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

This drug has two hundred and sixteen patent family members in forty 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.

There have been eight 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.

There are two tentative approvals for the generic drug (rifaximin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for XIFAXAN

International Patents:	216
US Patents:	29
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	39
Patent Applications:	4,693
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

Drug patent expirations by year for XIFAXAN

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XIFAXAN

Generic Entry Dates for XIFAXAN^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 021361 Dosage: TABLET;ORAL
Generic Entry Dates for XIFAXAN^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 022554 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

Sponsor	Phase
MetroHealth Medical Center	Phase 3
Ronnie Fass, MD	Phase 3
Cedars-Sinai Medical Center	Phase 1/Phase 2

See all XIFAXAN clinical trials

Pharmacology for XIFAXAN

Drug Class	Rifamycin Antibacterial

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 forty US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XIFAXAN is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

Methods of treating hepatic encephalopathy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 the medicinal preparations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE IN ADULTS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULT FEMALE SUBJECTS AND SYMPTOMS THEREOF

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULT FEMALE SUBJECTS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BLOATING ASSOCIATED WITH DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS-D) IN ADULT FEMALE SUBJECTS

Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

Methods of treating travelers diarrhea and hepatic encephalopathy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING TRAVELERS' DIARRHEA

Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods for treating diarrhea-associated irritable bowel syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods of treating hepatic encephalopathy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: THE TREATMENT OF PATIENTS WITH TRAVELERS' DIARRHEA (TD) OR THE REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

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

Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

Methods of treating hepatic encephalopathy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods of treating hepatic encephalopathy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

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Glossary

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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		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 XIFAXAN

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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 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
Patent: New polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0608073
Patent: formas polimorfas de rifaximina, processos para sua produção e uso das mesmas em composições medicinais
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 94789
Patent: 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)
Estimated Expiration: ⤷ Sign Up

China

Patent: 00077
Patent: New polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0070433
Patent: NOVI POLIMORFNI OBLICI RIFAKSIMINA, POSTUPCI NJIHOVE PRIPREME I NJIHOVA MEDICINSKA UPOTREBA (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL)
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 98630
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 98630
Patent: Nouvelles formes polymorphes du rifaximin, procédés pour leur préparation et leur utilisation en tant que médicaments (New polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations)
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 96396
Patent: NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL PREPARATIONS
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 37825
Estimated Expiration: ⤷ Sign Up

Patent: 08531623
Estimated Expiration: ⤷ Sign Up

Patent: 13216710
Patent: NEW POLYMORPHISM OF RIFAXIMIN, ITS PRODUCING METHOD AND ITS USE IN PHARMACEUTICAL PREPARATIONS
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 07010742
Patent: NUEVAS FORMAS POLIMORFAS DE RIFAXIMINA, PROCEDIMIENTOS PARA SU PRODUCCION Y USO DE LA MISMA EN PREPARACIONES MEDICINALES. (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL.)
Estimated Expiration: ⤷ Sign Up

Moldova, Republic of

Patent: 81
Estimated Expiration: ⤷ Sign Up

Patent: 070265
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Montenegro

Patent: 272
Patent: NOVI POLIMORFNI OBLICI RIFAKSIMINA, POSTUPAK NJIHOVE PROIZVODNJE I NJIHOVA UPOTREBA U MEDICINSKIM PREPARATIMA (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL)
Estimated Expiration: ⤷ Sign Up

Patent: 4408
Patent: NOVI POLIMORFNI OBLICI RIFAKSIMINA, POSTUPAK NJIHOVE PROIZVODNJE I NJIHOVA UPOTREBA U MEDICINSKIM PREPARATIMA (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL)
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 345
Patent: NOUVELLES FORMES POLYMORPHES DE RIFAXIMINE, LEURS PROCEDES DE PREPARATION ET LEUR UTILISATION EN MEDECINE.
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 6737
Patent: New polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Estimated Expiration: ⤷ Sign Up

Norway

Patent: 2197
Estimated Expiration: ⤷ Sign Up

Patent: 074988
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 98630
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 98630
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 97985
Patent: НОВЫЕ ПОЛИМОРФНЫЕ ФОРМЫ РИФАКСИМИНА, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В ЛЕКАРСТВЕННЫХ ПРЕПАРАТАХ (NOVEL POLYMORPHOUS FORMS OF RIFAXIMIN, SYNTHESIS METHODS AND USE THEREOF IN MEDICINAL PREPARATIONS)
Estimated Expiration: ⤷ Sign Up

Patent: 07136430
Patent: НОВЫЕ ПОЛИМОРФНЫЕ ФОРМЫ РИФАКСИМИНА, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В ЛЕКАРСТВЕННЫХ ПРЕПАРАТАХ
Estimated Expiration: ⤷ Sign Up

Serbia

Patent: 570
Patent: NOVI POLIMORFNI OBLICI RIFAKSIMINA, POSTUPAK NJIHOVE PROIZVODNJE I NJIHOVA UPOTREBA U MEDICINSKIM PREPARATIMA (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL)
Estimated Expiration: ⤷ Sign Up

Patent: 070364
Patent: NOVI POLIMORFNI OBLICI RIFAKSIMINA, POSTUPAK NJIHOVE PROIZVODNJE I NJIHOVA UPOTREBA U MEDICINSKIM PREPARATIMA (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL)
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 98630
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0707397
Patent: New polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 0885755
Estimated Expiration: ⤷ Sign Up

Patent: 060096242
Patent: NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN MEDICINAL PREPARATIONS
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 22895
Estimated Expiration: ⤷ Sign Up

Tunisia

Patent: 07292
Patent: NEW POLYMORPHOUS FORMS OF RIFAXIMIN,PROCESSES FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 809
Patent: НОВЫЕ ПОЛИМОРФНЫЕ ФОРМЫ РИФАКСИМИНА, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В МЕДИЦИНСКИХ ПРЕПАРАТАХ;НОВІ ПОЛІМОРФНІ ФОРМИ РИФАКСИМІНУ, СПОСІБ ЇХ ОТРИМАННЯ ТА ЇХ ЗАСТОСУВАННЯ У МЕДИЧНИХ ПРЕПАРАТАХ (NEW POLYMORPHOUS FORMS OF RIFAXIMIN, PROCESS FOR THEIR PRODUCTION AND USE THEREOF IN THE MEDICINAL)
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Spain	2522895		⤷ Sign Up
China	1613858	Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations	⤷ Sign Up
South Korea	100855084		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

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Summary for XIFAXAN

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XIFAXAN

Recent Clinical Trials for XIFAXAN

Pharmacology for XIFAXAN

Paragraph IV (Patent) Challenges for XIFAXAN

Patents protecting XIFAXAN

When does loss-of-exclusivity occur for XIFAXAN?

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XIFAXAN