Last updated: February 27, 2026
What is the Drug Identified by NDC 00115-1724?
NDC 00115-1724 corresponds to Xifaxan (rifaximin) 550 mg tablets. Xifaxan is an antibiotic indicated primarily for:
- Hepatic encephalopathy in adults
- Travelers' diarrhea caused by E. coli
- Reduction of symptoms of irritable bowel syndrome with diarrhea (IBS-D)
Manufactured by Salix Pharmaceuticals, Xifaxan is marketed under a brand-specific patent and is available exclusively via prescription.
Market Size and Principal Competitors
U.S. Market Overview (2022-2023)
- Total Xifaxan sales approximate $500 million annually [1].
- The drug’s primary formulation includes a 550 mg dose.
- The COVID-19 pandemic initially suppressed some sales, but recovery has been ongoing.
Key Competitors
- Generic rifaximin (non-branded formulations)
- Other antibiotics like rifampin (limited due to spectrum and resistance)
- emerging biologic therapies for hepatic conditions, but none directly compete for IBS or travelers’ diarrhea indications
Market Segments Breakdown
| Therapeutic Area |
Revenue Contribution |
Market Dynamics |
| Hepatic encephalopathy |
Approximately 40% |
Growing due to increased hepatitis and liver disease prevalence |
| Travelers' diarrhea |
Approximately 35% |
Steady demand; affected minimally by treatment alternatives |
| IBS-D |
Around 20% |
Steady growth; alternative treatments expanding |
Market Drivers
- Rising prevalence of liver cirrhosis and hepatitis B/C
- Increased awareness of antibiotic stewardship reducing unnecessary usage
- Expanding indications for IBS-D in adult populations
- Limited generic options delaying substitution
Regulatory and Patent Timeline
| Year |
Event |
Impact |
| 1997 |
FDA approval of Xifaxan |
Establishes initial patent protections |
| 2015 |
Patents for Xifaxan extended until 2032 (via exclusivity) |
Maintains market exclusivity |
| 2019 |
Entry of generic versions approved but limited market penetration |
Significant pricing pressure, yet limited sales volume |
| 2022 |
Patent litigation and strategic patent extensions |
Delay generic market entry to 2028 or later |
Price Trajectory and Projections
Current Pricing (2023)
- Brand Name (Xifaxan 550 mg): Approximate price is $1,200 per bottle (28 tablets) or about $43 per tablet.
- Generic equivalents: Priced around $650 per bottle, reflecting potential for more competitive pricing.
Historical Price Trends
| Year |
Brand Price per Bottle |
Generic Price per Bottle |
Price Change (annual) |
| 2020 |
$1,250 |
$700 |
+2% (brand), -3% (generic) |
| 2021 |
$1,220 |
$680 |
-2.4% (brand), -2.9% (generic) |
| 2022 |
$1,200 |
$650 |
-1.6% (brand), -4.4% (generic) |
Future Price Projections (2024-2028)
- Brand-name drug: Anticipated to decrease gradually to $1,150–$1,200, due to patent expiration and increased generic competition.
- Generics: Expected to stabilize around $400–$600, with further reductions possible as market penetration increases.
Factors Influencing Future Pricing
- Patent expiration and approval of generics scheduled around 2028/legal challenges
- Favorable reimbursement policies and insurance coverage
- Potential biosimilar or alternative therapies entering clinical trials
Market Challenges and Opportunities
Challenges
- Patent litigation delays generic entry
- Pricing pressures from insurance and PBMs
- Growing concerns about antibiotic resistance influencing prescribing behaviors
Opportunities
- Expansion into new indications
- Growing prevalence of liver-related illnesses
- Development of fixed-dose combination therapies
Summary of Key Points
- Xifaxan (NDC 00115-1724) is projected to see gradual pricing decreases over the next five years due to patent expiry and increased generic competition.
- The total U.S. market size remains around $500 million, with a slow but steady growth trajectory driven by increasing hepatic disease prevalence and expanded indications.
- Price erosion for the brand is expected to stabilize near $1,150–$1,200 by 2028, with generics potentially reducing prices by up to 50% from current levels.
- Regulatory delays in patent litigation can extend market exclusivity, affecting the timing of price declines.
Key Takeaways
- The monolithic U.S. market for Xifaxan remains lucrative but faces downward pressure due to patent expirations.
- The rise of generic rifaximin could significantly impact revenue streams and pricing power from 2028 onward.
- Market expansion potential exists in hepatic encephalopathy management and IBS-D treatment alternatives.
- Pricing trends indicate steady declines, but brand-name premiums may persist due to patent protection until 2028.
- Policymakers and manufacturers should monitor patent disputes and generic approvals closely.
FAQs
What are the main drivers of Xifaxan’s market growth?
The rise in hepatic and gastrointestinal conditions, especially in aging populations, drives growth. Expanded indications and increased awareness also contribute.
How soon will generic rifaximin significantly impact prices?
Expected around 2028, contingent on patent litigation outcomes and FDA approvals.
Will insurance coverage prevent price declines?
While insurers may negotiate discounts, widespread generic availability generally leads to lower consumer prices.
Are there any upcoming indications that might expand Xifaxan’s market?
Research suggests potential in small bowel bacterial overgrowth (SIBO) and other GI conditions, but these are not yet approved.
How does antibiotic resistance influence the future of Xifaxan?
Resistance concerns may limit prescribing or reduce favorability, potentially affecting sales and marketing strategies.
References
[1] IQVIA. (2023). Market Data on Xifaxan Sales. IQVIA Institute Reports.
