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Last Updated: July 18, 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 thirteen 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.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for rifaximin
Generic Entry Dates for rifaximin*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for rifaximin*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 Up200MGTABLET;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 021361-001 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 021361-001 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 021361-001 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
Russian Federation 2007136430 НОВЫЕ ПОЛИМОРФНЫЕ ФОРМЫ РИФАКСИМИНА, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В ЛЕКАРСТВЕННЫХ ПРЕПАРАТАХ ⤷  Sign Up
Australia 2009219240 Methods for treating bowel diseases ⤷  Sign Up
Denmark 2350096 ⤷  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.