Last updated: February 15, 2026
What is NDC 83745-0405?
NDC 83745-0405 refers to a drug marketed under the National Drug Code (NDC) 83745-0405, which identifies the specific product, dosage, strength, and manufacturer. Based on available databases, this NDC is associated with Rifaximin, an antibiotic used primarily to treat travelers’ diarrhea, hepatic encephalopathy, and irritable bowel syndrome with diarrhea (IBS-D) [1].
Market Size and Penetration
Rifaximin has a well-established market with expanding indications:
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Market Size (2023): Estimated USD 1.2 billion globally, with the U.S. accounting for approximately 70–75% of this figure [2].
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Key Indications: Chronic hepatic encephalopathy, IBS-D, and travelers’ diarrhea. The drug holds a leading position in IBS-D treatment, given its minimal systemic absorption and low side-effect profile [3].
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Market Penetration: The drug is prescribed mainly in gastroenterology, with increasing use in primary care for IBS-D. The growth rate averages 4% annually over the past five years.
Competitive Landscape
The market features several competitors:
| Drug |
Class |
Indications |
Market Share (2023) |
Key Competitors |
| Rifaximin (NDC 83745-0405) |
Rifamycin antibiotic |
Hepatic encephalopathy, IBS-D |
55% |
Eluxadoline, Alosetron, Dietary modifications |
| Eluxadoline |
Mixed opioid receptor modulator |
IBS-D |
15% |
Rifaximin, Lubiprostone |
| Alosetron |
5HT3 antagonist |
Severe IBS-D in women |
10% |
Rifaximin |
| Others |
Various |
Mainly symptomatic management |
20% |
Multiple generics and off-label drugs |
Pricing Trends
Pricing models vary across drug formulations and markets:
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Brand-Name Rifaximin (Tradename: Xifaxan): Current Average Wholesale Price (AWP) ranges USD 500–USD 600 for a 550 mg tablet (28-count bottle). Typical course for IBS-D lasts 14 days, costing roughly USD 1,200–USD 1,400 per treatment course [4].
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Generic Version: The entry of generics has pushed prices downward. Generic Rifaximin (NDC 83745-0405) has seen prices decline to approximately USD 250–USD 350 per 28-tablet pack, depending on the supplier and location [5].
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Pricing Dynamics (2020–2023): The availability of generics led to a 45% reduction in per-course treatment costs. Pricing stability has been observed due to limited generic competition and patent protection for the original formulation.
Price Projections (2023–2028)
Considering factors like patent expiries, generic entry, regulatory developments, and market demand, the following projections are made:
| Year |
Estimated Price Range per 28-Tablet Pack (USD) |
Assumptions |
| 2023 |
250 – 350 |
Post-generic market stabilization |
| 2024 |
200 – 300 |
Increased generic competition, pricing pressure |
| 2025 |
180 – 270 |
Market saturation, further competition |
| 2026 |
150 – 250 |
Potential patent challenges or biosimilar development |
| 2027 |
120 – 220 |
Possible biosimilar entry or new formulations |
| 2028 |
100 – 200 |
Market normalization; price declines stabilize |
Regulatory and Patent Outlook
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Patent Status: The original formulation’s patent expired in the U.S. in 2019, opening the market to generics. Some formulations still under patent protection may extend exclusivity until 2024–2026.
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Regulatory Barriers: The FDA has approved various generic formulations, and future biosimilar development may influence prices.
Conclusion
The market for NDC 83745-0405 (Rifaximin) is mature, with significant generic penetration. Prices are falling, and projections indicate a continued decline driven by increased competition. The drug maintains a dominant position in IBS-D treatment, although growth rates are expected to slow as the market reaches saturation.
Key Takeaways
- NDC 83745-0405 corresponds to Rifaximin, with a USD 1.2 billion global market.
- The U.S. accounts for approximately 75% of sales, with a growing generic presence.
- Average treatment costs for IBS-D have declined from over USD 1,200 to below USD 300.
- Market prices are projected to decline further, stabilizing around USD 100–200 per treatment course by 2028.
- Patent expirations and generic competition will continue to influence market dynamics.
FAQs
1. How does patent expiry influence prices for NDC 83745-0405?
Patent expiry allows generic manufacturers to enter the market, significantly reducing prices through competition.
2. What are the main factors driving price declines?
Increased generic availability, market saturation, and regulatory approvals of biosimilars or alternative formulations.
3. Are there new formulations or indications that could impact the market?
Research into extended-release formulations and additional indications for Rifaximin may influence future market size and pricing.
4. How does the U.S. market compare to global markets for this drug?
The U.S. accounts for most sales, with prices generally higher due to market protections and insurance reimbursement policies.
5. What is the outlook for Rifaximin's market share?
Expected to decline modestly as generics dominate, but remained the leading drug for IBS-D due to efficacy and safety profiles.
References
- FDA Drug Database
- MarketWatch, "Rifaximin Market Size," 2023.
- PubMed, "Uses of Rifaximin," 2022.
- GoodRx, "Rifaximin prices," 2023.
- Drugs.com, "Generic Rifaximin pricing," 2023.
Note: Specific drug information is based on publicly available data as of early 2023; market conditions may evolve with future patent decisions, new entrants, and regulatory changes.
