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Details for Patent: 8,859,510

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Patent 8,859,510 protects DIFICID and is included in one NDA. There has been one Paragraph IV challenge on Dificid.

This patent has eighty-two patent family members in twenty-two countries.

Summary for Patent: 8,859,510

Title:Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Abstract: The invention relates to novel forms of compounds displaying broad spectrum antibiotic activity, especially crystalline polymorphic forms and amorphous forms of such compounds, compositions comprising such crystalline polymorphic forms and amorphous forms of such compounds, processes for manufacture and use thereof. The compounds and compositions of the invention are useful in the pharmaceutical industry, for example, in the treatment or prevention of diseases or disorders associated with the use of antibiotics, chemotherapies, or antiviral therapies, including, but not limited to, colitis, for example, pseudo-membranous colitis; antibiotic associated diarrhea; and infections due to Clostridium difficile ("C. difficile"), Clostridium perfringens ("C. perfringens"), Staphylococcus species, for example, methicillin-resistant Staphylococcus, or Enterococcus including Vancomycin-resistant enterococci.
Inventor(s): Chiu; Yu-Hung (San Diego, CA), Che; Tessie Mary (San Diego, CA), Romero; Alex (Oakland, CA), Ichikawa; Yoshi (San Diego, CA), Shue; Youe-Kong (San Diego, CA)
Assignee: Optimer Pharmaceuticals, Inc. (Lexington, MA)
Application Number:12/523,790
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Cubist Pharms Llc
DIFICID
fidaxomicin
TABLET;ORAL201699-001May 27, 2011RXYes8,859,510► subscribe TREATMENT OF MICROBIAL INFECTIONS
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Foreign Priority and PCT Information for Patent: 8,859,510

PCT Information
PCT FiledJanuary 22, 2008PCT Application Number:PCT/US2008/000735
PCT Publication Date:July 31, 2008PCT Publication Number: WO2008/091554

Non-Orange Book Patents for Patent: 8,859,510

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
7,507,564Tiacumicin production► subscribe
7,378,508Polymorphic crystalline forms of tiacumicin B► subscribe
8,883,986Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture 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: 8,859,510

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
TaiwanI453015► subscribe
Taiwan201350114► subscribe
TaiwanI425942► 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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