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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Queensland Health
Chubb
US Department of Justice
Teva
Cerilliant
Fuji
Chinese Patent Office
Julphar
Daiichi Sankyo

Generated: November 24, 2017

DrugPatentWatch Database Preview

Magnesium hydroxide; omeprazole; sodium bicarbonate - Generic Drug Details

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What are the generic drug sources for magnesium hydroxide; omeprazole; sodium bicarbonate and what is the scope of magnesium hydroxide; omeprazole; sodium bicarbonate patent protection?

Magnesium hydroxide; omeprazole; sodium bicarbonate
is the generic ingredient in two branded drugs marketed by Santarus and is included in two NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Magnesium hydroxide; omeprazole; sodium bicarbonate has sixty-four patent family members in twenty-four countries and twelve supplementary protection certificates in seven countries.

There are one hundred and thirty-six drug master file entries for magnesium hydroxide; omeprazole; sodium bicarbonate.

Summary for magnesium hydroxide; omeprazole; sodium bicarbonate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 2006DISCNNoNo► Subscribe► Subscribe ► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006DISCNNoNo► Subscribe► Subscribe ► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-002Dec 4, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-002Dec 4, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-002Dec 4, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 2006DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-002Dec 4, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: magnesium hydroxide; omeprazole; sodium bicarbonate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009► Subscribe► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006► Subscribe► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 2006► Subscribe► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006► Subscribe► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 2006► Subscribe► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009► Subscribe► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009► Subscribe► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-002Dec 4, 2009► Subscribe► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-002Dec 4, 2009► Subscribe► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: magnesium hydroxide; omeprazole; sodium bicarbonate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,840,737 Omeprazole solution and method for using same► Subscribe
RE45198Omeprazole solution and method for using same► Subscribe
6,780,882 Substituted benzimidazole dosage forms and method of using same► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: magnesium hydroxide; omeprazole; sodium bicarbonate

Country Document Number Estimated Expiration
Japan4991432► Subscribe
China1735344► Subscribe
South Africa200205512► Subscribe
Denmark1246622► Subscribe
Japan5944943► Subscribe
South Africa200400241► Subscribe
Spain2275650► Subscribe
World Intellectual Property Organization (WIPO)03009846► Subscribe
European Patent Office1246622► Subscribe
Australia3276701► 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: MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90006-4Sweden► SubscribePRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
2012 00035Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
2012000017Germany► SubscribePRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
00615Netherlands► SubscribePRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220
00483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
2012000051Germany► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
0483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
00517Netherlands► SubscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Argus Health
Mallinckrodt
Julphar
Federal Trade Commission
Healthtrust
Accenture
Cerilliant
Dow

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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