XIFAXAN Drug Patent Profile

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

This drug has two hundred and eighteen patent family members in forty-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^® 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 three tentative approvals for the generic drug (rifaximin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XIFAXAN

International Patents:	218
US Patents:	22
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	39
Patent Applications:	5,026
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

See drug prices for XIFAXAN

See drug sales revenues for XIFAXAN

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

Constraining patent/regulatory exclusivity:

8,193,196

NDA:

021361

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,193,196

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 thirty-three US patents.

This potential generic entry date is based on patent 8,193,196.

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

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	021361-001	May 25, 2004		RX	Yes	Yes	8,741,904			Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	7,906,542		Y	Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	10,765,667
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	10,314,828
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	10,703,763
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	10,335,397
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	9,271,968		Y

Expired US Patents for XIFAXAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	7,915,275
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	8,835,452
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	7,902,206
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	7,045,620
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	8,158,781
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	8,853,231
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	8,158,781

International Patents for XIFAXAN

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

Country	Patent Number	Title	Estimated Expiration
China	102596250	Methods for treating irritable bowel syndrome (IBS)
European Patent Office	2437603
European Patent Office	3964066	PROCÉDÉS DE TRAITEMENT DE L'ENCÉPHALOPATHIE HÉPATIQUE (METHODS OF TREATING HEPATIC ENCEPHALOPATHY)
Japan	2011057698	POLYMORPHOUS FORM OF RIFAXIMIN, PRODUCTION METHOD THEREFOR AND USE THEREOF IN MEDICAL PREPARATION
Mexico	2007010742	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.)
Russian Federation	2004108953
Spain	2972135

Market Dynamics and Financial Trajectory for XIFAXAN (Rifaximin)

Overview of XIFAXAN (Rifaximin)

XIFAXAN, also known as rifaximin, is a broad-spectrum antibiotic that has gained significant traction in the pharmaceutical market due to its efficacy in treating various gastrointestinal disorders. Developed by Alfa Wassermann and marketed by Salix Pharmaceuticals in the US, XIFAXAN is approved for treating conditions such as hepatic encephalopathy, irritable bowel syndrome (IBS), and traveler's diarrhea[3].

Market Size and Growth Projections

The market for rifaximin is experiencing robust growth. As of 2023, the global rifaximin market was valued at USD 121 billion and is projected to reach USD 200.25 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.5% from 2024 to 2031[1].

Another report indicates a slightly different valuation, with the market size valued at USD 1.27 billion in 2023 and expected to reach USD 4.11 billion by 2031, growing at a CAGR of 11.7% during the forecast period[4].

Key Drivers of Market Growth

Increasing Prevalence of Gastrointestinal Disorders

The rising incidence of gastrointestinal disorders such as IBS, Crohn’s disease, and traveler’s diarrhea is a significant driver of the rifaximin market. As more individuals seek effective treatments for these conditions, the demand for rifaximin has increased substantially[4].

Growing R&D Activities

Pharmaceutical companies are investing heavily in research and development to explore new uses for rifaximin beyond its current indications. Clinical trials and studies are ongoing to investigate its potential benefits in treating small intestinal bacterial overgrowth (SIBO) and inflammatory bowel disease (IBD), among other conditions. This R&D activity is expected to expand the therapeutic utility and market potential of rifaximin[1][4].

Rising Awareness and Acceptance

The growing awareness and acceptance of rifaximin among healthcare providers and patients are critical factors driving market growth. Educational initiatives and patient advocacy campaigns have improved the understanding of rifaximin’s safety profile and efficacy, making it a preferred treatment option for gastrointestinal diseases[4].

Regulatory Approvals and Expansions

Favorable regulatory approvals across various regions have fortified the market presence of rifaximin. Streamlined regulatory processes and global pharmaceutical partnerships have facilitated the drug’s availability in emerging markets, contributing to its growing sales[1][4].

Financial Performance

Revenue Trends

Bausch Health Companies Inc., the parent company of Salix Pharmaceuticals, reported significant revenue growth driven by the sales of XIFAXAN. In the full year of 2021, the Salix segment revenues were $2.074 billion, an increase of 9% compared to the previous year, primarily driven by higher sales of XIFAXAN, among other products[2].

In the second quarter of 2024, Salix revenues totaled $558 million, with XIFAXAN revenues up by 10%, contributing to the strong growth in the underlying segment[5].

Segment Performance

The financial performance of XIFAXAN is closely tied to the overall performance of the Salix segment within Bausch Health. The segment has shown consistent growth, driven by the positive impacts of the recovery from the COVID-19 pandemic and increased sales of key products like XIFAXAN[2].

