Last updated: March 4, 2026
What is the Drug Associated with NDC 70515-0109?
NDC 70515-0109 corresponds to Amoils (povidone-iodine solution), primarily used as an antiseptic for skin, mucous membranes, and minor wound care. The product is distributed mainly through OTC channels and some prescription formulations. Its generic status influences pricing and market dynamics.
Market Landscape
Market Size and Sales Data
- The global antiseptic market was valued at approximately USD 5.8 billion in 2021.
- The U.S. market for antiseptics, including povidone-iodine products, was estimated at USD 1.2 billion in 2022.
- Demand for povidone-iodine products remains stable; growth driven by infection control protocols and wound care.
Competitive Landscape
- Major competitors: Betadine (Purdue Pharma), Avinol (generic povidone-iodine), and other store brands.
- Market share: Betadine dominates with an estimated 60-70% of retail sales.
- Price competition: Generics command 20-50% lower prices than brand-name Betadine.
Product Profile
| Attribute |
Details |
| Formulation |
Solution (vaginal, topical), ointments |
| Strength |
10% povidone-iodine solution |
| Packaging |
16 oz bottles, multidose bottles, single-dose vials |
| Route |
Topical, mucous membrane application |
Pricing Trends
- Average retail price (ARP): USD 5.00–USD 8.00 per 16 oz bottle.
- Wholesale acquisition cost (WAC): USD 2.50–USD 4.00 per bottle.
- Generic versions: 20-50% lower WAC and ARP compared to branded Betadine.
| Product |
ARP (Estimate) |
WAC (Estimate) |
Market Share |
| Betadine |
USD 7.50 |
USD 4.00 |
60-70% |
| Generic povidone-iodine |
USD 4.00 |
USD 2.50 |
20-30% |
| Store brands |
USD 5.00 |
USD 3.00 |
10-15% |
Regulatory and Patent Considerations
- No active patent for povidone-iodine formulations, making generics the primary competitors.
- Market entry barriers are low for new entrants, limited to manufacturing and distribution costs.
- OTC status reduces regulatory hurdles for retail sales but constrains pricing flexibility.
Price Projections (Next 5 Years)
Factors Influencing Prices
- Raw material costs (iodine, povidone): Variability due to supply chain disruptions.
- Competition: Increased generic penetration pressures.
- Regulatory environment: No patent protection extension expected.
- Market demand: Remains steady, with growth tied to infection control practices.
Projected Price Range (USD)
| Year |
WAC Range |
ARP Range |
Notes |
| 2023 |
USD 2.50–USD 4.00 |
USD 5.00–USD 8.00 |
Stable with current competition |
| 2024 |
USD 2.50–USD 4.00 |
USD 5.00–USD 8.00 |
Slight downward pressure from new entrants |
| 2025 |
USD 2.40–USD 3.80 |
USD 4.80–USD 7.80 |
Increased generic market share |
| 2026 |
USD 2.40–USD 3.80 |
USD 4.80–USD 7.80 |
Price stabilization expected |
| 2027 |
USD 2.40–USD 3.75 |
USD 4.75–USD 7.75 |
Market saturation potential |
Key Threats and Opportunities
- Threats: Raw material cost volatility, generic market saturation, potential regulatory changes.
- Opportunities: New formulations (e.g., combined antiseptics), private label expansion, regional market growth.
Key Takeaways
- The drug associated with NDC 70515-0109 is a povidone-iodine antiseptic with a well-established market.
- Price dynamics are driven by generic competition, raw material costs, and infection control trends.
- WAC prices are forecasted to remain stable around USD 2.50–USD 4.00 per bottle, with retail prices maintaining USD 5.00–USD 8.00.
- Market share remains concentrated in the Betadine brand, though generics are gaining adoption.
- Entry barriers are low, with pricing pressures likely to sustain over the next five years.
FAQs
1. What are the main factors affecting povidone-iodine prices?
Raw material costs, generic competition, and infection prevention trends influence prices significantly.
2. Is there patent protection for NDC 70515-0109?
No; the active formulation is off patent, allowing broad generic competition.
3. How does the market for povidone-iodine compare globally?
While the U.S. dominates, growth in Asia-Pacific and Europe occurs due to rising infection control protocols.
4. What are the primary distribution channels?
OTC retail stores, hospitals, pharmacies, and online platforms.
5. Are new formulations influencing the market?
Yes; products combining povidone-iodine with other antiseptics or in different delivery systems create incremental opportunities.
References
- Grand View Research. (2022). Antiseptic Market Size, Share & Trends Analysis.
- IQVIA. (2022). U.S. Over-the-Counter (OTC) Market Insights.
- U.S. Food & Drug Administration. (2022). OTC Monograph for Antiseptic Drug Products.
- MarketWatch. (2023). Povidone-Iodine Market Price Analysis.
- Statista. (2022). Global Antiseptic Market Data.
