Last updated: March 13, 2026
What is the drug with NDC 00093-1122?
NDC 00093-1122 corresponds to Rifaximin Oral Tablets, 550 mg, marketed mainly under the brand name Xifaxan by Alfa Wassermann and its collaborators. It is an antibiotic used primarily for traveler's diarrhea, hepatic encephalopathy, irritable bowel syndrome with diarrhea (IBS-D), and other gastrointestinal conditions.
Market Overview
Current Market Size
The global gastrointestinal antibiotics market, including rifaximin, was valued at approximately $500 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 4.2% from 2023 to 2030 (Grand View Research, 2022).
In the United States, the rifaximin market was estimated at $190 million in 2022, mainly driven by treatment guidelines for hepatic encephalopathy and IBS-D. The volume of prescriptions has increased annually by approximately 5% over the past three years.
Major Competitors
- Xifaxan (Alfa Wassermann GmbH)
- Other antibiotics like metronidazole and ciprofloxacin used for similar indications.
- Emerging generics: Multiple companies have launched generic versions post-patent expiration.
Patent Status and Regulatory Milestones
- Original patent held by Salix Pharmaceuticals, expiring in 2024.
- Abbreviated New Drug Application (ANDA) submissions for generic rifaximin approved by the FDA since 2020.
- The expiration of Salix's patent in 2024 is expected to trigger increased generic entry.
Distribution Channels
- Hospitals: 40%
- Retail pharmacies: 35%
- Mail-order pharmacies: 25%
Prescribing Trends
- Rising prevalence of liver-related conditions, increasing overall demand.
- Approved expansion into IBS-D after FDA approval in 2015.
- Growing awareness and diagnosis rate for hepatic encephalopathy.
Price Projections
Historical Pricing Trends
- Brand-name Xifaxan (550 mg): Retail price approximately $1,100 for a 14-tablet pack (~7.86 cents per mg).
- Generic versions: Priced between $500–$700 per 14-tablet pack, reflecting a significant drop post-patent expiry.
Current Pricing Dynamics
- Brand Xifaxan (550 mg): Approximately $1,050–$1,150 per pack.
- Generic rifaximin: $450–$650 per pack, depending on supplier and pharmacy discounts.
Projected Price Trends (2023–2030)
| Year |
Brand Price (per pack) |
Generic Price Range (per pack) |
Key Factors |
| 2023 |
$1,050–$1,150 |
$450–$650 |
Patent expiry approaches, increasing generic entry |
| 2024 |
$950–$1,050 |
$250–$400 |
Major patent losses, proliferation of generics |
| 2025 |
$800–$950 |
$200–$350 |
Increased competition, pricing pressure |
| 2026–2030 |
$700–$900 |
$150–$300 |
Market saturation, further generics approval |
Factors Affecting Prices
- Patent expiration: 2024 signifies a core price decline.
- Generic market entry: Expected to stabilize prices at a lower range.
- Drug utilization: Rising rates in hepatic encephalopathy and IBS-D sustain demand.
- Reimbursement policies: Changes could influence retail and pharmacy pricing strategies.
Regulatory and Market Forces
- The US FDA approvals of multiple generic versions have increased price competition.
- Potential for biosimilar or new formulation approvals remains low, given current indications.
- Price negotiations through pharmacy benefit managers (PBMs) could further lower consumer costs.
Geographic Variations
- North America: Prices remain highest due to demand and healthcare infrastructure.
- Europe: Slightly lower prices owing to price controls.
- Emerging markets: Prices for generics are significantly lower, around $50–$150 per pack.
Key Market Drivers and Challenges
| Drivers |
Challenges |
| Rising prevalence of hepatic encephalopathy and IBS-D |
Patent law complexities and regulatory delays |
| Approval of generics reduces prices |
Limited formulations for specific indications |
| Increased awareness of gastrointestinal disorders |
Potential for commoditization decreasing margins |
Conclusions
- The impending patent expiration in 2024 will significantly decrease brand prices.
- The generic rifaximin market will dominate post-2024, stabilizing prices at a lower threshold.
- Market growth will largely depend on the prevalence of hepatic encephalopathy and IBS-D, along with healthcare access expansion.
Key Takeaways
- Rifaximin (NDC 00093-1122) is a key gastrointestinal antibiotic with steady demand.
- Patent expiry in 2024 will result in substantial price reductions due to generic entry.
- Market value will decline from over $1,000 per pack for the brand to potentially below $300 for generics.
- Growth prospects are tied to disease prevalence, diagnosis rates, and healthcare policies.
- Competitive pressures will likely lead to price stabilization over the next five years.
FAQs
Q1: When does the patent for the original rifaximin version expire?
A1: The patent is set to expire in 2024, opening the market to generics.
Q2: How much could generic rifaximin cost post-2024?
A2: Expected to range between $150 and $300 per pack, down from over $1,000 for the brand.
Q3: Which factors influence rifaximin's pricing?
A3: Patent status, generic market entry, demand for GI treatments, and reimbursement policies.
Q4: Are there new formulations or indications planned for rifaximin?
A4: No notable new formulations; current approvals focus on existing GI conditions.
Q5: How will market share shift after patent expiration?
A5: Generics could capture over 80% of the market, significantly reducing brand market share and price.
References
- Grand View Research. (2022). Gastrointestinal antibiotics market size, share & trends analysis report.
- U.S. Food and Drug Administration. (2020). ANDA approvals for rifaximin.
- IQVIA. (2022). U.S. prescription drug trends report.
