Last updated: February 21, 2026
What is NDC 59651-0782?
NDC 59651-0782 corresponds to Oxbryta (voxelotor), an FDA-approved treatment for sickle cell disease (SCD). Approved in November 2019, Oxbryta is a targeted therapy aimed at reducing hemolysis by inhibiting hemoglobin S polymerization.
Market Overview
Indication and Patient Population
- Primary indication: Sickle cell disease in adults and pediatric patients age 12 and older.
- Prevalence: Estimated at approximately 100,000 Americans with SCD, primarily of African, Mediterranean, Middle Eastern, or Indian ancestry (CDC, 2022). Global prevalence exceeds 20 million, with highest concentrations in sub-Saharan Africa.
Competitive Landscape
-
Current therapies:
- Hydroxyurea (brand: Droxia, Hydrea)
- Endari (L-glutamine)
- Adakveo (crizanlizumab)
- Voxelotor (Oxbryta)
- Crizanlizumab (Adakveo) more on pain crises
-
Market share:
- Hydroxyurea remains standard of care.
- Voxelotor positions as a disease-modifying agent targeting hemolysis.
- Other new therapies are entering the market, potentially affecting dominance.
Regulatory and Reimbursement Status
- FDA approval in Nov 2019.
- In 2020, approved for ages 12+.
- Payer coverage varies but generally includes commercial insurance and Medicaid.
- Orphan drug designation confers certain market exclusivities.
Market Drivers
- Growing awareness of sickle cell disease management.
- Increasing approval of disease-modifying therapies.
- High unmet need, especially in severe cases.
- Ongoing clinical trials extend indications to younger children.
Pricing and Revenue Projections
Current Pricing
- List price: Approximately $115,000 per year for the average adult patient (industry reports, 2023).
- Actual paid prices are typically lower due to negotiations, discounts, and rebates.
Revenue Trends
- Initial sales in 2020 were modest, with estimates of around $10 million.
- Rapid growth projected with expanded indications and increased adoption.
- Industry analysts estimate revenue could reach $500 million to $1 billion annually by 2026, assuming consistent uptake and reimbursement.
Price Projections
| Year |
Estimated Average Price |
Projected Sales (USD) |
Key Assumptions |
| 2023 |
$115,000 |
$50-100 million |
Market penetration of 5-10%, steady growth |
| 2024 |
$110,000 |
$150-250 million |
Broader payer coverage, increased prescribing |
| 2025 |
$105,000 |
$300-500 million |
Expansion into pediatric market, new formulations |
Price reductions may occur due to competitive pressures and payer negotiations.
Challenges and Risks
- Pricing pressures due to healthcare cost containment.
- Competition from emerging therapies.
- Access limitations in low-income regions.
- Patent protection expected to last until at least 2030.
Regulatory and Market Opportunities
- Expansion into pediatric populations.
- Investigation of combination therapies.
- Potential indications in other hemoglobinopathies.
Conclusions
Oxbryta’s market is expanding but remains sensitive to pricing strategies, competitive dynamics, and payer policies. Revenue growth prospects hinge on broader adoption, inclusive reimbursement, and ongoing clinical development.
Key Takeaways
- NDC 59651-0782 (Oxbryta) targets a niche but growing market for SCD.
- Current list pricing is around $115,000 per year; actual revenue is mitigated by discounts.
- Industry projections forecast significant sales increases through 2025-2026.
- Competitive landscape and payer negotiations constitute primary risks.
- Expanding indications and formulations could support long-term market presence.
FAQs
What factors influence the price of Oxbryta?
Reimbursements, manufacturer pricing strategies, payer negotiations, and competition dynamics.
How does Oxbryta compare to other SCD treatments?
It offers a disease-modifying mechanism directly targeting hemolysis, complementing symptom-focused therapies like pain management drugs.
What is the patient eligibility criteria for Oxbryta?
FDA-approved for patients aged 12 and older with sickle cell disease.
Are there off-label uses under consideration?
Clinical trials are exploring its use in other hemoglobinopathies, but off-label prescribing has limited evidence.
What is the potential impact of biosimilars or generics?
Patent protections and market exclusivities delay biosimilar entry until approximately 2030, but lower-cost generics may emerge afterward.
References
- Centers for Disease Control and Prevention (CDC). (2022). Data and statistics on sickle cell disease.
- Industry estimates and projections based on market reports from EvaluatePharma (2023).
- U.S. Food and Drug Administration (FDA). (2019). Oxbryta (voxelotor) approval notice.
- IQVIA Institute. (2023). The Global Use of Medicines in 2023.
