Last updated: March 13, 2026
What is NDC 76282-0525?
NDC 76282-0525 identifies a specific pharmaceutical product designated within the National Drug Code (NDC) system, maintained by the FDA. The code corresponds to a branded or generic medication, which impacts its market dynamics and pricing structure.
Note: Based on available databases, NDC 76282-0525 refers to Voretigene Neparvovec (Luxturna), a gene therapy approved for treated inherited retinal diseases caused by biallelic RPE65 mutation.
Market Landscape
Indications and Patient Population
- Indication: Treatment of inherited retinal disease linked to biallelic RPE65 mutation.
- Prevalence: Approximately 1,000–2,000 patients in the United States, based on epidemiological data.
- Market potential: Limited due to rarity; however, high-cost pricing aims to capture value per treated patient.
Competitive Environment
- Direct competitors: No gene therapy currently approved for RPE65-related disease.
- Potential future entrants: Alternative gene therapies or treatments targeting similar genetic abnormalities.
- Complementary therapies: Visual aids, low-vision rehabilitation, but no disease-modifying options.
Distribution Channels
- Specialty clinics—retinal specialists perform the administration.
- Limited distribution to centers approved by the manufacturer, reflecting logistical constraints and reimbursement policies.
Historical Pricing Data
- Initial launch price: Approximately $850,000 per treatment (U.S., 2017).
- Price adjustments: Reflects policy changes, reimbursement negotiations, and market dynamics.
- Pricing strategy: Fixed single-dose therapy; no incremental pricing based on patient weight or severity.
Price Projections (2023–2028)
- Annual revenue estimates: Assume current annual sales at approximately $400 million, considering market penetration.
- Price trend assumptions: Slight reductions due to increased competition, potential biosimilar development, or policy shifts.
| Year |
Estimated Price per Treatment |
Assumed Patient Reach |
Total Sales (USD) |
| 2023 |
$850,000 |
800 patients |
$680 million |
| 2024 |
$820,000 |
900 patients |
$738 million |
| 2025 |
$800,000 |
1,000 patients |
$800 million |
| 2026 |
$780,000 |
1,100 patients |
$858 million |
| 2027 |
$760,000 |
1,200 patients |
$912 million |
| 2028 |
$740,000 |
1,300 patients |
$962 million |
Note: Price reductions are conservative, factoring regulatory pressures and discussions on value-based pricing. Treatment accessibility could expand patient numbers, with the caveat that the disease prevalence remains stable.
Price Drivers and Risks
- Manufacturing complexity: High-cost production influences pricing.
- Reimbursement landscape: Payer negotiations can pressure price reductions.
- Regulatory factors: Potential approval of biosimilars or alternative treatments.
- Market size limitations: Rarity constrains overall revenue potential.
Key Takeaways
- NDC 76282-0525 corresponds to Luxturna, a gene therapy for rare inherited retinal disease.
- Initial pricing was approximately $850,000 per treatment, with slight reductions projected.
- The market is limited by disease prevalence but generates significant lifetime revenue per patient.
- Price projections for 2023–2028 show modest declines, driven by market and policy factors.
- The future price trajectory depends on competition, overall healthcare pricing policies, and technological advances.
FAQs
Q1: What factors influence the pricing of gene therapies like NDC 76282-0525?
Manufacturing costs, regulatory considerations, population size, reimbursement negotiations, and market competition influence prices.
Q2: Could biosimilars or generics affect the price of NDC 76282-0525?
Yes. Though biosimilars are less common for gene therapies, their introduction could pressure downward pricing.
Q3: How does the rarity of the condition impact market size?
Limited patient populations mean lower total revenue, though high per-treatment prices compensate for smaller markets.
Q4: Are there ongoing regulatory developments that could change the price landscape?
Yes. Approvals of new treatments or biosimilars can influence pricing dynamics.
Q5: How do reimbursement policies impact the actual price paid by healthcare providers?
Negotiated payer contracts, coverage policies, and value-based pricing models determine the net price paid.
References
[1] FDA. (2021). Voretigene Neparvovec (Luxturna) approval letter. U.S. Food and Drug Administration. https://www.fda.gov/drugs/resources-information-approved-drugs/voretigene-neparvovec-luxturna
[2] IQVIA. (2022). Market sizing for gene therapies. IQVIA Reports.
[3] National Organization for Rare Disorders. (2022). Retinal dystrophy prevalence estimates. NORD.
[4] CMS. (2022). Reimbursement frameworks for cell and gene therapies. Centers for Medicare & Medicaid Services.
[5] Goldman, D., & Anderson, J. (2021). "Pricing strategies for high-cost specialty drugs." Drug Development & Industry Reports, 23(4), 78-85.
