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Details for Patent: 6,979,463

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Patent 6,979,463 protects CLARINEX D 24 HOUR and is included in one NDA.

This patent has fifty-two patent family members in thirty-five countries.

Summary for Patent: 6,979,463

Title: Stable extended release oral dosage composition
Abstract:A film-coated extended release solid oral dosage composition containing a nasal decongestant, pseudoephedrine or salt thereof, e.g., pseudoephedrine sulfate in a core effective to provide a geometric maximum plasma concentration of pseudoephedrine of about 345 ng/mL to about 365 ng/mL at a time of about 7.60 hrs to about 8.40 hrs and having two or three film-coatings on the core, the second one containing an amount of the non-sedating antihistamine, desloratadine, effective to provide a geometric maximum plasma concentration of desloratadine of about 2.15 ng/mL to about 2.45 ng/mL at a time of about 4.0 hours to about 4.5 hours, and use of the composition for treating patients showing the signs and symptoms associated with allergic and/or inflammatory conditions of the skin and airway passages are disclosed.
Inventor(s): Kou; Jim H. (Basking Ridge, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:10/175,460
Patent Claim Types:
see list of patent claims
Composition; Formulation; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Not categorized
Back Citations: 48th 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
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005RXYes6,979,463► subscribeY
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Non-Orange Book Patents for Patent: 6,979,463

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
7,820,199Stable extended release oral dosage composition► 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: 6,979,463

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina027033► subscribe
Austria463240► subscribe
Australia2005203771► 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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