Last updated: February 27, 2026
What is the Drug NDC 67457-0622?
The National Drug Code (NDC) 67457-0622 corresponds to Moxifloxacin Ophthalmic Solution, 0.5%, marketed under the brand name Vigamox. It is an antibiotic used to treat bacterial conjunctivitis and other ocular infections.
Market Size and Demand Drivers
Current Market Overview
- Prescription Volume: In the United States, approximately 1.2 million prescriptions of ophthalmic antibiotics were dispensed in 2022, with moxifloxacin accounting for roughly 25% of ophthalmic antibiotic prescriptions.
- Population Demographics: Rising incidences of bacterial eye infections, particularly among aging populations and contact lens users, elevate demand.
- Competitive Landscape: The ophthalmic antibiotic market is dominated by moxifloxacin, ciprofloxacin, and besifloxacin. Vigamox holds a significant market share, estimated at 40% of the moxifloxacin segment.
Geographic and Market Expansion
- Global Reach: Moxifloxacin ophthalmic solutions are marketed in over 50 countries. Expansion in emerging markets (e.g., Latin America, Southeast Asia) may increase overall demand.
- Medicaid and Insurance Coverage: Broad insurance coverage in the U.S. supports sustained prescription volumes.
Regulatory Environment
- FDA Approvals: The product received initial approval in 2003. New formulations and indications received approvals through 2010-2022.
- Patent Status: The original patent expired in 2012. However, exclusivity has been maintained via pediatric and orphan drug designations, as well as formulation patents expiring between 2022-2025.
Competitive Pricing Analysis
| Brand/Product |
Price per unit (average wholesale) |
Market Share (Estimated) |
Key Competitors |
| Vigamox (NDC 67457-0622) |
$35 per 0.3 mL dropper |
40% (ophthalmic moxifloxacin) |
Moxeza, Besivance, generic moxifloxacin |
| Moxeza |
$50 per 0.5 mL |
35% |
Vigamox, Besivance |
| Besivance |
$45 per 0.4 mL |
15% |
Vigamox, Moxeza |
| Generics |
$20–$30 per 0.3–0.5 mL |
10% |
Various generics |
Prices are approximate and based on wholesale acquisition cost (WAC) data.
Price Projection Outlook (2023–2028)
Factors Influencing Price Trends
- Patent and Exclusivity Expiry: Patents expiring 2022–2025 may introduce generics, driving prices down.
- Market Penetration: Increased penetration into international markets could stabilize high prices in certain regions.
- Regulatory Changes: New indications or formulation approvals could increase demand and price.
Projections
- Short-term (2023–2025): Prices for branded Vigamox are expected to decline marginally by 5–10% due to increasing generic competition.
- Mid-term (2026–2028): With the entry of multiple generics in the U.S., average wholesale prices could fall to $15–$20 per 0.3–0.5 mL unit.
- Long-term: Prices may stabilize at $10–$15 per unit in developed markets, while potentially remaining higher (up to $20) in emerging regions with less competition.
Market Entry and Competitive Strategies
- Generic Manufacturers: Focused on cost leadership, aiming to lower entry barriers and gain market share.
- Brand Companies: Will seek to extend product life cycles via line extensions, new formulations, or combination products.
- Partnerships: Collaborations with international distributors could expand market reach.
Risks and Challenges
- Pricing Pressures: Significant price erosion from generics.
- Regulatory Hurdles: Delays or denials in new indications or formulations.
- Market Saturation: Increased competition in established markets limiting growth.
Key Takeaways
- NDC 67457-0622 (Vigamox) is a leading ophthalmic antibiotic with robust existing demand.
- Market size in the U.S. is approximately 1.2 million prescriptions annually, with significant growth potential in international markets.
- The entrance of generics post-patent expiry will reduce prices, with wholesale costs expected to fall by approximately 50% by 2028.
- Pricing will be influenced by regulatory exclusivity, market penetration, and competition intensity.
- Strategic investments should consider timing with patent expirations, potential for formulations, and regulatory extensions.
FAQs
What factors are most likely to influence prices of NDC 67457-0622 in the next five years?
Patent expiration, emergence of generic competitors, and regulatory approvals for new indications or formulations drive pricing. Market demand shifts also influence prices.
How does the competition landscape affect market share?
Generics are expected to capture over 80% of the market in 3–5 years, lowering average prices. Brand Vigamox's market share will decline unless it maintains differentiation through formulations or indications.
Are there opportunities for new formulations?
Yes, preservative-free and sustained-release formulations could command premium pricing, especially for sensitive patient populations.
How significant is international market growth?
Important for revenue diversification, especially in high-growth regions such as Asia-Pacific and Latin America, where ophthalmic supplies are expanding.
What is the risk of price collapse due to generic entry?
High. Price erosion is typical post-patent expiry, with estimates suggesting a 50–60% reduction over five years.
Citations
- IMS Health. (2022). Ophthalmic Antibiotics Market Report.
- U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Patent Status.
- IQVIA. (2023). Prescription Data and Market Share Analysis.
- Pharma Intelligence. (2023). Global Ophthalmic Drugs Market Outlook.
- Clarivate. (2022). Patent and Exclusivity Data.
[1] Kotler, P., & Keller, K. (2022). Marketing Management (16th ed.). Pearson.
