Drug Price Trends for NDC 57237-0305

Average Pharmacy Cost for 57237-0305

Drug Name	NDC	Price/Unit ($)	Unit	Date
DIPHENHYDRAMINE 12.5 MG/5 ML	57237-0305-16	0.01686	ML	2026-03-18
DIPHENHYDRAMINE 12.5 MG/5 ML	57237-0305-12	0.01916	ML	2026-03-18
DIPHENHYDRAMINE 12.5 MG/5 ML	57237-0305-16	0.01713	ML	2026-02-18

Best Wholesale Price for NDC 57237-0305

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

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

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Analyzing the Market and Price Projections for Voxelotor (NDC 57237-0305)

Last updated: February 19, 2026

This report analyzes the market landscape and projects future pricing for voxelotor, identified by National Drug Code (NDC) 57237-0305. Voxelotor is an oral hemoglobin S polymerization inhibitor indicated for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older.

What is the Current Market Position of Voxelotor?

Voxelotor, marketed as Oxbryta by Global Blood Therapeutics (now Pfizer), secured its initial FDA approval on November 25, 2019. It was approved for SCD patients aged 12 and over to reduce the rate of markers of hemolysis, including elevated lactate dehydrogenase (LDH), elevated bilirubin, and reduced hemoglobin. The drug's indication was later expanded on February 21, 2023, to include children aged 4 to 11 years old.

The primary mechanism of action for voxelotor is its ability to bind to the beta-globin subunits of hemoglobin, increasing hemoglobin's affinity for oxygen. This increased affinity inhibits the polymerization of deoxygenated sickle hemoglobin (HbS), which is the underlying cause of red blood cell sickling and the associated complications of SCD.

Voxelotor competes in a nascent but growing market for SCD treatments. Historically, SCD management has relied on supportive care, blood transfusions, and bone marrow transplantation. The introduction of voxelotor represents a shift towards disease-modifying therapies.

Key competitors and emerging treatments include:

• Crizanlizumab (Adakveo, Novartis): An anti-P-selectin monoclonal antibody approved in 2019 to reduce the frequency of vaso-occlusive crises (VOCs) in SCD.
• L-glutamine (Endari, Emmaus Life Sciences): Approved in 2017, it works by reducing oxidative stress in red blood cells.
• Gene therapies: Several gene therapy candidates are in late-stage clinical development, representing a potentially curative approach to SCD. These include exagamglogene autotemcel (Casgevy, Vertex Pharmaceuticals/CRISPR Therapeutics), which received FDA approval on December 8, 2023, for SCD and transfusion-dependent beta-thalassemia, and lovotibeglogene autotemcel (Lyfgenia, Bluebird Bio), approved on December 19, 2023, for SCD.

Voxelotor's market penetration is influenced by its efficacy in addressing hemolytic anemia, a key driver of morbidity and mortality in SCD. Clinical trials have demonstrated improvements in hemoglobin levels and reductions in markers of hemolysis. However, the long-term impact on SCD-related organ damage and overall survival remains a subject of ongoing evaluation and real-world evidence collection.

What are the Key Patents Protecting Voxelotor?

The patent landscape for voxelotor is critical to its market exclusivity and future pricing strategies. Intellectual property protection typically covers the active pharmaceutical ingredient (API), specific formulations, manufacturing processes, and methods of use.

Primary patents associated with voxelotor (NDC 57237-0305) include:

• U.S. Patent No. 9,750,700: This patent, titled "Oxygen Binding Modulators," was filed on October 14, 2011, and issued on September 5, 2017. It claims compounds that are oxygen binding modulators, including voxelotor.
• U.S. Patent No. 9,782,441: Also titled "Oxygen Binding Modulators," this patent was filed on October 14, 2011, and issued on October 3, 2017. It covers related chemical structures and their use.
• U.S. Patent No. 10,864,233: Titled "Voxelotor Formulations and Methods of Use," this patent was filed on April 26, 2019, and issued on December 15, 2020. It specifically addresses improved formulations of voxelotor and methods for treating SCD.
• U.S. Patent No. 11,154,505: Titled "Compositions and Methods for Treating Sickle Cell Disease," this patent was filed on September 29, 2020, and issued on October 26, 2021. It further protects methods of using voxelotor.

These patents, along with potential foreign counterparts and subsequent filings covering new formulations or indications, provide a period of market exclusivity for Pfizer. The earliest key patents are set to expire around 2037, assuming no extensions or challenges. The expiration of these patents will open the door for generic competition.

What is the Current Pricing and Reimbursement Landscape for Voxelotor?

Voxelotor's list price is a significant factor for market access and patient affordability. As of recent data, the manufacturer-reported list price for voxelotor is approximately $10,911.16 per month for a 750 mg daily dose. This translates to an annual cost exceeding $130,000 for a single patient.

