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Details for Patent: 7,863,249

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Patent 7,863,249 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: 7,863,249

Title:Macrolide 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 (San Diego, CA), Ichikawa; Yoshi (San Diego, CA), Shue; Youe-Kong (Carlsbad, CA)
Assignee: Optimer Pharmaceuticals, Inc. (San Diego, CA)
Application Number:12/101,552
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 9th percentile
Forward Citations: 1st 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, 2011RXYes7,863,249► subscribeYY
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Non-Orange Book Patents for Patent: 7,863,249

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
8,883,986Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof► subscribe
8,518,899Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof► subscribe
7,507,564Tiacumicin production► 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: 7,863,249

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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