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Last Updated: September 27, 2020

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Details for Patent: 8,859,510

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Which drugs does patent 8,859,510 protect, and when does it expire?

Patent 8,859,510 protects DIFICID and is included in two NDAs.

Protection for DIFICID has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and twenty-two patent family members in twenty-eight 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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,859,510
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;

Drugs Protected by US Patent 8,859,510

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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

International Family Members for US Patent 8,859,510

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 516024   Start Trial
Australia 2003251902   Start Trial
Australia 2005327308   Start Trial
Australia 2006304868   Start Trial
Australia 2008209580   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Baxter
McKinsey
Dow
Boehringer Ingelheim

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