XIFAXAN Drug Patent Profile
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Which patents cover Xifaxan, and what generic alternatives are available?
Xifaxan is a drug marketed by Salix Pharms and is included in one NDA. There are twenty patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and twenty-four patent family members in thirty-one countries.
The generic ingredient in XIFAXAN is rifaximin. There are fourteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the rifaximin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Xifaxan
A generic version of XIFAXAN was approved as rifaximin by ACTAVIS LABS FL INC on March 19th, 2026.
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Questions you can ask:
- What is the 5 year forecast for XIFAXAN?
- What are the global sales for XIFAXAN?
- What is Average Wholesale Price for XIFAXAN?
Summary for XIFAXAN
| International Patents: | 124 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 41 |
| Drug Prices: | Drug price information for XIFAXAN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XIFAXAN |
| What excipients (inactive ingredients) are in XIFAXAN? | XIFAXAN excipients list |
| DailyMed Link: | XIFAXAN at DailyMed |
Recent Clinical Trials for XIFAXAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bausch Health Americas, Inc. | PHASE4 |
| Pomeranian Medical University Szczecin | NA |
| Ronnie Fass, MD | Phase 3 |
Pharmacology for XIFAXAN
| Drug Class | Rifamycin Antibacterial |
US Patents and Regulatory Information for XIFAXAN
XIFAXAN is protected by thirty-one US patents.
| 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 | AB | RX | Yes | Yes | 8,518,949 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | AB | RX | Yes | Yes | 9,271,968 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | AB | RX | Yes | Yes | 11,779,571 | ⤷ Start Trial | ⤷ Start Trial | |||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | RX | Yes | Yes | 7,928,115 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | AB | RX | Yes | Yes | 10,335,397 | ⤷ Start Trial | ⤷ Start Trial | |||
| >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 XIFAXAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | 8,158,644 | ⤷ Start Trial |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | 10,703,763 | ⤷ Start Trial |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | 8,741,904 | ⤷ Start Trial |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-002 | Mar 24, 2010 | 8,835,452 | ⤷ Start Trial |
| Salix Pharms | XIFAXAN | rifaximin | TABLET;ORAL | 021361-001 | May 25, 2004 | 8,741,904 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XIFAXAN
See the table below for patents covering XIFAXAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2009298389 | Methods of treating hepatic encephalopathy | ⤷ Start Trial |
| Australia | 2010260089 | Modulation of systemic exposure to rifaximin | ⤷ Start Trial |
| Australia | 2010271070 | Methods of treating hepatic encephalopathy | ⤷ Start Trial |
| Brazil | PI0920465 | metodo de tratamento de encefalopatia hepática | ⤷ Start Trial |
| Brazil | PI1010028 | métodos de tratamento de encefalopatia hepática | ⤷ Start Trial |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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