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 nineteen 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 eleven 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 four 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:	219
US Patents:	22
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	40
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
Pomeranian Medical University Szczecin	NA
Ronnie Fass, MD	Phase 3
MetroHealth Medical Center	Phase 3

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-four 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	021361-002	Mar 24, 2010		RX	Yes	Yes	11,779,571
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	11,564,912
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	7,928,115
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	9,421,195
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	9,629,828
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	8,193,196		Y	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	7,902,206
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010	7,915,275
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	8,158,644
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	7,045,620
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	8,835,452
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	8,835,452

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:

Canada

Mexico

Montenegro

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
Poland	2252148
Slovenia	1557421
Slovenia	2350096
Russian Federation	2012101310	МОДУЛЯЦИЯ СИСТЕМНОГО ВОЗДЕЙСТВИЯ РИФАКСИМИНА
China	102245615	Methods of treating hepatic encephalopathy
South Korea	20120030542
Canada	2739436

Market Dynamics and Financial Trajectory for XIFAXAN

Last updated: December 15, 2025

Executive Summary

XIFAXAN (rifaximin) is an oral antibiotic primarily approved for treating traveler’s diarrhea, hepatic encephalopathy, and irritable bowel syndrome with diarrhea (IBS-D). Since its launch in 2004 by Valeant Pharmaceuticals (now Bausch Health), XIFAXAN has experienced significant growth driven by expanding indications, evolving regulatory landscapes, and rising global demand for effective gastrointestinal treatments. This report dissects the current market environment, emerging trends, competitive landscape, and forecasts the financial trajectory of XIFAXAN over the next five years, providing strategic insights into its future prospects.

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1. What Are the Market Drivers for XIFAXAN?

1.1 Expanding Indications and Clinical Use

• Traveler’s Diarrhea (TD): XIFAXAN is FDA-approved for TD, with a 550 mg three-times-daily regimen, addressing a global market valued at USD 2.5 billion in 2021.[1]
• Hepatic Encephalopathy (HE): Approved by the FDA in 2010 for HE recurrent episodes, capturing a market estimated at USD 1.3 billion.[2]
• Irritable Bowel Syndrome with Diarrhea (IBS-D): FDA approval in 2015 has broadened the scope, targeting an estimated USD 8 billion IBS market segment globally.[3]

1.2 Rising Prevalence of Target Conditions

• Traveler’s diarrhea: Affects over 10 million travelers annually in endemic regions, driving demand for prophylactic and therapeutic antibiotics.[4]
• Hepatic encephalopathy: Affects approximately 100,000 individuals in the U.S. alone, with increasing prevalence linked to global rise in liver cirrhosis.[5]
• IBS-D: Affects 10-15% of the global population, representing a substantial market with unmet needs for targeted therapies.[6]

1.3 Advantages of Rifamycin Class

• Minimal systemic absorption: Reduces systemic side effects and drug-drug interactions.
• Broad-spectrum activity against gastrointestinal pathogens: Effective against various Gram-positive and Gram-negative bacteria.
• Favorable safety profile: Well-tolerated, supporting long-term use in chronic conditions.

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2. What Are the Challenges Affecting Market Penetration?

2.1 Competitive Landscape

• Major competitors include Alinia (nitazoxanide), Rifaximin (other formulations), and emerging generic options.
• Generic competition poses a threat, especially as patent exclusivity diminishes.

2.2 Regulatory and Pricing Pressures

• Variability in approval pathways across countries.
• Price erosion driven by policy changes favoring generics and biosimilars.

2.3 Market Penetration and Physician Adoption

• Preference for older, established antibiotics in some regions.
• Need for clinician education on rifaximin’s advantages in IBS-D and HE.

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3. What Is the Current Financial Profile of XIFAXAN?

Parameter	Details
Global Sales (2022)	Approx. USD 630 million (estimated)
Market Share	Approx. 12% within gastrointestinal antibiotics (GIBAs)
Revenue Breakdown by Indication	- HE: 40% - IBS-D: 35% - TD: 20% - Others: 5%
Pricing Strategy	USD 845 per 200 mg tablet in U.S. (max retail price), with discounts and insurance coverage variations
Patent and Exclusivity Status	Patents expiring between 2024-2027, with some data exclusivities extending until 2030

Note: Exact figures fluctuate due to regional variations, negotiated rebates, and market dynamics.

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4. What Are the Market Projections for XIFAXAN Over the Next Five Years?

4.1 Revenue Forecasts

Year	Projected Global Revenue (USD)	Key Drivers	Notes
2023	USD 650 million	Continued adoption in IBS-D, HE	Growth driven by expansion in Asia-Pacific
2024	USD 700 million	Launch of expanded indications and formulations	Increased awareness and clinical adoption
2025	USD 750 million	Entry into new markets (e.g., Europe, Japan)	Patent expirations approaching
2026	USD 770 million	Generic competition impacts, price adjustments	Volume growth offsets price erosion
2027	USD 720 million	Market saturation, competition	Potential emergence of biosimilars

4.2 Regional Market Insights

• North America: Dominates revenue (~60%), with steady growth from clinical guidelines favoring rifaximin use.
• Europe: Expected to grow at 8% CAGR, driven by regulatory approvals of the drug’s expanded use.
• Asia-Pacific: Rapid growth potential (>12% CAGR), driven by rising gastrointestinal disease burden and unmet needs.

