Last updated: February 13, 2026
What is NDC 42192-0623?
NDC 42192-0623 identifies a specific drug product registered under the National Drug Code. According to available data, it corresponds to Amoebicidal drug Tinidazole, 2 grams per tablet. Manufactured by Tanabe Pharmaceuticals, this formulation is primarily used for treating amoebiasis and certain parasitic infections.
Market Context
Therapeutic Indications
- Amoebiasis
- Giardiasis
- Trichomoniasis
- Other protozoal infections
Market Dynamics
- The drug addresses a niche but vital market, primarily in infectious disease management.
- Existing treatment options include metronidazole, with which Tinidazole competes.
- The global anti-parasitic drug market valued at approximately $1.5 billion in 2022, with a consolidation of products addressing similar indications.
Key Market Drivers
- Rising incidences of parasitic infections, especially in endemic regions.
- Increasing antibiotic resistance prompting the adoption of alternative therapies like Tinidazole.
- Growing investment in infectious disease treatment R&D.
Major Competitors
- Metronidazole (most widely used)
- Secnidazole
- Ornidazole
Market Penetration
- Currently, Tinidazole's prescription volume remains lower than metronidazole due to wider familiarity and established prescribing habits.
- The drug’s approval is mostly for specific indications; off-label use exists but is limited by regulatory and reimbursement considerations.
Regional Markets
- High demand in Latin America, Asia, and Africa due to endemic parasitic diseases.
- Regulatory approvals in the U.S., Europe, with market access varying.
Price Analysis
Current Wholesale Acquisition Cost (WAC)
- For 2-gram tablets, typical WAC ranges between $30 and $50 per tablet, depending on supplier and purchase volume.
- Estimated per-treatment course cost: approximately $60–$100, assuming a standard dosing regimen.
| Market Price Range |
Region |
Price per Tablet |
Treatment Course Cost |
| U.S. |
$35–$45 |
$70–$90 |
| Europe |
€25–€40 |
€50–€80 |
| Latin America |
$20–$35 |
$40–$70 |
Pricing Dynamics
- No direct patent restrictions exist; thus, generic versions influence price levels heavily.
- Market entry of generics has driven prices down over the past 5 years.
- Manufacturer pricing strategies focus on maintaining margins in niche indications and markets.
Price Projection and Future Trends
Assumptions
- Continued presence of generic competition.
- Stable demand in regions with endemic parasitic infections.
- Possible price erosion of 5-10% annually owing to generic proliferation.
| Projected Price Trends (Next 3-5 Years) |
Year |
Expected Price Range (per tablet) |
Major Factors Influencing Price |
| 2023 |
$30–$45 |
Market stability, generic competition |
| 2024 |
$28–$43 |
Entry of additional generics, price competition |
| 2025 |
$26–$40 |
Increased supply, potential new indications |
Potential Impact of New Approvals or Indications
- Regulatory approval for additional indications or expanded formulations could stabilize or increase pricing.
- New formulations (e.g., extended-release) could command premium pricing, contingent on demonstrated clinical advantages.
Risks and Opportunities
Risks
- Market saturation by generics, leading to low pricing.
- Limited brand differentiation options.
- Regulatory challenges in expanding indications.
Opportunities
- Expanding access in regions with high parasitic disease burden.
- Developing combination therapies to increase value.
- Leveraging unmet needs to secure premium pricing in select markets.
Key Takeaways
- NDC 42192-0623 corresponds to Tinidazole, a niche anti-parasitic drug.
- Market size remains stable but is constrained by widespread generic competition.
- Current wholesale prices range around $30–$50 per tablet with a potential for gradual decline.
- Future prices are likely to trend downward over the next five years, influenced by market saturation.
- Expansion into new indications or formulations may offer upward pricing opportunities.
FAQs
Q1: How does Tinidazole compare to metronidazole in terms of pricing and efficacy?
A: Tinidazole typically costs more per dose but has advantages like fewer adverse effects and shorter treatment courses. Price comparison varies by region, with metronidazole being substantially cheaper due to its patent expiry and production volume.
Q2: What factors influence the pricing of generic Tinidazole?
A: Production costs, regulatory compliance, market demand, and competitive pressure from other generics primarily influence generic pricing.
Q3: Are there upcoming regulatory approvals that could impact the market?
A: Currently, no major approvals are anticipated; however, expanded indications or new formulations could alter market dynamics.
Q4: How does regional demand affect pricing strategies?
A: High-demand regions like Latin America and parts of Asia tend to have lower prices due to local market competition and pricing regulations.
Q5: What are the key barriers to market entry for new competitors?
A: Regulatory approval processes, manufacturing costs, and establishing distribution channels pose significant barriers.
Citations
[1] MarketWatch, "Anti-parasitic Drugs Market Size, Trends & Forecasts," 2022.
[2] IQVIA, "Global Prescription Drug Price Trends," 2022.
[3] FDA FOI Reports, "Tinidazole Approval Documents," 2001.
[4] EvaluatePharma, "Generic Drug Market Analysis," 2022.
