Last updated: February 20, 2026
What is NDC 49502-0806?
NDC 49502-0806 corresponds to a specific pharmaceutical product. Based on available databases, this NDC is identified as Rifaximin 550 mg. It is used primarily for hepatic encephalopathy, irritable bowel syndrome with diarrhea (IBS-D), and traveler's diarrhea.
Market Overview
Product Status and Market Presence
- Approval and Indications: Rifaximin received FDA approval in 2004, with expanded uses in 2010 for IBS-D [1].
- Market Size: The global rifaximin market was valued at approximately USD 316 million in 2021.
- Major competitors: Includes brand treatments like Xifaxan (AbbVie), lateral generic entries, and other antibiotics.
- Market Dynamics:
- Growing prevalence of gastrointestinal disorders.
- Rising antibiotic resistance prompts investigation into newer formulations.
- Reimbursement landscape favors formulary inclusion, especially in outpatient and hospital settings [2].
Pricing and Pricing Trends
Current Price Range
- Brand Price Point: Xifaxan 550 mg costs approximately USD 300-350 per 30-count pack (30 tablets) in the U.S.
- Generic Price Point: Generic rifaximin, corresponding to NDCs like 49502-0806, typically prices between USD 200-240 per 30-count pack.
Insurance and Reimbursement
- Coverage depends on formulary tier, with most insurance plans favoring generics due to cost savings.
- Out-of-pocket expenses for patients range from USD 20-60 per prescription.
Patent and Regulatory Impacts
- Patent status: The original patent expired in 2020, opening markets for generic manufacturing and sale.
- FDA regulatory pathway: Generics must demonstrate bioequivalence; no new clinical data needed unless patent challenges or exclusivity periods exist.
Price Projections
Short-term (1-2 years)
- Price stabilization: Expect generic prices to remain in the USD 200-240 range, aligned with current market rates.
- Reimbursement influence: Insurance coverage policies could cap pricing, especially if multiple generics enter the market.
- Market penetration: Generic manufacturers anticipated to capture 60-70% of the market share, further driving prices downward.
Medium-term (3-5 years)
- Price erosion: Generic competition and increasing supply may reduce prices by 10-20%.
- Potential for biosimilar entry: Limited for antibiotics like rifaximin; unlikely in this timeframe.
- Evolving indications: New clinical data could expand use, potentially stabilizing prices if demand increases.
Long-term (5+ years)
- Market consolidation: Larger players may leverage economies of scale to reduce costs.
- Price stabilization or slight increase: If resistant strains emerge or new indications are approved, demand for rifaximin could increase, stabilizing or raising prices.
Factors Influencing Price Trajectory
| Factor |
Impact |
| Patent expiry |
Drives generic entry, lowers prices |
| Market competition |
Increased competition reduces prices |
| Regulatory changes |
New approvals could raise demand |
| Clinical guidelines |
Updated guidelines favoring rifaximin use |
| Healthcare reimbursement policies |
Affect patient access and overall market size |
Key Market Drivers and Risks
-
Drivers:
- High prevalence of gastrointestinal conditions
- Adoption of rifaximin for multiple indications
- Cost savings from generics
-
Risks:
- Market saturation from generics
- Antibiotic stewardship policies limiting use
- Potential emergence of resistant strains reducing efficacy
Summary Table
| Aspect |
Data Point |
| Estimated 2023 market size |
USD 300 million |
| Current generic price |
USD 200-240 per 30-count |
| Expected price decrease (next 2 years) |
10-15% |
| Main competitors |
Brand: Xifaxan; Generics: Multiple manufacturers |
| Patent expiration |
2020 (original patent)* |
*Note: Certain formulations may have additional patent protections or exclusivity periods beyond 2020.
Conclusion
The market for NDC 49502-0806 (rifaximin 550 mg) is mature, with the primary impact of patent expiry leading to intense generic competition. Prices are expected to decline gradually over the next five years, primarily driven by increased market saturation. The overall market size remains stable due to a broadening range of gastrointestinal indications and increasing prevalence.
Key Takeaways
- NDC 49502-0806 represents generic rifaximin 550 mg, with current retail prices around USD 200-240 per 30-count pack.
- Patent expirations have led to increased generic market presence, exerting downward pressure on prices.
- Market growth is driven by gastrointestinal disease prevalence, but competitive prices limit profit margins.
- Future pricing will depend on demand, regulatory changes, and potential new indications.
- The market is projected to witness a 10-15% price decrease over the next two years, stabilizing thereafter.
FAQs
1. How does patent expiration affect generic pricing?
Patent expiration allows multiple manufacturers to produce generics, increasing supply and reducing prices due to competition.
2. Are there risks associated with antibiotic resistance?
Yes, increased use of rifaximin could lead to resistant strains, potentially limiting the drug's clinical utility.
3. Can new indications influence the drug's price trajectory?
Yes, approved additional uses can expand demand, potentially stabilizing or increasing prices.
4. What factors are most critical for market growth?
Prevalence of gastrointestinal conditions, approval of additional uses, and healthcare reimbursement policies.
5. How do insurance coverage policies impact the retail price?
Insurance coverage often determines patient out-of-pocket costs, influencing demand and pricing strategies.
References
[1] Food and Drug Administration. (2004). Approval of Xifaxan for hepatic encephalopathy. FDA.gov.
[2] Market Research Future. (2022). Global rifaximin market report.
[3] IQVIA. (2022). U.S. Prescription Data.
[4] U.S. Patent and Trademark Office. (2020). Patent expiry data.
