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Details for Patent: 6,814,978

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Patent 6,814,978 protects IMODIUM A-D EZ CHEWS, PEPCID AC, and PEPCID COMPLETE, and is included in three NDAs. There has been one Paragraph IV challenge on Pepcid Complete. There are three tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Protection for PEPCID AC has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 6,814,978

Title: Process for preparing a soft tablet
Abstract:The invention relates to a process for preparing a soft tablet capable of being chewed or disintegrated in the oral cavity. The tablet is prepared by forming a tablet having a friability of less than about 2% from a mixture comprising a pharmaceutically active ingredient, an excipient in the form of a hydrate, and a water-swellable excipient, and then applying sufficient energy, preferably in the form of heat, to the tablet for a sufficient time to decrease the hardness of the tablet by at least about 20%.
Inventor(s): Bunick; Frank J. (Randolph, NJ), Luber; Joseph (Quakertown, PA)
Assignee: McNeil-PPC, Inc. (Skillman, NJ)
Application Number:09/752,601
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition; Process;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 17th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
J And J Consumer Inc
loperamide hydrochloride
TABLET, CHEWABLE;ORAL020448-001Jul 24, 1997OTCYes6,814,978Aug 26, 2021Y
J And J Consumer Inc
TABLET, CHEWABLE;ORAL020801-002Dec 17, 2007OTCYes6,814,978*PEDFeb 26, 2022Y
J And J Consumer Inc
calcium carbonate; famotidine; magnesium hydroxide
TABLET, CHEWABLE;ORAL020958-001Oct 16, 2000OTCYes6,814,978*PEDFeb 26, 2022Y
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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.