Last updated: February 21, 2026
What is the drug identified by NDC 60219-1721?
NDC 60219-1721 corresponds to Trecali (Rifaximin) 550 mg, a prescription antibiotic primarily used to treat irritable bowel syndrome with diarrhea (IBS-D), hepatic encephalopathy, and other gastrointestinal infections. Rifaximin is a rifamycin-based, minimally absorbed antibiotic that targets intestinal bacteria.
Market Overview
Market Size and Growth
The global rifaximin market was valued at approximately USD 391 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8% through 2028. The increase is driven by rising prevalence of gastrointestinal disorders, expanded approved uses, and growing awareness among healthcare providers.
Key Market Players
Major competitors include:
- Alfa Wassermann (innovator of rifaximin)
- Salix Pharmaceuticals (now part of GSK)
- Norgine
- Aimmune Therapeutics (for specific indications)
Indications and Market Drivers
- IBS-D: Rifaximin's approved use since 2015 has contributed significantly to its sales. The global IBS market is worth an estimated USD 1.3 billion.
- Hepatic Encephalopathy: Approved since 2010 for secondary prevention. This indication's market is expected to grow as awareness increases.
- Traveler’s Diarrhea and Gastrointestinal Infections: Use remains niche but important.
Regulatory Trends
- The FDA approved the expanded label for IBS-D in 2015.
- European Medicines Agency (EMA) approval followed in 2016.
- Patent exclusivity expired in the U.S. in 2020, increasing generic competition.
Price Trends and Projections
Current Wholesale and List Prices
- Brand Name (Xifaxan): Approximate price for a 14-capsule pack (550 mg, 14-day course) is USD 1,000–1,200.
- Generic versions: Prices range from USD 600–750, depending on manufacturer and pharmacy.
Factors Influencing Price
- Patent expiration has driven generics, reducing prices.
- Manufacturing costs for rifaximin are relatively stable but can vary with supply chain disruptions.
- Insurance coverage and payer negotiations influence patient out-of-pocket costs.
Short-Term Price Trends
Between 2020 and 2023, retail prices for Xifaxan decreased 20–25% due to generic competition. Wholesale acquisition costs (WAC) for brand and generic versions have stabilized at USD 650–750.
Long-Term Price Projections
Over the next 3–5 years, prices are expected to decline further. Factors include:
- Increasing market penetration of generics, likely reducing retail prices by an additional 10–15%.
- Managed care organizations negotiating better discounts, further lowering costs for payers.
Impact of Competition
New formulations or alternative therapies could dampen rifaximin’s market share. However, no significant competitors with equivalent efficacy are currently online.
Key Market Constraints
- Generic price competition limits revenue potential for new entrants.
- Prescriber familiarity and non-formulary restrictions navigate the market.
- Patent challenges could push down prices faster.
Investment and Commercial Strategy Implications
- Rifaximin's market is mature with stable demand in current indications.
- Price erosions will continue, pressuring margins, especially for generic manufacturers.
- Innovation in formulations or new indications could support premium pricing in the future.
Summary of Price Forecasts (Next 3–5 Years)
| Scenario |
Wholesale Price Range (USD) |
Implication |
| Conservative (no new competitors) |
USD 600–700 |
Slight decrease driven by existing generic competition. |
| Moderate (new formulations) |
USD 700–750 |
Potential premium priced formulations could stabilize prices. |
| Aggressive (market entry of generics) |
USD 500–600 |
Significant price erosion expected. |
Final Notes
The market is characterized by high generic penetration. Price sensitivity remains high among payers and providers. Continued decline in prices is projected unless new evidence or therapies support premium positioning.
Key Takeaways
- Rifaximin (NDC 60219-1721) aligns with a mature, growing gastrointestinal drug market.
- The drug’s primary use, IBS-D, drove peak revenues pre-2020.
- Patent expiry has led to generics dominating, decreasing prices.
- Short-term prices for rifaximin are expected to decrease further, with wholesale prices dropping below USD 600.
- Future growth potential may depend on new indications or formulations.
FAQs
1. How does patent expiration impact rifaximin pricing?
Patent expiration increases generic entries, reducing prices and market exclusivity, with wholesale prices falling and lower retail margins.
2. Are there significant upcoming competitors for rifaximin?
No immediate competitors with similar efficacy are in late-stage development or approved, limiting threats in the near term.
3. What are key factors influencing rifaximin's market growth?
Growing prevalence of gastrointestinal disorders, expanded FDA labeling, and increasing generic availability influence growth and price decline.
4. How do payer negotiations affect patient access?
Managed care and pharmacy benefit managers negotiate discounts, which often lower patient copays and influence demand.
5. Could new formulations or indications change the price trajectory?
Yes. Extended-release formulations or additional indications could preserve premium pricing if approved and adopted.
References
[1] MarketWatch. (2022). Rifaximin Market Size and Growth.
[2] Grand View Research. (2023). Global Rifaximin Market Analysis.
[3] U.S. Food & Drug Administration. (2015). Xifaxan (Rifaximin) Labeling.
[4] IQVIA. (2022). Prescription Market Data.
[5] European Medicines Agency. (2016). Rifaximin Approval Details.
