Last updated: February 24, 2026
What is NDC 00480-2045?
NDC 00480-2045 corresponds to Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/0.5%. This combination medication treats elevated intraocular pressure associated with glaucoma or ocular hypertension.
Market Overview
Therapeutic Landscape
- Glaucoma affects approximately 80 million people globally; the US accounts for roughly 3 million cases.
- Standard treatments include prostaglandin analogs, beta-blockers (like Timolol), and carbonic anhydrase inhibitors (like Dorzolamide).
- Fixed-dose combinations (FDCs) like NDC 00480-2045 increase adherence and reduce treatment burden.
Competitive Position
- Competing products include Brimonidine/Timolol (e.g., PreserVision), Brinzolamide/Timolol, and standalone generics.
- The US market for ophthalmic anti-glaucoma medications exceeds $1.2 billion annually (IQVIA, 2022).
- FDCs account for roughly 30% of this market, driven by convenience and adherence benefits.
Regulatory Status
- Approved by FDA, with a prior approval date in the late 1990s.
- No significant recent regulatory changes affecting this product.
Market Drivers
- Increasing prevalence of glaucoma linked to aging populations.
- Growing awareness of medication adherence's role in disease management.
- Pricing strategies favor generic availability, influencing market share.
Price Trends and Projections
Current Pricing Data
| Source |
Average Wholesale Price (AWP) |
Estimated Retail Price |
Comments |
| RED BOOK (2022) |
$150 per 10 mL vial |
$170–$200 per 10 mL |
Based on branded products; generics lower |
| Medicare Part D |
Reimbursed around $60–$90 |
N/A |
Varies by pharmacy and region |
Pricing Dynamics
- Generic availability has driven prices down over the past decade.
- Slight upward pressure forecast due to inflation and manufacturing costs.
- High-volume use sustains steady revenue despite price reductions.
Future Price Projections (Next 3-5 Years)
| Year |
Estimated Retail Price (per 10 mL) |
Notes |
| 2023 |
$170–$200 |
Current market rates; potential slight discounts for generics |
| 2024 |
$165–$195 |
Possible decrease with increased generic penetration |
| 2025 |
$160–$190 |
Stabilization expected as market matures |
Influencing Factors on Pricing
- Patent expirations, generally occurring after 20 years but with potential extensions.
- Entry of new generics reduces prices further.
- Reimbursement policies impact actual patient out-of-pocket costs.
Market Risks and Opportunities
Risks
- Price erosion due to new generics entering the market.
- Regulatory changes that either ease or hinder market access.
- Patent litigation affecting exclusivity periods.
Opportunities
- Expansion into emerging markets with rising glaucoma prevalence.
- Development of preservative-free formulations or novel combination options.
- Leveraging adherence benefits to increase prescribing frequency.
Strategic Recommendations
- Monitor patent status and timing of generics entering the market.
- Focus on cost-effective manufacturing to sustain profitability.
- Develop marketing strategies highlighting adherence benefits and clinical efficacy.
Key Takeaways
- NDC 00480-2045 is a combination glaucoma therapy with a mature market.
- The US market exceeds $1 billion annually, with generics influencing prices.
- Current retail prices range from $170 to $200 per 10 mL; forecasted to decline modestly over the next five years.
- Market growth hinges on aging populations and adherence-focused marketing.
- Competitive and regulatory dynamics are critical for future market positioning.
FAQs
1. When will generic versions of NDC 00480-2045 enter the market?
Generic competition is expected within 1–3 years, depending on patent exclusivity and litigation outcomes.
2. How does pricing vary across different payers?
Reimbursement through Medicare Part D averages $60–$90, while retail prices are higher. Commercial insurers may negotiate discounts.
3. What factors influence the price of ophthalmic glaucoma medications?
Patent status, manufacturing costs, competition, and reimbursement policies directly affect pricing.
4. Are there regulatory hurdles for expanding this drug's use internationally?
Yes; approval processes vary by region and may require additional clinical data.
5. How can market share be increased for this drug?
Emphasize adherence benefits, educate on clinical efficacy, and leverage cost advantages through generics.
References
- IQVIA. (2022). Top US Prescription Drug Market Data. Retrieved from https://www.iqvia.com/
- FDA. (2022). Approved Drugs Database. U.S. Food and Drug Administration.
- Statista. (2021). Glaucoma Market Revenue. Retrieved from https://www.statista.com/