Competitive Landscape

Market Competition

The rifaximin market faces intense competition from generic versions of the drug and other antibiotics. This competition drives prices down and impacts profit margins for original brand manufacturers. The proliferation of alternative treatments for gastrointestinal disorders further intensifies the competitive pressure, necessitating strategic marketing and innovation efforts to maintain market position[4].

Porter’s Five Forces Analysis

A comprehensive analysis of the market dynamics includes a Porter’s Five Forces analysis, which examines the buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition in the global rifaximin market. This analysis highlights the competitive landscape and the various participants in the market ecosystem, including system integrators, intermediaries, and end-users[1].

Geographical Segmentation

The rifaximin market is segmented geographically into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific segment is rapidly expanding due to improving healthcare infrastructure and rising awareness of gastrointestinal diseases. Latin America and the Middle East and Africa also present growth opportunities, though they face unique challenges such as price sensitivity and varying regulatory hurdles[1][4].

Challenges and Restraints

Limited Awareness in Certain Regions

Despite its growing acceptance, rifaximin still faces challenges in regions where awareness about gastrointestinal diseases and the benefits of rifaximin is limited. Price sensitivity and affordability issues in emerging markets are additional restraints that need to be addressed through targeted marketing and educational initiatives[4].

Competitive Pressure

The presence of generic versions and other therapeutic agents poses a significant challenge to the market growth of rifaximin. Companies must invest in innovation and differentiation to maintain their market share and mitigate the effects of price erosion and market saturation[4].

Future Outlook

The future outlook for the rifaximin market is promising, driven by the increasing prevalence of gastrointestinal disorders, ongoing R&D activities, and growing awareness and acceptance among healthcare providers and patients. Favorable regulatory approvals and expansions into new geographical markets are expected to further boost the market growth.

New Indications and Formulations

Ongoing clinical trials and studies are likely to uncover new indications for rifaximin, such as SIBO and IBD, which will expand its therapeutic utility and market potential. New formulations and combinations may also emerge, enhancing the drug’s efficacy and opening up new market segments[1][4].

Market Expansion Strategies

To maintain and grow market share, companies will need to focus on strategic marketing, innovation, and differentiation. This includes educational initiatives, patient advocacy campaigns, and partnerships to increase the drug’s availability in emerging markets.

Key Takeaways

• The global rifaximin market is projected to grow significantly, driven by the increasing prevalence of gastrointestinal disorders and ongoing R&D activities.
• Favorable regulatory approvals and growing awareness among healthcare providers and patients are key drivers of market growth.
• The market faces intense competition from generic versions and other therapeutic agents, necessitating strategic marketing and innovation efforts.
• Geographical expansion, particularly in the Asia-Pacific, Latin America, and Middle East and Africa regions, presents significant growth opportunities.
• New indications and formulations are expected to further expand the market potential of rifaximin.

FAQs

What are the primary indications for XIFAXAN (rifaximin)?

XIFAXAN is primarily indicated for the treatment of hepatic encephalopathy, irritable bowel syndrome (IBS), and traveler's diarrhea.

What is driving the growth of the rifaximin market?

The growth of the rifaximin market is driven by the increasing prevalence of gastrointestinal disorders, ongoing R&D activities, growing awareness and acceptance among healthcare providers and patients, and favorable regulatory approvals.

Which regions are expected to see significant growth in the rifaximin market?

The Asia-Pacific, Latin America, and Middle East and Africa regions are expected to see significant growth due to improving healthcare infrastructure, rising awareness of gastrointestinal diseases, and increasing healthcare access.

How does competition affect the rifaximin market?

The presence of generic versions and other therapeutic agents poses a significant challenge to the market growth of rifaximin, driving prices down and impacting profit margins for original brand manufacturers.

What are the future outlook and potential new indications for rifaximin?

The future outlook is promising, with ongoing clinical trials and studies expected to uncover new indications such as SIBO and IBD, expanding its therapeutic utility and market potential.

Sources

1. Market Research Intellect, "Rifaximin Market Size, Trends and Projections".
2. PR Newswire, "Bausch Health Companies Inc. Announces Fourth-Quarter And Full-Year 2021 Results And Provides 2022 Guidance".
3. PR Newswire, "Xifaxan (Irritable Bowel Syndrome) - Forecast and Market Analysis to 2023".
4. Verified Market Research, "Rifaximin Market Size, Scope, Growth, Trends and Forecast".
5. Nasdaq, "Bausch Health (BHC) Q2 Earnings In Line, Xifaxan Boosts Sales".