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Details for Patent: 7,682,628

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Patent 7,682,628 protects INTERMEZZO and is included in one NDA. There has been one Paragraph IV challenge on Intermezzo.

This patent has nineteen patent family members in twelve countries.

Summary for Patent: 7,682,628

Title:Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
Abstract: The present invention provides novel compositions for the delivery of a hypnotic agent across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 7.8, thereby facilitating the substantially complete conversion of the hypnotic agent from its ionized to its un-ionized form. As a result, the dose of hypnotic agent is rapidly and efficiently absorbed by the oral mucosa with surprisingly low inter-subject variability. Furthermore, delivery of the hypnotic agent across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating sleep disorders such as insomnia are also provided.
Inventor(s): Singh; Nikhilesh N. (Mill Valley, CA)
Assignee: Transcept Pharmaceuticals, Inc. (Pt. Richmond, CA)
Application Number:11/833,323
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 74th percentile
Forward Citations: 2nd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Purdue Pharma
INTERMEZZO
zolpidem tartrate
TABLET;SUBLINGUAL022328-001Nov 23, 2011RXNo7,682,628► subscribe METHOD FOR TREATING INSOMNIA
Purdue Pharma
INTERMEZZO
zolpidem tartrate
TABLET;SUBLINGUAL022328-002Nov 23, 2011RXYes7,682,628► subscribe METHOD FOR TREATING INSOMNIA
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Non-Orange Book Patents for Patent: 7,682,628

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
7,658,945Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof► 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: 7,682,628

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
South Korea20130116378► subscribe
South Korea20140104986► subscribe
South Korea20150038745► 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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