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Generated: September 23, 2017

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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-two patent family members in twenty-four countries.

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

Summary for Generic Name: magnesium hydroxide; omeprazole; sodium bicarbonate

Tradenames:2
Patents:4
Applicants:1
NDAs:2
Drug Master File Entries: see list132
Clinical Trials: see list3,103
Drug Prices:see low prices
DailyMed Link:magnesium hydroxide; omeprazole; sodium bicarbonate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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;ORAL021850-001Mar 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
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-002Mar 24, 2006DISCNNoNo► Subscribe► Subscribe ► Subscribe
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
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
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;ORAL022456-001Dec 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
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;ORAL022456-002Dec 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
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;ORAL022456-001Dec 4, 2009► Subscribe► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006► 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;ORAL021850-001Mar 24, 2006► Subscribe► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009► 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.

Export unavailable in trial.
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International Patent Family for Ingredient: magnesium hydroxide; omeprazole; sodium bicarbonate

Country Document Number Estimated Expiration
Canada2594185► Subscribe
New Zealand520121► Subscribe
Austria340574► Subscribe
Eurasian Patent Organization200400966► Subscribe
European Patent Office2201952► Subscribe
Cyprus1107512► Subscribe
MexicoPA04000223► Subscribe
South Korea20040099265► Subscribe
Canada2453117► Subscribe
Israel150696► 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.

Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/006United Kingdom► SubscribePRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
00483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
00517Netherlands► SubscribePRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
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
2012000017Germany► SubscribePRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
00482Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
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
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
90006-4Sweden► SubscribePRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
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Serving 500+ biopharmaceutical companies globally:

Accenture
Merck
Julphar
Healthtrust
US Department of Justice
Federal Trade Commission
Dow
Cantor Fitzgerald
Farmers Insurance
Boehringer Ingelheim

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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