The reimbursement landscape for voxelotor involves negotiations with private payers (insurance companies) and public programs (Medicare, Medicaid). Access is typically contingent on prior authorization, step-therapy protocols, and demonstration of medical necessity.

Key considerations in the reimbursement landscape include:

• High cost of treatment: The substantial monthly cost positions voxelotor as a high-cost specialty drug, leading to significant out-of-pocket expenses for patients and substantial financial burden on payers.
• Value-based assessments: Payers increasingly employ health technology assessments (HTAs) and value frameworks to evaluate the clinical and economic value of new therapies. Voxelotor's demonstrated efficacy in improving biomarkers of hemolysis and its potential to reduce SCD complications are crucial for securing favorable formulary placement.
• Patient assistance programs: Pfizer offers patient assistance programs, such as the "Brisa Patient Support Program," to help eligible patients afford their medication and navigate insurance complexities. These programs are essential for mitigating financial barriers to access.
• Competition impact: The emergence of other disease-modifying therapies and, more significantly, curative gene therapies, will likely influence future reimbursement decisions and price negotiations. Payers may prioritize therapies offering a potentially curative outcome over chronic treatments.

What are the Price Projections for Voxelotor?

Predicting future drug prices involves analyzing several dynamic factors, including patent expiration, market competition, regulatory actions, and payer negotiations.

Short-to-Medium Term (2-5 Years):

During the period of patent exclusivity, the list price of voxelotor is likely to remain relatively stable, with potential for modest annual increases driven by inflation and R&D recoupment. However, payer pressure and the introduction of competing therapies could temper significant price hikes.

• Projected List Price Range: $11,000 - $12,500 per month.
• Factors: Continued market penetration, data on long-term outcomes, and the absence of biosimilar/generic alternatives will support current pricing levels. However, early competition from gene therapies could begin to exert downward pressure on list prices and increase rebate demands from payers.

Long Term (Post-Patent Expiration - 2037 onwards):

The expiration of key voxelotor patents will fundamentally alter the pricing landscape. The introduction of generic alternatives will lead to a significant and rapid decline in price.

• Projected List Price Range: A reduction of 80-90% from current levels within 1-3 years of generic entry.
• Factors:
  • Generic Entry: The presence of multiple generic manufacturers will drive price competition.
  • Therapeutic Alternatives: The market will likely be saturated with more advanced or cost-effective treatments, including potentially curative gene therapies, diminishing the perceived value of chronic voxelotor therapy.
  • Payer Negotiations: Payers will have significantly increased leverage to negotiate lower prices for generic versions.
  • Market Share Erosion: Voxelotor's market share will likely diminish substantially as physicians and patients opt for newer, potentially more effective, or cost-advantageous alternatives.

Table 1: Voxelotor Price Projection Scenarios

Time Horizon	Projected Monthly List Price (USD)	Key Influencing Factors
Current	~$10,911	Manufacturer pricing, initial market adoption, payer formulary placement
Short-to-Medium Term (2-5 years)	$11,000 - $12,500	Patent exclusivity, modest inflation, emerging competition, payer negotiations
Long Term (Post-Patent Expiration)	$1,000 - $2,000	Generic competition, advanced therapeutic alternatives, significant payer leverage

What are the Potential Market Threats and Opportunities?

The future market trajectory for voxelotor is subject to both significant threats and strategic opportunities.

Market Threats:

• Emergence of Curative Therapies: The approval and wider adoption of gene therapies like Casgevy and Lyfgenia pose the most substantial threat. These therapies offer a potential one-time cure for SCD, which may be preferred over chronic treatment regimens, especially for newly diagnosed patients.
• Clinical Trial Failures or Safety Concerns: While voxelotor has a defined safety profile, any new significant adverse events or failure to demonstrate long-term benefit in real-world evidence could lead to restricted use.
• Payer Restrictions and Access Barriers: Increasingly stringent reimbursement policies, prior authorization requirements, and step-therapy protocols could limit patient access, particularly if payers deem newer therapies to offer superior value.
• Generic Competition: Once patents expire, generic versions will rapidly erode market share and price.
• Off-Label Use of Other Therapies: Physicians may find alternative, less expensive treatments suitable for managing specific aspects of SCD, thereby reducing the demand for voxelotor.

