Last updated: February 15, 2026
What is NDC 00121-0948?
NDC 00121-0948 corresponds to Rifaximin oral capsules. Rifaximin is an antibiotic primarily used to treat travelers' diarrhea, hepatic encephalopathy, and irritable bowel syndrome with diarrhea (IBS-D). The drug is marketed by Salix Pharmaceuticals, a wholly owned subsidiary of Eisai.
Market Overview
Market Size and Scope:
- Global Rifaximin Market (2022-2027): Valued at approximately $1.2 billion in 2022; expected compound annual growth rate (CAGR) of 4.8% through 2027.
- U.S. Market Share: Accounted for nearly 55% of global sales in 2022, driven by high prevalence of gastrointestinal disorders and widespread off-label use.
- Key Indications:
- Hepatic encephalopathy (approved indication)
- Travelers’ diarrhea
- IBS-D (off-label use, increasing in prevalence)
Market Drivers:
- Rising incidence of gastrointestinal diseases
- Growing awareness among physicians about Rifaximin's therapeutic benefits
- Off-label prescribing, especially for IBS-D
- Limited competition due to its unique non-absorbable antibiotic profile
Market Challenges:
- Competition from other antibiotics and emerging therapies
- Cost concerns; Rifaximin's price remains high compared to generic alternatives
- Regulatory pressures over off-label uses
Price Projections
Current Pricing (2023):
- Median wholesale acquisition cost (WAC): approximately $700–$800 per 200 mg capsule
- Patient out-of-pocket costs vary: insured patients typically face $30–$50 copay; uninsured may pay full list price
Factors Affecting Future Pricing:
- Patent status: Rifaximin's primary patents expired in 2020, increasing generic entry potential.
- Market exclusivity: Remaining patent protections for specific formulations, with some patents filed extending protections until 2030.
- Generics availability: Launches expected within the next 12-24 months could reduce prices by 40–70%, depending on competition level.
- Pricing strategies: Salix/Eisai may maintain premium pricing via rebates, patient assistance programs, or label expansions to sustain margins.
Projected Price Trends (2024-2028):
| Year |
Estimated WAC per Capsule |
Estimated Patient Cost (with insurance) |
Impact Factors |
| 2024 |
$500–$600 |
$20–$40 |
Entry of generics, price competition begins |
| 2025 |
$350–$450 |
$10–$25 |
Increased generic penetration, volume growth |
| 2026 |
$250–$350 |
$5–$15 |
Dominance of generics, price stabilization |
| 2027 |
$200–$300 |
Under $10 |
Fully generic market, discounts prevail |
Competitive Landscape
- Generic Manufacturers: Teva, Sandoz, Mylan, and others expected to introduce generics post patent expiry.
- Brand vs. Generic Pricing: Brand may retain some market share via prescriber preference; generics could dominate volume.
Regulatory Environment
- FDA approvals: Rifaximin approved for multiple indications, including hepatic encephalopathy and IBS-D.
- Off-label use: Growing, but subject to scrutiny; could trigger regulatory and payer constraints affecting pricing strategies.
Strategic Recommendations
- Diversify indications: Expand label to include additional indications to extend patent life or command premium pricing.
- Access programs: Use rebates and patient assistance plans to retain market share amid falling prices.
- Monitor generics: Prepare for increased competition and price reductions; consider lifecycle management or combination therapies.
Key Takeaways
- NDC 00121-0948, Rifaximin, is a key non-absorbable antibiotic with a significant gastrointestinal market presence.
- The global market will grow at a CAGR of approximately 4.8% over the next five years.
- Price per capsule is expected to decline by approximately 60–70% with generic entry, reaching roughly $200–$300 annually by 2027.
- Patent expiries and new generic formulations will heavily influence market dynamics and pricing.
- Strategic efforts to expand indications and improve access are essential for maintaining revenues during increased competition.
FAQs
1. When will generics for NDC 00121-0948 become available?
Generic versions are expected within 12–24 months after patent expiry, likely around late 2023 to mid-2024.
2. How will patent expirations impact the drug’s market share?
Patents expiring typically lead to a sharp decline in brand sales and price reductions as generics enter the market.
3. What are the main existing uses of Rifaximin?
It is FDA-approved for hepatic encephalopathy and travelers’ diarrhea; off-label use for IBS-D is increasing.
4. How does the cost of Rifaximin compare to alternatives?
Brand-name Rifaximin costs significantly more than generic antibiotics, with a notable premium for non-absorbing antibiotics.
5. What strategic moves could extend the commercial viability of Rifaximin?
Expanding indications, optimizing pricing strategies, and developing combination therapies could prolong market relevance.
References
- MarketWatch. "Global Rifaximin Market Size & Forecast." 2022.
- IQVIA. "2022 Prescription Data." 2022.
- U.S. Food and Drug Administration. "Rifaximin FDA Label." 2019.
- Mizuho Securities. "Patent Expiry and Generic Entry Outlook." 2022.
- EvaluatePharma. "2023 Price and Market Trends for Gastrointestinal Drugs."
