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Generic Dificid Availability

Last updated on Sep 8, 2021.

Dificid is a brand name of fidaxomicin, approved by the FDA in the following formulation(s):

DIFICID (fidaxomicin - for suspension;oral)

  • Manufacturer: CUBIST PHARMS LLC
    Approval date: January 24, 2020
    Strength(s): 40MG/ML [RLD]

DIFICID (fidaxomicin - tablet;oral)

  • Manufacturer: CUBIST PHARMS LLC
    Approval date: May 27, 2011
    Strength(s): 200MG [RLD]

Has a generic version of Dificid been approved?

No. There is currently no therapeutically equivalent version of Dificid available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dificid. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Polymorphic crystalline forms of tiacumicin B
    Patent 7,378,508
    Issued: May 27, 2008
    Inventor(s): Chiu; Yu-Hung & Che; Tessie Mary & Romero; Alex & Ichikawa; Yoshi & Shue; Youe-Kong
    Assignee(s): Optimer Pharmaceuticals, Inc.

    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.

    Patent expiration dates:

    • July 31, 2027
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      Drug substance
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      Drug product
    • January 31, 2028
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      Pediatric exclusivity
  • Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
    Patent 7,863,249
    Issued: January 4, 2011
    Inventor(s): Chiu; Yu-Hung & Che; Tessie Mary & Romero; Alex & Ichikawa; Yoshi & Shue; Youe-Kong
    Assignee(s): Optimer Pharmaceuticals, Inc.

    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.

    Patent expiration dates:

    • July 31, 2027
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      Drug product
    • July 31, 2027
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      Drug substance
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      Drug product
    • January 31, 2028
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      Pediatric exclusivity
  • 18-membered macrocycles and analogs thereof
    Patent 7,906,489
    Issued: March 15, 2011
    Inventor(s): Shue; Youe-Kong & Hwang; Chan-Kou & Chiu; Yu-Hung & Romero; Alex & Babakhani; Farah & Sears; Pamela & Okumu; Franklin
    Assignee(s): Optimer Pharmaceuticals, Inc.

    The present invention relates generally to the 18-membered macrocyclic antimicrobial agents called Tiacumicins, specifically, OPT-80 (which is composed almost entirely of the R-Tiacumicin B), pharmaceutical compositions comprising OPT-80, and methods using OPT-80. In particular, this compound is a potent drug for the treatment of bacterial infections, specifically C. difficile infections.

    Patent expiration dates:

    • March 4, 2027
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      Patent use: TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER
    • March 4, 2027
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      Patent use: TREATMENT OF MICROBIAL INFECTIONS
    • September 4, 2027
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      Pediatric exclusivity
  • 18-membered macrocycles and analogs thereof
    Patent 8,586,551
    Issued: November 19, 2013
    Assignee(s): Optimer Pharmaceuticals, Inc.

    The present invention relates generally to the 18-membered macrocyclic antimicrobial agents called Tiacumicins, specifically, OPT-80 (which is composed almost entirely of the R-Tiacumicin B), pharmaceutical compositions comprising OPT-80, and methods using OPT-80. In particular, this compound is a potent drug for the treatment of bacterial infections, specifically C. difficile infections.

    Patent expiration dates:

    • July 23, 2023
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      Drug substance
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      Drug product
    • July 15, 2023
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      Drug substance
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      Drug product
    • January 23, 2024
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      Pediatric exclusivity
    • January 15, 2024
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      Pediatric exclusivity
  • Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
    Patent 8,859,510
    Issued: October 14, 2014
    Assignee(s): Optimer Pharmaceuticals, Inc.

    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.

    Patent expiration dates:

    • July 31, 2027
      ✓ 
      Patent use: TREATMENT OF CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) IN PATIENTS FROM 6 MONTHS OF AGE AND OLDER
    • July 31, 2027
      ✓ 
      Patent use: TREATMENT OF MICROBIAL INFECTIONS
    • January 31, 2028
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      Pediatric exclusivity
  • Patent 9,808,530

    Patent expiration dates:

    • May 28, 2034
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      Drug product
    • November 28, 2034
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      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • January 24, 2023 - NEW PATIENT POPULATION
    • January 24, 2023 - NEW PRODUCT
    • July 24, 2023 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.