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Magnesium hydroxide; omeprazole; sodium bicarbonate - Generic Drug Details

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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.

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

There are one hundred and twenty-eight 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 list128
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD 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, 2009DISCNNo7,399,772► subscribeY ► subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006DISCNNo6,489,346► subscribeYY ► subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-002Dec 4, 2009DISCNNo6,699,885► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: magnesium hydroxide; omeprazole; sodium bicarbonate

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
RE45198Omeprazole solution and method for using same► subscribe
5,840,737 Omeprazole 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
European Patent Office1538908► subscribe
Taiwan200303220► subscribe
Japan4991432► 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
00482Netherlands► subscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
90006-4Sweden► subscribePRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
00483Netherlands► subscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
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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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