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Last Updated: November 8, 2024

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-nine 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 sixteen patent family members in forty countries.

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

Summary for rifaximin
Recent Clinical Trials for rifaximin

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

SponsorPhase
Tata Memorial CentrePhase 2
Al-Azhar UniversityPhase 2
Xin ZengN/A

See all rifaximin clinical trials

Generic filers with tentative approvals for RIFAXIMIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up550MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up550MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

Expired US Patents for rifaximin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 ⤷  Sign Up ⤷  Sign Up
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 ⤷  Sign Up ⤷  Sign Up
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 ⤷  Sign Up ⤷  Sign Up
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 ⤷  Sign Up ⤷  Sign Up
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 ⤷  Sign Up ⤷  Sign Up
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-001 May 25, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for rifaximin

Country Patent Number Title Estimated Expiration
Japan 2011046738 POLYMORPHS OF RIFAXIMIN, METHODS FOR PRODUCTION THEREOF, AND USE THEREOF IN PHARMACEUTICAL PREPARATION ⤷  Sign Up
Slovenia 3628319 ⤷  Sign Up
Hong Kong 1092150 POLYMORPHOUS FORMS OF RIFAXIMIN AS ANTIBIOTICS ⤷  Sign Up
South Korea 20050043589 POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN MEDICINAL PREPARATIONS ⤷  Sign Up
Slovenia 2350096 ⤷  Sign Up
Canada 2594789 NOUVELLES FORMES POLYMORPHES DE RIFAXIMINE, LEURS PROCEDES DE PREPARATION ET LEUR UTILISATION EN MEDECINE (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.