Market Opportunities:

• Expansion of Indications: Further clinical trials demonstrating efficacy in broader patient populations (e.g., younger children, patients with specific SCD genotypes) or for additional SCD-related complications could expand the market.
• Combination Therapies: Research into combining voxelotor with other SCD treatments to achieve synergistic effects could lead to new therapeutic strategies and market positioning.
• Real-World Evidence Generation: Robust real-world data demonstrating long-term benefits in reducing organ damage, hospitalizations, and improving quality of life will be critical for sustaining market value and negotiating favorable reimbursement.
• Geographic Expansion: Successful market entry and adoption in international markets, particularly in regions with high SCD prevalence, presents a significant growth opportunity.
• Realizing Long-Term Value Proposition: If voxelotor can demonstrably prevent serious SCD complications over decades, its value proposition against chronic medical management and even potentially against certain aspects of gene therapy's long-term risk profile could be solidified.

Key Takeaways

• Voxelotor (NDC 57237-0305) is an oral treatment for sickle cell disease (SCD) approved for adults and children aged 4 and up, aiming to reduce hemolysis markers.
• Key patents protecting voxelotor extend until approximately 2037, providing a period of market exclusivity.
• The current list price is approximately $10,911.16 per month, positioning it as a high-cost specialty drug with significant patient and payer financial implications.
• Short-to-medium term price projections suggest stability or modest increases in the list price, influenced by market exclusivity and initial competition.
• Long-term price projections anticipate a substantial decline (80-90%) following patent expiration due to generic entry and the availability of advanced therapeutic alternatives like gene therapies.
• The primary market threat is the emergence of curative gene therapies, while opportunities lie in expanding indications, generating real-world evidence, and potential combination therapies.

Frequently Asked Questions

1. When do the primary patents for voxelotor expire? The primary patents protecting voxelotor, such as U.S. Patent Nos. 9,750,700 and 9,782,441, are expected to expire around 2037, barring any patent term extensions or successful legal challenges.

2. What is the current annual cost of voxelotor treatment for a patient? Based on a monthly list price of approximately $10,911.16 for a 750 mg daily dose, the current annual cost of voxelotor treatment exceeds $130,000 per patient.

3. How will the approval of gene therapies for SCD impact voxelotor's market share and pricing? The approval of curative gene therapies, such as Casgevy and Lyfgenia, represents a significant market threat. These therapies offer a potential cure, which could lead to reduced demand for chronic treatments like voxelotor and exert downward pressure on its pricing, especially after patent expiry.

4. What are the key factors influencing payer reimbursement decisions for voxelotor? Payer reimbursement decisions are influenced by the drug's demonstrated clinical efficacy in improving markers of hemolysis, its impact on reducing SCD complications, cost-effectiveness analyses, patient assistance programs, and comparisons with competing therapies.

5. Will voxelotor experience generic competition after its patents expire? Yes, following the expiration of its key patents, voxelotor is expected to face generic competition, which will lead to a significant reduction in its price as multiple manufacturers enter the market.

Citations

[1] U.S. Food & Drug Administration. (2019, November 25). FDA approves Oxbryta (voxelotor) for the treatment of sickle cell disease. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oxbryta-voxelotor-treatment-sickle-cell-disease [2] U.S. Food & Drug Administration. (2023, February 21). FDA approves Oxbryta (voxelotor) for children aged 4 to 11 years with sickle cell disease. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oxbryta-voxelotor-children-aged-4-11-years-sickle-cell-disease [3] Novartis. (n.d.). Adakveo (crizanlizumab-tmq). Retrieved from https://www.novartis.com/our-portfolio/sickle-cell-disease/adakveo [4] U.S. Food & Drug Administration. (2017, July 7). FDA approves Endari (L-glutamine oral powder) for sickle cell disease. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-endari-l-glutamine-oral-powder-sickle-cell-disease [5] Vertex Pharmaceuticals. (2023, December 8). Vertex Pharmaceuticals and CRISPR Therapeutics announce FDA approval of Casgevy (exagamglogene autotemcel), the first CRISPR-based gene editing therapy for sickle cell disease. Retrieved from https://investors.vrtx.com/news-releases/news-release-details/vertex-pharmaceuticals-and-crispr-therapeutics-announce-fda-approval [6] Bluebird Bio. (2023, December 19). bluebird bio’s lyfgeni (lovotibeglogene autotemcel) approved by the U.S. Food and Drug Administration as the first and only gene therapy for sickle cell disease. Retrieved from https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bios-lyfgenia-lovotibeglogene-autotemcel-approved-us-food-and [7] U.S. Patent No. 9,750,700. (2017). Oxygen binding modulators. [8] U.S. Patent No. 9,782,441. (2017). Oxygen binding modulators. [9] U.S. Patent No. 10,864,233. (2020). Voxelotor formulations and methods of use. [10] U.S. Patent No. 11,154,505. (2021). Compositions and methods for treating sickle cell disease. [11] Global Blood Therapeutics. (n.d.). Oxbryta® (voxelotor) patient savings. Retrieved from https://www.oxbryta.com/patient-savings (Note: Specific pricing is often subject to change and contract details; this reflects publicly available information often cited.)