twenty-three countries.

The generic ingredient in ZEGERID is magnesium hydroxide; omeprazole; sodium bicarbonate. There are one hundred and twenty-eight drug master file entries for this compound. Additional details are available on the magnesium hydroxide; omeprazole; sodium bicarbonate profile page.

Summary for Tradename: ZEGERID

Patents:7
Applicants:3
NDAs:5
Suppliers / Packagers: see list4
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: ZEGERID

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
CAPSULE;ORAL022281-001Dec 1, 2009OTCYes7,399,772► subscribe ► subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 2006DISCNNo6,645,988► subscribeYY ► subscribe
Bayer Healthcare Llc
ZEGERID OTC
omeprazole; sodium bicarbonate
CAPSULE;ORAL022281-001Dec 1, 2009OTCYes6,699,885► subscribeYY ► subscribe
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Expired Patents for Tradename: ZEGERID

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 20067,399,772► subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-002Feb 27, 20066,645,988► subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 20066,699,885► subscribe
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Paragraph IV activity for: ZEGERID

Drugname Dosage Strength RLD Submissiondate
omeprazole and sodium bicarbonateCapsules20 mg/1100 mgZegerid OTC4/20/2010
omeprazole and sodium bicarbonatePowder for Oral Suspension20mg/1680mg per packetZegerid11/13/2007
omeprazole and sodium bicarbonatePowder for Oral Suspension40 mg/1680 mg per packetZegerid8/24/2007
omeprazole and sodium bicarbonateCapsules20 mg/1100 mg and 40 mg/1100 mgZegerid4/30/2007

International Patent Family for Tradename: ZEGERID

Country Document Number Estimated Expiration
New Zealand520121► subscribe
Japan2003519656► subscribe
Poland367272► 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: ZEGERID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00482Netherlands► subscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 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
00517Netherlands► subscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
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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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