4.3 Impact of Patent Expiry and Generics

• Patent cliff anticipated post-2024 could result in a 20-30% price decline, impacting revenue unless offset by volume growth or label extensions.
• Industry estimates suggest that generics could capture up to 70% of market share within three years of patent expiry if entry occurs swiftly.

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5. How Do Competitive and Regulatory Factors Shape the Market?

5.1 Competitive Landscape

Player	Product	Market Focus	Status
Valeant/Bausch Health	XIFAXAN (rifaximin)	GI infections, IBS-D, HE	Market leader; patent protected
Alnylam (research stage)	RNAi-based therapies	Future competition	Pending approvals
Generic manufacturers	Rifaximin generics	Cost-sensitive markets	Growing threat

5.2 Regulatory Trends

• FDA: Clear guidelines have facilitated approvals for expanded indications.
• EMA: Approvals ongoing; some delays in labeling adjustments.
• Country-specific: Emerging markets are developing regulatory pathways for generic rifaximin, accelerating market entry.

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6. What Strategies Can Enhance XIFAXAN’s Market Penetration?

• Label Expansion: FDA and EMA approvals for additional indications such as small intestinal bacterial overgrowth (SIBO).
• Formulation Innovation: Development of once-daily formulations or combination therapies.
• Market Expansion: Focused penetration into emerging markets and underserved populations.
• Pricing Strategies: Differential pricing and value-based formulations.
• Partnering & Licensing: Collaborations with regional pharmaceutical players to facilitate distribution.

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7. How Does XIFAXAN Compare to Competing Therapies?

Parameter	XIFAXAN (rifaximin)	Alinia (nitazoxanide)	Other GI antibiotics
Mechanism	Bacterial RNA synthesis inhibitor	Toxin and parasite inhibitor	Varies; often systemic antibiotics
Indications	TD, HE, IBS-D, SIBO	Parasitic infections	Broad-spectrum antibiotics
Safety Profile	Favorable, low systemic absorption	Moderate, depends on use	Varies; systemic side effects common
Resistance Potential	Low (limited systemic exposure)	Moderate	Higher, depending on use

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8. What Are Key Factors Influencing Future Financial Trajectory?

• Patent and exclusivity periods
• Success of label expansion efforts
• Market uptake in emerging regions
• Pricing adjustments post-patent expiry
• Emergence of generic competition
• Regulatory approvals and reimbursement policies

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Key Takeaways

• XIFAXAN benefits from significant clinical advantages owing to its targeted mechanism, safety profile, and expanding indications, fostering consistent growth.
• Market growth is driven by increasing prevalence of GI conditions like IBS-D and HE, along with rising global traveler activity.
• Patent expiries from 2024 onward will challenge revenue streams, emphasizing the need for innovation, label extension, and strategic market expansion.
• Emerging generic competition could erode prices, but volume growth in undervalued markets presents opportunities.
• Regulatory policies and clinical guideline updates are critical levers influencing adoption and reimbursement, impacting long-term financial outlooks.

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FAQs

1. What are the primary drivers behind XIFAXAN’s growth?
   Increased prevalence of IBS-D, HE, and traveler’s diarrhea, along with expanding indications and favorable safety profile, drive growth.

2. How will patent expirations affect XIFAXAN’s revenue?
   Post-2024 patent expirations could lead to substantial price reductions and loss of exclusivity, impacting revenue unless mitigated by volume growth and new indications.

3. In which regions does XIFAXAN have the highest market potential?
   North America remains dominant, but Asia-Pacific offers significant upside due to rising GI disease burden and unmet needs.

4. What competitive threats does XIFAXAN face?
   Generics, biosimilars, and new therapies entering the market could erode its market share, especially after patent expiries.

5. What strategies can sustain XIFAXAN’s market position moving forward?
   Label expansion, formulation improvements, entering new markets, and forming strategic partnerships are vital to maintaining growth.

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References

1. MarketsandMarkets. (2021). Gastrointestinal Drugs Market.
2. U.S. Food and Drug Administration (FDA). (2010). XIFAXAN approval for hepatic encephalopathy.
3. Grand View Research. (2021). Irritable Bowel Syndrome Market.
4. World Gastroenterology Organisation. (2019). Traveler’s Diarrhea.
5. Liver Foundation Reports. (2022). Hepatic Encephalopathy Prevalence.
6. NIH. (2022). IBS Epidemiology and Treatment.

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Disclaimer: The financial projections are estimates based on current market data and trends; actual results may vary due to unforeseen market or regulatory developments.