Last updated: March 2, 2026
What Is the Drug Associated with NDC 43598-0625?
NDC 43598-0625 refers to Dorzolamide Hydrochloride Ophthalmic Solution, 2%. It is a generic medication used to lower intraocular pressure in conditions such as glaucoma and ocular hypertension. This drug is marketed primarily for ophthalmic indications and is similar to the branded product Trusopt.
Market Size and Key Drivers
Global and US Market Estimates
The global ophthalmic drug market was valued at approximately $15 billion in 2022, with the US accounting for about 40% ($6 billion). The specific niche for glaucoma medications, including dorzolamide, is estimated at $2 billion annually within the US.
Key Drivers
- Prevalence of glaucoma: 3 million Americans affected in 2022, projected to rise to 4 million by 2030 (American Academy of Ophthalmology).
- Growing aging population: Aging increases glaucoma risk, expanding market potential.
- Generic competition: Several generics, including NDC 43598-0625, have entered the market, influencing prices.
Market Participants
- Brand-name: Trusopt by Novartis
- Generics: Multiple, including NDC 43598-0625
- Distribution channels: Wholesale, hospital pharmacies, retail pharmacies, mail order.
Pricing Trends and Competition
Historical Pricing Data
| Year |
Avg. Wholesale Acquisition Cost (WAC) per unit |
Notes |
| 2018 |
$55 |
Brand-name Trusopt |
| 2020 |
$15 |
Entry of generics; NDC 43598-0625 introduced |
| 2022 |
$10 |
Price erosion continues due to increased generic supply |
Current Price Range (2023)
| Price Type |
Price per 10 mL bottle |
Market Notes |
| Wholesale |
$8 - $12 |
NDC 43598-0625 |
| Retail |
$15 - $25 |
With insurance/deductions |
Price Factors
- Generic market saturation drives prices downward.
- Insurance formulary status influences retail prices.
- Manufacturing costs fluctuate with raw material prices, impacting margins.
Market Forecast and Price Projection (Next 5 Years)
Assumptions
- Continued increase in glaucoma prevalence, supporting steady demand.
- Rising adoption of generic drugs with a declining price trend.
- Limited new entries due to patent exclusivity on branded formulations, but significant generic competition.
Price Trajectory
| Year |
Projected Wholesale Price (per 10 mL bottle) |
Key Notes |
| 2024 |
$8.50 |
Slight price decline expected, stabilization expected |
| 2025 |
$8 |
Increased generic penetration stabilizes prices |
| 2026 |
$7.50 |
Competition intensifies, further price erosion |
| 2027 |
$7 |
Market saturation reaches a plateau |
| 2028 |
$6.50 - $7 |
Possible stabilization at lower prices; supply chain efficiencies |
Revenue Impact
- For an estimated 2 million units sold annually in the US, revenue at current prices ($10 per unit) approximates $20 million.
- A 20-30% price decline over five years could reduce revenue to $14 million if volume remains constant.
Regulatory and Policy Influences
- FDA policies: Encouraging biosimilar and generic entry can further lower prices.
- Payor policies: Increasing use of formulary management could limit branded product prescribing.
- International markets: Variations in pricing, especially in countries with price controls, affect global revenue.
Risks and Opportunities
Risks
- Emergence of biosimilars or new drugs may impact market share.
- Policy clampdowns on drug prices could accelerate price declines.
- Supply chain issues affecting manufacturing costs.
Opportunities
- Expansion into emerging markets where treatment rates are rising.
- Development of combination therapies to secure premium pricing.
- Strategic patent filings or exclusivity periods to extend market life.
Conclusion
NDC 43598-0625, as a generic dorzolamide hydrochloride ophthalmic solution, faces ongoing price erosion driven by increased competition. Prices are projected to decline from approximately $10 retail per 10 mL bottle in 2023 to around $6.50–$7 by 2028, assuming current market dynamics persist. Despite downward pressure, the growing prevalence of glaucoma sustains demand, supporting stable revenues albeit at lower margins.
Key Takeaways
- The drug market for NDC 43598-0625 is highly competitive with multiple generics.
- Prices have decreased significantly since 2020, with continued downward trajectory expected.
- Market growth driven by demographic trends offsets some margin compression.
- Regulatory policies and international markets influence pricing and sales volume.
- Opportunities exist for strategic expansion and product differentiation.
FAQs
-
What differentiates NDC 43598-0625 from other glaucoma drugs?
It is a generic, which typically offers lower cost but no clinical differentiation from branded alternatives.
-
How does insurance impact pricing for this drug?
Insurance formulary placement and negotiated rebates significantly influence retail and patient out-of-pocket costs.
-
What are the main competitors for NDC 43598-0625?
Several other generics and branded drugs like Brimonidine and Timolol compete in the same treatment space.
-
Are there patent protections that could delay generic entry?
No, multiple patents on the original molecule have expired, facilitating generic competition.
-
What factors could alter future price projections?
Policy changes, new drug approvals, market entry of biosimilars, and patent litigations could respectively decrease or stabilize prices.
References
- American Academy of Ophthalmology. (2022). Glaucoma prevalence and demographics.
- MarketsandMarkets. (2023). Ophthalmic Drugs Market Report.
- FDA. (2022). List of FDA-approved ophthalmic drugs.
- IQVIA. (2022). The National Prescription Audit.
- PharmaTimes. (2023). Generic drug pricing trends analysis.
