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Details for Patent: 6,645,988

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Patent 6,645,988 protects ZEGERID, MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE, and ZEGERID OTC, and is included in four NDAs. There have been zero Paragraph IV challenges on Zegerid OTC and Zegerid

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

Summary for Patent: 6,645,988

Title: Substituted benzimidazole dosage forms and method of using same
Abstract:The present invention relates to pharmaceutical preparations comprising substituted benzimidazole proton pump inhibitors. There is provided a liquid or solid pharmaceutical dosage form that is not enteric coated or delayed released containing a proton pump inhibitor and a Primary Essential Buffer. When the dosage form is placed in a liquid phase the Primary Essential Buffer maintains the pH of the environment at a value greater than the pKa of the proton pump inhibitor for a time sufficient to substantially avoid acid degradation of the proton pump inhibitor in the environment. Also provided is a method for treating acid-related gastrointestinal disorders by administering a solid pharmaceutical dosage form; and a kit for the preparation of a liquid oral pharmaceutical composition.
Inventor(s): Phillips; Jeffrey O. (Ashland, MO)
Assignee: Curators of the University of Missouri (Columbia, MO)
Application Number:09/901,942
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 211th percentile
Forward Citations: 4th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004RXNo6,645,988► subscribeYY
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004RXYes6,645,988► subscribeYY
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006DISCNNo6,645,988► subscribeYY SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER SYMPTOMS ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS; MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
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Non-Orange Book Patents for Patent: 6,645,988

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
6,489,346 Substituted benzimidazole dosage forms and method of using same► subscribe
6,699,885 Substituted benzimidazole dosage forms and methods 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 Patent: 6,645,988

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina038157► subscribe
Austria340574► subscribe
Australia1907100► 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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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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