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Last Updated: September 30, 2022

Rifaximin - Generic Drug Details


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What are the generic drug sources for rifaximin and what is the scope of patent protection?

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
Wake Forest University Health SciencesPhase 2/Phase 3
Emory UniversityPhase 2/Phase 3
University of Texas Southwestern Medical CenterPhase 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 021361-002 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 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 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

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Harvard Business School
Baxter
Boehringer Ingelheim
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.