Friday, September 30, 2016

Xifaxan


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


XIFAXAN (rifaximin - tablet; oral)



  • Manufacturer: SALIX PHARMS

    Approval date: May 25, 2004

    Strength(s): 200MG [RLD]


  • Manufacturer: SALIX PHARMS

    Approval date: March 24, 2010

    Strength(s): 550MG [RLD]

Has a generic version of Xifaxan been approved?


No. There is currently no therapeutically equivalent version of Xifaxan available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xifaxan. 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: About generic drugs.




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.




  • Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations
    Patent 7,045,620
    Issued: May 16, 2006
    Inventor(s): Viscomi; Giuseppe C. & Campana; Manuela & Braga; Dario & Confortini; Donatella & Cannata; Vincenzo & Severini; Denis & Righi; Paolo & Rosini; Goffredo
    Assignee(s): Alfa Wassermann, S.p.A.
    Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin α and rifaximin β, and a poorly crystalline form named rifaximin γ have been discovered. These forms are useful in the production of medicinal preparations for oral and topical use and can be obtained by means of a crystallization process carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by the addition of water at a determinate temperature and for a determinate period of time. The crystallization is followed by drying carried out under controlled conditions until a specific water content is reached in the end product.
    Patent expiration dates:

    • June 19, 2024
      ✓ 
      Drug substance


    • June 19, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Polymorphic forms α, β, and γ of rifaximin
    Patent 7,612,199
    Issued: November 3, 2009
    Inventor(s): Viscomi; Guiseppe Glaudio & Campana; Manuela & Braga; Dario & Confortini; Donatella & Cannata; Vicenzo & Righi; Paolo & Rosini; Goffredo
    Assignee(s): Alfa Wassermann, S.p.A.
    Crystalline polymorphous forms of rifaximin (INN) antibiotic named rifaximin α and rifaximin β, and a poorly crystalline form named rifaximin γ, useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.
    Patent expiration dates:

    • June 19, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Polymorphic forms α, β and γ of rifaximin
    Patent 7,902,206
    Issued: March 8, 2011
    Inventor(s): Viscomi; Giuseppe Claudio & Campana; Manuela & Braga; Dario & Confortini; Donatella & Cannata; Vincenzo & Righi; Paolo & Rosini; Goffredo
    Assignee(s): Alfa Wassermann, S.p.A.
    Crystalline polymorphous forms of rifaximin (INN) antibiotic named rifaximin α and rifaximin β, and a poorly crystalline form named rifaximin γ, useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.
    Patent expiration dates:

    • June 19, 2024
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin
    Patent 7,906,542
    Issued: March 15, 2011
    Inventor(s): Viscomi; Giuseppe Claudio & Campana; Manuela & Braga; Dario & Confortini; Donatella & Cannata; Vincenzo & Righi; Paolo & Rosini; Goffredo
    Assignee(s): Alfa Wassermann, S.p.A.
    Crystalline polymorphous forms of rifaximin (INN), referred to as rifaximin α and rifaximin β, and a poorly crystalline form referred to as rifaximin γ, useful in the production of medicaments containing rifaximin for oral and topical use and obtained by means of a crystallization process carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a fixed temperature and for a fixed period of time, followed by a drying under controlled conditions until reaching a precise water content in the end product, are the object of the invention.
    Patent expiration dates:

    • June 1, 2025
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Methods of treating travelers diarrhea and hepatic encephalopathy
    Patent 7,928,115
    Issued: April 19, 2011
    Inventor(s): Forbes; William & Bortey; Enoch
    Assignee(s): Salix Pharmaceuticals, Ltd.
    Treatment of traveler's diarrhea in subjects having hepatic encephalopathy using rifaximin is disclosed.
    Patent expiration dates:

    • July 24, 2029
      ✓ 
      Patent use: METHOD OF TREATING TRAVELERS' DIARRHEA



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:
    • March 24, 2013 - NEW PRODUCT

    • March 24, 2017 - ORPHAN DRUG EXCLUSIVITY

See also...

  • Xifaxan Consumer Information (Drugs.com)
  • Xifaxan Consumer Information (Wolters Kluwer)
  • Xifaxan Consumer Information (Cerner Multum)
  • Xifaxan Advanced Consumer Information (Micromedex)
  • Xifaxan AHFS DI Monographs (ASHP)
  • Rifaximin Consumer Information (Wolters Kluwer)
  • Rifaximin Consumer Information (Cerner Multum)
  • Rifaximin Advanced Consumer Information (Micromedex)
  • Rifaximin AHFS DI Monographs (ASHP)

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