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Details for Patent: 5,658,583

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Patent 5,658,583 protects SYNERA and is included in one NDA.

This patent has fifty-three patent family members in nine countries.

Summary for Patent: 5,658,583

Title: Apparatus and methods for improved noninvasive dermal administration of pharmaceuticals
Abstract:An apparatus, product formulation, and method for improved dermal permeation of pharmaceuticals wherein the apparatus includes a thin drug formulation reservoir and a heat-generating chamber separated by a first non-permeable wall, wherein the reservoir and chamber are formed in or supported by a housing. The drug formulation reservoir houses or is capable of housing a predetermined amount of a formulation containing pharmaceutically-active agent(s). The heat-generating/temperature-regulating chamber includes a medium for generating controlled heat, preferably a chemical composition made of carbon, iron, water and/or salt which is activated upon contact with air (oxygen). The function of the heat-generating/temperature-regulating element is to heat the user's skin, rapidly bring the skin temperature to a desired and elevated narrow range and keep it in this range for sufficient time to obtain more rapid, enhanced and less variable dermal absorption of selected pharmaceutically-active agents and to obtain improved clinical effects. Structure for controlling the generation of heat is also disclosed. The apparatus may optionally include a spacing or standoff structure which spans the drug formulation reservoir between the non-permeable wall and the user's skin surface for maintaining a predetermined thickness of the drug formulation on the user's skin surface. Also, a novel product formulation which can be used with the apparatus which uses high percentage of eutectic mixture of local anesthetics to reduce the overall degradation rate of the local anesthetic compound(s) in formulations which are subject to hydrolysis.
Inventor(s): Zhang; Jie (Salt Lake City, UT), Zhang; Hao (Salt Lake City, UT)
Assignee:
Application Number:08/508,463
Patent Claim Types:
see list of patent claims
Device; Formulation; Composition; Compound; Use; Delivery;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Galen Specialty
SYNERA
lidocaine; tetracaine
PATCH;TOPICAL021623-001Jun 23, 2005RXYes5,658,583► subscribeY
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Non-Orange Book Patents for Patent: 5,658,583

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
6,284,266 Methods and apparatus for improved administration of fentanyl and sufentanil► subscribe
6,955,819 Methods and apparatus for using controlled heat to regulate transdermal and controlled release delivery of fentanyl, other analgesics, and other medical substances► subscribe
6,613,350 Electrical apparatus for heating to a desired temperature for improved administration of pharmaceutically active compounds► 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: 5,658,583

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria320233► subscribe
Austria489949► subscribe
Australia2002336585► 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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