Generic Xifaxan Availability

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 in the United States.

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
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    • June 19, 2024
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  • 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
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  • 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
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  • 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
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  • 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
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      Patent use: METHOD OF TREATING TRAVELERS' DIARRHEA
  • Pharmaceutical compositions comprising polymorphic forms α, β, and γ of rifaximin
    Patent 8,158,644
    Issued: April 17, 2012
    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 19, 2024
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  • Polymorphic forms α, β and γ of rifaximin
    Patent 8,158,781
    Issued: April 17, 2012
    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
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  • Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
    Patent 8,193,196
    Issued: June 5, 2012
    Inventor(s): Viscomi; Giuseppe Claudio & Campana; Manuela & Confortini; Donatella & Barbanti; Maria Miriam & Braga; Dario
    Assignee(s): Alfa Wassermann, S.p.A.
    Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin δ and rifaximin ε useful in the production of medicinal preparations 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 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:
    • September 2, 2027
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  • Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
    Patent 8,518,949
    Issued: August 27, 2013
    Assignee(s): ALFA Wassermann S.p.A.
    Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin δ and rifaximin ε useful in the production of medicinal preparations 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 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:
    • February 27, 2026
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  • Methods of treating hepatic encephalopathy
    Patent 8,642,573
    Issued: February 4, 2014
    Assignee(s): Salix Pharmaceuticals, Ltd
    The application describes treatment of hepatic encephalopathy using gastrointestinal specific antibiotics. One example of a gastrointestinal specific antibiotic is rifaximin. The instant application also provides methods for determining if a subject has a neurological condition or hepatic encephalopathy by determining the critical flicker frequency and/or the venous ammonia level of the subject at two or more time points. The invention further provides methods for treating these subjects.
    Patent expiration dates:
    • October 2, 2029
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      Patent use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
  • Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
    Patent 8,741,904
    Issued: June 3, 2014
    Assignee(s): Alfa Wassermann S.p.A.
    Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin δ and rifaximin ε useful in the production of medicinal preparations 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 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:
    • February 27, 2026
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      Patent use: THE TREATMENT OF PATIENTS WITH TRAVELERS' DIARRHEA (TD) OR THE REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
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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, 2017 -

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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