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Details for Patent: 9,358,297

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Patent 9,358,297 protects NOXAFIL and is included in one NDA. There have been three Paragraph IV challenges on Noxafil.

This patent has nine patent family members in nine countries.

Summary for Patent: 9,358,297

Title:Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin
Abstract: The present invention relates to aqueous solutions useful as pharmaceutical compositions of posaconazole for intravenous administration. These compositions include a solubilizing agent, such as a modified .beta.-cyclodextrin in an acidified solution, which can also include a chelating agent such as disodium edetate (EDTA). In clinical trials, a 200 mg posaconazole dose of the selected composition was found to achieve acceptable pharmacokinetic properties.
Inventor(s): Heimbecher; Susan K. (Morris Plains, NJ), Monteith; David (Pittstown, NJ), Pipkin; James D. (Lawrence, KS)
Assignee: Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:14/668,683
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
Merck Sharp Dohme
NOXAFIL
posaconazole
SOLUTION;IV (INFUSION)205596-001Mar 13, 2014RXYes9,358,297► subscribeY PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
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Non-Orange Book Patents for Patent: 9,358,297

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
9,023,790Posaconazole intravenous solution formulations stabilized by substituted .beta.-cyclodextrin► 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: 9,358,297

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Russian Federation2013103724► subscribe
Mexico2012015168► subscribe
South Korea20130114603► 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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