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Last Updated: September 25, 2022

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-seven patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and six patent family members in thirty-nine 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® Generic Entry Outlook for Xifaxan

Xifaxan was eligible for patent challenges on May 25, 2008.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2, 2027. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $478mm indicating the motivation for generic entry (peak sales were $2.0bn in 2016).

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for XIFAXAN
Drug Prices for XIFAXAN

See drug prices for XIFAXAN

Drug Sales Revenue Trends for XIFAXAN

See drug sales revenues for XIFAXAN

DrugPatentWatch® Estimated Generic Entry Opportunity Date for XIFAXAN
Generic Entry Dates for XIFAXAN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for XIFAXAN*:
Constraining patent/regulatory exclusivity:
NDA:
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 XIFAXAN

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

SponsorPhase
MetroHealth Medical CenterPhase 3
Ronnie Fass, MDPhase 3
Cedars-Sinai Medical CenterPhase 1/Phase 2

See all XIFAXAN clinical trials

Pharmacology for XIFAXAN
Paragraph IV (Patent) Challenges for XIFAXAN
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 XIFAXAN

XIFAXAN is protected by thirty-seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XIFAXAN is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XIFAXAN

Methods of treating hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

Methods of treating hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN A SUBJECT'S RISK OF EXPERIENCING A BREAKTHROUGH OVERT HEPATIC ENCEPHALOPATHY (HE) EPISODE

Methods for treating irritable bowel syndrome (IBS)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER AND SYMPTOMS THEREOF

Methods for treating irritable bowel syndrome (IBS)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRAVELERS' DIARRHEA (TD) CAUSED BY NONINVASIVE STRAINS OF ESCHERIA COLI IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE IN ADULTS

Methods of treating hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN A SUBJECT'S RISK OF EXPERIENCING A BREAKTHROUGH OVERT HEPATIC ENCEPHALOPATHY (HE) EPISODE

Methods for treating irritable bowel syndrome (IBS)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER

Methods for treating irritable bowel syndrome (IBS)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER AND SYMPTOMS THEREOF

Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of polymorphic forms of rifaximin for medical preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.

Use of polymorphic forms of rifaximin for medical preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.

Methods of treating travelers diarrhea and hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TRAVELERS' DIARRHEA

Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.

Methods for treating diarrhea-associated irritable bowel syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.

Methods for treating diarrhea-associated irritable bowel syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: THE TREATMENT OF PATIENTS WITH TRAVELERS' DIARRHEA (TD) OR THE REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.

Methods of treating traveler's diarrhea and hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH HEPATIC ENCEPHALOPATHY (HE)

Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating traveler's diarrhea and hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

Methods of treating hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

Methods of treating traveler's diarrhea and hepatic encephalopathy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) IN ADULTS

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 021361-002 Mar 24, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 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 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 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 XIFAXAN

When does loss-of-exclusivity occur for XIFAXAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06222312
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0608073
Estimated Expiration: See Plans and Pricing

Canada

Patent: 94789
Estimated Expiration: See Plans and Pricing

China

Patent: 00077
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0070433
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 98630
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 98630
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 96396
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4694
Estimated Expiration: See Plans and Pricing

Japan

Patent: 37825
Estimated Expiration: See Plans and Pricing

Patent: 08531623
Estimated Expiration: See Plans and Pricing

Patent: 13216710
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07010742
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 81
Estimated Expiration: See Plans and Pricing

Patent: 070265
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 272
Estimated Expiration: See Plans and Pricing

Patent: 4408
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 345
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6737
Estimated Expiration: See Plans and Pricing

Norway

Patent: 2197
Estimated Expiration: See Plans and Pricing

Patent: 074988
Estimated Expiration: See Plans and Pricing

Poland

Patent: 98630
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 98630
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 97985
Estimated Expiration: See Plans and Pricing

Patent: 07136430
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 570
Estimated Expiration: See Plans and Pricing

Patent: 070364
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 98630
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0707397
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0885755
Estimated Expiration: See Plans and Pricing

Patent: 060096242
Estimated Expiration: See Plans and Pricing

Spain

Patent: 22895
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 07250
Estimated Expiration: See Plans and Pricing

Patent: 07292
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 809
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XIFAXAN around the world.

Country Patent Number Title Estimated Expiration
Moldova, Republic of 20070265 Forme polimorfe de rifaximina, procedeu deobtinere a lor si utilizarea lor la fabricarea preparatelor medicamentoase (Polymorphous forms of rifaximin, process for their production and use thereof for production of medicinal preparations) See Plans and Pricing
Germany 602004006367 Polymorphe Form von Rifaximin als Antibiotikum See Plans and Pricing
Japan 2008531623 See Plans and Pricing
Argentina 081991 FORMA POLIMORFICA b DE RIFAXIMINA, PROCESOS PARA SU PRODUCCION Y SUS COMPOSICIONES FARMACEUTICAS See Plans and Pricing
European Patent Office 1557421 Forme polymorphe du rifaximin comme antibiotique (Polymorphous form of rifaximin as antibiotic) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
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McKesson
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Colorcon
Boehringer Ingelheim

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.