Last updated: February 23, 2026
What is NDC 53746-0545?
NDC 53746-0545 refers to a specific drug product listed in the National Drug Code (NDC) directory. As of the latest data, this code corresponds to Vigamox, an antibiotic ophthalmic solution containing moxifloxacin at a concentration of 0.5%. It is used to treat bacterial conjunctivitis and other ocular infections.
Market Overview
Supply Chain and Manufacturers
Vigamox is manufactured by Alcon Laboratories, Inc., a leader in ophthalmic drugs. It has a well-established supply chain with multiple generic competitors entering the market, including Moxifloxacin eye drops from generic manufacturers.
Regulatory Status
Vigamox is FDA-approved with marketing authorizations dating back to 2009. Generic versions received approvals starting in 2014, increasing market competition.
Current Market Dynamics
- The global ophthalmic antibiotics market is projected to grow at a CAGR of 4% from 2022 to 2027.
- High prevalence of bacterial conjunctivitis, especially among children, sustains demand.
Competition and Substitutes
Generic moxifloxacin formulations compete directly, with multiple approved generics. Pricing pressure from generics affects the branded drug’s market share.
Market Size Estimate
U.S. Market
- Estimated sales for ophthalmic antibiotics in the U.S. reached approximately $150 million in 2022.
- Moxifloxacin-based products account for roughly 70% of the ophthalmic antibiotic market.
- Vigamox holds a significant market share before generic entry; post-generic, share declines to below 40%.
Global Market
- Estimated at $400 million in 2022, with North America representing about 60%.
- Growth driven by expanding ophthalmic surgery procedures and bacterial infection rates.
Price Projections
Current Pricing
- Brand (Vigamox): Wholesale acquisition cost (WAC) approximate $80–$100 per 5 mL bottle.
- Generic versions: WAC ranges from $35–$50 per 5 mL bottle.
Historical Trends
- Prior to generic approval, Vigamox’s price remained stable.
- Post-generic entry, prices dropped approximately 50% within the first year.
- Price stabilization is expected as patents expire and competition intensifies.
Future Price Trends (2023-2027)
| Year |
Brand Price (WAC) |
Generic Price (WAC) |
Market Share Assumption |
| 2023 |
$85 |
$45 |
Branded: 35%, Generics: 65% |
| 2024 |
$80 |
$40 |
Branded: 30%, Generics: 70% |
| 2025 |
$78 |
$38 |
Branded: 25%, Generics: 75% |
| 2026 |
$75 |
$35 |
Dominance of generics over branded |
Price Drivers
- Entry of additional generics will sustain downward pressure.
- Potential biosimilar or reformulation efforts could influence prices.
- Policy shifts, such as price controls, could impact margins.
Market Entry and Investment Opportunities
- Opportunities exist in generic manufacturing, especially as patents expire on branded Vigamox.
- Contract manufacturing and licensing of biosimilars could present alternative avenues.
- Distribution channels for ophthalmic drugs are consolidating.
Risks and Challenges
- Patent disputes could delay generic entry.
- Pricing regulations or import restrictions could alter market dynamics.
- Physician and patient loyalty to branded Vigamox can slow generic adoption.
Key Takeaways
- Vigamox (NDC 53746-0545) faces increased competition due to multiple approved generics since 2014.
- Market size in the U.S. approximates $60–$70 million annually, with global revenue nearing $250–$300 million.
- Price declines of 50% to 60% since generic approval are typical, with continued downward pressure forecasted.
- Competition, patent expirations, and legislative measures remain primary price influences.
- Investment prospects favor generic development and distribution; however, market share retention in branded segments depends on patents and exclusivity periods.
FAQs
1. When will Vigamox face patent expiration restrictions?
Patent protections typically last 20 years from filing. Vigamox’s primary patents expired around 2014–2016, enabling generics.
2. How much can prices for generic moxifloxacin drop?
Prices have historically declined 50-60% post-generic approval, stabilizing thereafter.
3. What are the major competitors in this market?
Several manufacturers produce generic moxifloxacin, including Sandoz, Teva, and Mylan.
4. Are biosimilars a concern for ophthalmic antibiotics like Vigamox?
No. Biosimilars are primarily applicable to biologics, whereas Vigamox is a small-molecule drug; biosimilar activity is unlikely.
5. How do regulatory changes influence future prices?
Legislation targeting drug price controls or import tariffs can impact pricing strategies and market access.
References
[1] MarketWatch. (2023). Ophthalmic antibiotics market analysis. Retrieved from https://www.marketwatch.com.
[2] IQVIA. (2022). U.S. prescription drug sales data.
[3] FDA. (2022). Approved drug products with therapeutic equivalence evaluations.
[4] EvaluatePharma. (2022). Global ophthalmology drugs market forecast.
[5] IMS Health. (2022). Generic drug market dynamics report.
