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Express Scripts
Boehringer Ingelheim

Last Updated: January 27, 2023

Details for Patent: 7,378,508

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Which drugs does patent 7,378,508 protect, and when does it expire?

Patent 7,378,508 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-five patent family members in twenty-eight countries.

Summary for Patent: 7,378,508
Title:Polymorphic crystalline forms of tiacumicin B
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:11/831,886
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,378,508
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition;

Drugs Protected by US Patent 7,378,508

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 7,378,508

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 516024 See Plans and Pricing
Australia 2003251902 See Plans and Pricing
Australia 2005327308 See Plans and Pricing
Australia 2006304868 See Plans and Pricing
Australia 2008209580 See Plans and Pricing
Belgium 2015C017 See Plans and Pricing
Brazil PI0511119 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

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 verification 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.