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Details for Patent: 6,375,986

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Patent 6,375,986 protects TRICOR and is included in one NDA. There have been two Paragraph IV challenges on Tricor. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has one hundred and fifty-two patent family members in twenty-six countries.

Summary for Patent: 6,375,986

Title: Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate
Abstract:Disclosed are solid dose nanoparticulate compositions comprising a poorly soluble active agent, at least one polymeric surface stabilizer, and dioctyl sodium sulfosuccinate (DOSS). The solid dose compositions exhibit superior redispersibility of the nanoparticulate composition upon administration to a mammal, such as a human or animal. The invention also describes methods of making and using such compositions.
Inventor(s): Ryde; Niels P. (Malvern, PA), Ruddy; Stephen B. (Schwenksville, PA)
Assignee: Elan Pharma International Ltd. (Clare, IE)
Application Number:09/666,539
Patent Claim Types:
see list of patent claims
Composition; Formulation; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-001Nov 5, 2004RXNo6,375,986► subscribeY ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TOTAL-C, TRIGLYCERIDES AND APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-002Nov 5, 2004RXYes6,375,986► subscribeY ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TOTAL-C, TRIGLYCERIDES AND APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
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Non-Orange Book Patents for Patent: 6,375,986

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
6,428,814 Bioadhesive nanoparticulate compositions having cationic surface stabilizers► subscribe
7,695,739In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate or nanoparticulate active agent compositions► subscribe
6,316,029 Rapidly disintegrating solid oral dosage form► 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: 6,375,986

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina040110► subscribe
Argentina072134► subscribe
Argentina072135► 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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