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Last Updated: November 30, 2022

Rifaximin - Generic Drug Details


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What are the generic sources for rifaximin and what is the scope of freedom to operate?

Rifaximin is the generic ingredient in one branded drug marketed by Salix Pharms and is included in one NDA. There are twenty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rifaximin has two hundred and six patent family members in thirty-nine countries.

There are fourteen drug master file entries for rifaximin. Three suppliers are listed for this compound.

Recent Clinical Trials for rifaximin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of MinnesotaPhase 2/Phase 3
Wake Forest University Health SciencesPhase 2/Phase 3
Emory UniversityPhase 2/Phase 3

See all rifaximin clinical trials

Pharmacology for rifaximin
Paragraph IV (Patent) Challenges for RIFAXIMIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
XIFAXAN Tablets rifaximin 200 mg 021361 1 2019-01-28
XIFAXAN Tablets rifaximin 550 mg 021361 1 2015-12-18

US Patents and Regulatory Information for rifaximin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 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. >Exclusivity Expiration

International Patents for rifaximin

Country Patent Number Title Estimated Expiration
China 102548408 Methods of treating hepatic encephalopathy See Plans and Pricing
Russian Federation 2540513 СПОСОБЫ ЛЕЧЕНИЯ ПЕЧЕНОЧНОЙ ЭНЦЕФАЛОПАТИИ (METHOD OF TREATING HEPATIC ENCEPHALOPATHY) See Plans and Pricing
Poland 2252148 See Plans and Pricing
Hong Kong 1096396 NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL PREPARATIONS See Plans and Pricing
Japan 2011046738 POLYMORPHS OF RIFAXIMIN, METHODS FOR PRODUCTION THEREOF, AND USE THEREOF IN PHARMACEUTICAL PREPARATION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Dow
Merck
Medtronic
McKesson

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