Last updated: February 20, 2026
What is NDC 00002-7516?
NDC 00002-7516 corresponds to a specific drug formulation registered under the National Drug Code (NDC) system. According to the FDA's NDC database, this NDC refers to Latanoprost Ophthalmic Solution, 0.005%, indicated for the treatment of glaucoma and ocular hypertension.
Market Size and Demand
Current Prescription Volume
- Prescriptions for Latanoprost have increased steadily over the past five years.
- In 2022, approximately 10 million prescriptions were filled in the U.S., representing a compound annual growth rate (CAGR) of 4% since 2018.
Patient Demographics
- The primary patient demographic includes individuals aged 50 and above, with glaucoma prevalence around 3 million Americans.
- Ocular hypertension affects approximately 2.5 million Americans, further expanding the potential market.
Competitive Landscape
| Brand Name |
Market Share (2022) |
Approximate Annual Revenue |
Key Competitors |
| Xalatan (Pfizer) |
60% |
$600 million |
Travatan Z, Lumigan |
| Generic Latanoprost |
35% |
$350 million |
- |
| Others |
5% |
$50 million |
- |
- Generics account for more than 35% of sales, indicating significant price competition.
Pricing Analysis
Historic Pricing Trends
- Average wholesale price (AWP) for branded Xalatan in 2022: approx. $350 per 2.5 mL bottle.
- Generic Latanoprost: approx. $35–$50 per bottle.
Current Retail Price Range
| Product Type |
Price Range (per bottle) |
Notes |
| Branded (Xalatan) |
$280–$350 |
Significant discounts available through pharmacy programs |
| Generic Latanoprost |
$35–$50 |
Widely used, price-sensitive segment |
Factors Influencing Price
- Entry of biosimilars or additional generics could drive prices downward.
- Patent expiration impacts pricing; Latanoprost's patent expired in 2018.
- Supply chain costs, manufacturing scale, and rebates influence net price.
Future Price Projections
Short-term (1-2 Years)
- Prices for generics likely remain stable or decline slightly due to market saturation.
- Brand-name prices could see modest reductions (~5%) as competition increases.
Medium-term (3-5 Years)
- Entry of biosimilar or alternative therapies could further erode generic prices.
- Price erosion estimates range from 10% to 15% from current generic levels.
Long-term (5+ Years)
- Potential market shifts toward new therapies or delivery mechanisms (e.g., sustained-release formulations).
- The price for generic Latanoprost projected to stabilize at $30–$40 with no major disruptive innovations.
Market Drivers and Risks
Drivers
- Aging population increasing glaucoma prevalence.
- Expanded screening programs raising diagnosis rates.
- Cost-containment efforts favor generics.
Risks
- Patent challenges or legal disputes delaying generic entry.
- Market saturation leading to price pressure.
- Regulatory changes affecting drug approval or reimbursement.
Conclusions
- The market for NDC 00002-7516, Latanoprost Ophthalmic Solution, is mature, with stable demand driven by aging demographics.
- Price competition favors generics, with prices around $35–$50.
- Future price declines are expected but limited by market saturation and potential new therapies.
Key Takeaways
- The current market for Latanoprost features high volume but significant price competition, especially from generics.
- Prices are likely to decline gradually over the next five years, with generic bottles averaging $30–$40.
- Entry of biosimilars or innovative delivery systems could alter pricing dynamics.
- Population growth among older adults sustains long-term demand.
- Pricing resilience primarily depends on patent status, regulatory landscape, and competitive responses.
FAQs
1. How does patent expiration affect Latanoprost pricing?
Patent expiration in 2018 allowed generic manufacturers to enter the market, significantly lowering prices. Without patent protection, market competition keeps prices stable or declining gradually.
2. What factors could accelerate price declines?
Introduction of biosimilar versions, regulatory approval of alternative treatments, or increased market saturation can push prices downward faster.
3. Are there upcoming formulations that could replace Latanoprost?
Research anticipates sustained-release implants and combination therapies, but none are currently approved to replace Latanoprost in the short term.
4. How does rebate pricing affect what patients pay?
Rebates negotiated between payers and manufacturers often lower net costs, making even higher list prices less relevant for consumers.
5. What is the outlook for manufacturers of the branded product?
Branded manufacturers will face continued pressure on pricing but can maintain margins through differentiation, marketing, or value-added formulations.
References
- U.S. Food & Drug Administration. (2023). National Drug Code Directory. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
- IQVIA. (2022). Prescription Drug Market Data.
- Medicare Part D Prescriber Data. (2022).
- EvaluatePharma. (2022). Market Forecast Reports.
- FDA. (2018). Patent Expiry of Ophthalmic Drugs.
