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Last Updated: April 2, 2026

Drug Price Trends for NDC 42385-0921


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Best Wholesale Price for NDC 42385-0921

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 42385-0921

Last updated: February 21, 2026

What is the drug associated with NDC 42385-0921?

NDC 42385-0921 corresponds to Voretigene neparvovec-rzyl (Luxturna), a gene therapy indicated for the treatment of inherited retinal disease caused by mutations in the RPE65 gene. It is approved for patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

How does the current market for Luxturna compare?

Market size and patient population

  • Estimated prevalence of RPE65 mutations: approximately 1,000 to 2,000 U.S. patients.
  • Approvals: First approval granted by the FDA in December 2017.
  • Currently, fewer than 200 patients have been treated in the United States due to the rarity of the condition and high therapy cost.

Competitive landscape

  • No direct gene therapy competitors for RPE65-related disorders.
  • Synonymous or alternative treatments include low vision aids, visual prostheses, and supportive therapies.
  • Other gene therapies in development target different retinal dystrophies but are not directly competitive.

Market dynamics

  • Pricing: Luxturna was initially priced at approximately $850,000 for both eyes (December 2017).
  • Payer response: Payers have negotiated outcomes-based agreements, often limiting the number of patients who can access the therapy.
  • Distribution: Limited centers approved for administration; this restricts the potential patient pool.

What are the pricing trends and projections?

Historical price points

  • Initial launch price: $850,000 for the full treatment course (both eyes).
  • Price adjustments: Few; some negotiated discounts and outcomes-based payments reduce net expenditure.

Price projections over the next five years

Year Estimated List Price per Course Notes
2023 $850,000 Stable price, limited updates
2024 $810,000 - $850,000 Small discounts in negotiated agreements
2025 $780,000 - $850,000 Potential further negotiations, market saturation risk
2026 $750,000 - $830,000 Price containment efforts and competition less likely
2027 $730,000 - $820,000 Slight declines possible due to market evolution

Factors affecting future pricing

  • Market penetration: Growth in treated patients is slow due to disease rarity.
  • Reimbursement policies: Increasing adoption of outcomes-based pricing impacts net price.
  • Manufacturing costs: May decrease modestly over time due to process improvements.
  • Regulatory and policy changes: Potential for price regulation on high-cost therapies.

Revenue assumptions

  • Estimated annual sales in the U.S.: $200 million in 2023, stabilizing as new patients are added slowly.
  • Global sales: Potential to reach $300 million, driven by Europe and Asia-Pacific markets.

What is the outlook for market growth?

  • The gene therapy market for inherited retinal diseases is projected to grow at 10-12% CAGR over the next five years, driven primarily by late adopters and expanded indication approvals.
  • Luxturna's market share could plateau once most eligible patients receive treatment, unless new indications emerge.

Regulatory and policy considerations

  • The FDA approved Luxturna with a soft indication for patients with confirmed biallelic RPE65 mutations, reducing off-label usage.
  • Payer frameworks increasingly tie reimbursement to outcomes, influencing effective market size and profit margins.

Key drivers of future value

  • Long-term efficacy data supporting sustained visual function improvements.
  • Potential expansion to broader inherited retinal dystrophies with similar pathophysiology.
  • Introduction of next-generation gene therapies that might offer lower costs or improved outcomes.

Summary

Aspect Details
Current market size Fewer than 200 U.S. patients treated (2017-present)
Pricing Approximately $850,000 per course (list price)
Future price range $730,000 - $850,000 annually (next five years)
Revenue estimates $200-300 million in global sales (2023-2027)
Market growth potential 10-12% CAGR driven by broader indication and regional expansion

Key Takeaways

  • Luxturna maintains high pricing due to rarity and complex manufacture.
  • Market expansion limited by patient diagnosis and treatment access hurdles.
  • Pricing is expected to stay stable or slightly decline due to negotiations, reimbursement models, and potential competition.
  • Long-term value hinges on sustained efficacy and regulatory developments.

FAQs

  1. What are the key factors influencing Luxturna’s pricing?
    Market exclusivity, manufacturing costs, reimbursement negotiations, and patient population size.

  2. Is there a potential pathway for price reductions?
    Yes, through negotiated outcomes, growth in treated patients, and new entrants reducing manufacturing costs.

  3. How does Luxturna compare to other high-cost gene therapies?
    It is among the most expensive treatments, but its price reflects the rarity of the condition, complex manufacturing, and personalized nature.

  4. What is the potential global market for Luxturna?
    Up to $300 million annually, with uptake dependent on regulatory approvals, healthcare infrastructure, and payer acceptance.

  5. Could new therapies disrupt Luxturna’s market?
    Possible if they offer similar or better efficacy at lower costs, or if gene editing approaches emerge as alternatives.


References

[1] Food and Drug Administration. (2017). FDA approves novel gene therapy to treat patients with inherited retinal disease.
[2] Genentech. (2023). Luxturna Prescribing Information.
[3] Evaluate Pharma. (2023). Gene Therapy Market Trends and Projections.
[4] IQVIA. (2022). Global Market Data for Rare Disease Treatments.
[5] National Eye Institute. (2021). Inherited Retinal Dystrophies Prevalence and Treatment.

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