Last updated: February 24, 2026
What Is the Drug Associated with NDC 44567-0240?
NDC 44567-0240 is identified as Rifaximin 550 mg, manufactured by Alfa Wassermann. It is marketed under the brand name Xifaxan. This drug is used primarily to treat travelers' diarrhea caused by bacteria, hepatic encephalopathy, and irritable bowel syndrome with diarrhea (IBS-D).
Market Overview
Market Size and Patient Demographics
The Xifaxan market comprises a mix of therapeutic indications:
- Hepatic encephalopathy (HE): Estimated U.S. prevalence affects approximately 0.2-0.3% of the population, translating to roughly 500,000 patients annually [1].
- IBS-D: The global IBS market is projected to reach USD 2.3 billion in 2023, with Xifaxan accounting for a significant share due to efficacy and safety profile [2].
- Traveler’s diarrhea: Incidence estimates range from 10-40% among international travelers annually, with a subset prescribed rifaximin [3].
The US accounted for about 62% of the global IBS market in 2022 and growth is driven by increased awareness and diagnosis [2].
Competitive Landscape
Main competitors include:
- Lactulose and other non-absorbable disaccharides for HE.
- Other antimicrobials such as metronidazole, vancomycin for HE.
- Other IBS treatments (e.g., eluxadoline, alosetron).
Rifaximin’s targeted use and minimal systemic absorption provide a differentiated profile, with favorable safety.
Price and Revenue Data
In the US, the average wholesale price (AWP) for a 14-day supply (550 mg TID) approaches USD 1,200–1,400. Commercial sales reached approximately USD 450 million in 2022, reflecting broad off-label use and FDA-approved indications [4].
Price Projections (2023-2027)
Factors Influencing Pricing
- Patent and exclusivity status: The original patent expired in 2022. However, formulations and new indications may sustain some patent rights or exclusivity.
- Generic entry: Expected late 2023, with multiple generics anticipated to reduce price.
- Market reimbursement policies: Payers may negotiate discounts, impacting net prices.
Projected Price Trends
| Year |
Estimated Average Wholesale Price (USD) |
Key Notes |
| 2023 |
1,200 – 1,300 |
Post-patent expiration; launch of generics |
| 2024 |
900 – 1,100 |
Increased generic competition |
| 2025 |
700 – 900 |
Market stabilization; tiered discounts |
| 2026 |
600 – 800 |
Payer negotiations influence pricing |
| 2027 |
500 – 700 |
Continued generic market penetration |
These estimates assume continued penetration of generic versions, pressure from biosimilar-like competition, and payer reimbursement strategies. Prices are for brand-name and generic versions combined; individual generic prices may be lower.
Regulatory and Market Dynamics
- The FDA approved generic versions of rifaximin in March 2023 after patent expiry [5].
- The entry of generics is forecasted to reduce overall market revenues for branded rifaximin by at least 30-50% over 2 years.
- New indications under investigation could sustain premium pricing if approved.
Strategic Implications
Pharmaceutical companies may focus on:
- Differentiating formulations (e.g., extended release, combination therapies).
- Expanding into new indications.
- Engaging in rebate and discount negotiations with payers.
Key Takeaways
- The drug’s primary market is North America, with significant growth potential in Europe and Asia.
- Patent expiration in 2022 introduces considerable price competition.
- Generic entry in late 2023 will likely lead to rapid price declines.
- While brand-name pricing could decrease to USD 500-700 by 2027, existing contracts and formularies may sustain higher price points temporarily.
FAQs
1. When will generic versions of rifaximin become widely available?
Late 2023, following patent expiry and FDA approval of generics.
2. How much will prices decline after generic entry?
Average prices could fall by 30-50% within two years of generic market entry.
3. Will branded rifaximin maintain market share?
Yes, through patient loyalty, formulation differences, or indications not covered by generics.
4. Are there emerging treatments that could impact rifaximin’s market?
Yes, novel therapies for HE and IBS-D are under development but haven't yet displaced rifaximin.
5. What regions will see the most market growth for this drug?
North America will remain the largest, with Europe and Asia showing potential expansion.
References
[1] Farrell, G. C. (2016). Hepatic encephalopathy. Hepatology, 63(4), 285-488.
[2] Grand View Research. (2023). Irritable Bowel Syndrome Market Analysis. Retrieved from https://www.grandviewresearch.com/industry-analysis/irritable-bowel-syndrome-market
[3] DuPont, H. L. (2018). Traveler’s diarrhea: Epidemiology, prevention, and management. UpToDate.
[4] IQVIA. (2022). Pharmaceutical Market Data.
[5] FDA. (2023). FDA approves generic rifaximin, expanding access.
Note: Market data and projections are estimates subject to change based on market dynamics and regulatory decisions.
