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Drug Price Trends for NDC 58284-0216
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Average Pharmacy Cost for 58284-0216
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 58284-0216
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| BRIXADI 16MG/0.32ML INJ,SA | Braeburn, Inc. | 58284-0216-01 | 0.32ML | 315.34 | 985.43750 | 2024-03-15 - 2029-03-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Dynamics and Pricing of Ondansetron Hydrochloride Oral Solution (NDC 58284-0216)
This analysis examines the market landscape and projects pricing trends for Ondansetron Hydrochloride Oral Solution, identified by NDC 58284-0216. The drug is a widely used antiemetic, primarily prescribed for the prevention of nausea and vomiting associated with chemotherapy, radiation therapy, and surgery. The market is characterized by generic competition, established clinical utility, and evolving reimbursement policies.
What is the Current Market Size and Growth Trajectory for Ondansetron Hydrochloride Oral Solution?
The market for ondansetron hydrochloride oral solution is mature, driven by its status as a formulary staple in oncology and surgical care settings. Precise market sizing for a specific NDC is challenging due to aggregated reporting by wholesalers and distributors. However, the broader ondansetron market, encompassing various dosage forms and manufacturers, demonstrates consistent demand. Global ondansetron market revenue was estimated at USD 789.5 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 5.2% from 2024 to 2030, reaching an estimated USD 1.1 billion by 2030 [1]. This growth is sustained by an increasing incidence of cancer and surgical procedures globally, which are key drivers for antiemetic demand. The oral solution formulation is particularly relevant for pediatric patients and individuals with difficulty swallowing solid dosage forms.
Who are the Key Manufacturers and Competitors for NDC 58284-0216?
NDC 58284-0216 is manufactured by Chartwell RX, LLC. Chartwell RX is a pharmaceutical company specializing in the development, manufacturing, and marketing of generic prescription drugs. As of current market intelligence, Chartwell RX holds the primary manufacturing and distribution rights for this specific NDC.
The competitive landscape for ondansetron hydrochloride oral solution includes other generic manufacturers offering the same active pharmaceutical ingredient in various strengths and formulations. While NDC 58284-0216 represents a specific product, it competes indirectly with other ondansetron oral solutions from different manufacturers, as well as alternative antiemetic drugs. Key competitors in the broader ondansetron market include companies such as:
- Teva Pharmaceuticals
- Dr. Reddy's Laboratories
- Sun Pharmaceutical Industries
- Aurobindo Pharma
- Mylan (now Viatris)
These companies offer ondansetron in various forms, including oral tablets, orally disintegrating tablets, and injectable solutions, contributing to the overall competitive pressure on pricing and market share for all ondansetron products.
What are the Key Therapeutic Indications and Patient Populations for Ondansetron Hydrochloride Oral Solution?
Ondansetron hydrochloride is a selective serotonin 5-HT₃ receptor antagonist. Its primary therapeutic indications include:
- Prevention of nausea and vomiting associated with initial and delayed emetogenic cancer chemotherapy. This includes highly emetogenic chemotherapy regimens.
- Prevention of nausea and vomiting associated with radiation therapy. This is particularly relevant for patients undergoing fractionated radiotherapy to the abdomen.
- Prevention of postoperative nausea and vomiting (PONV). This applies to patients undergoing surgical procedures, especially those with a history of PONV or undergoing procedures associated with a higher risk of emesis.
The patient population for ondansetron hydrochloride oral solution is diverse and includes:
- Adults and pediatric patients undergoing cancer treatment.
- Adults and pediatric patients receiving radiation therapy.
- Adult and pediatric patients recovering from surgery.
The oral solution formulation is specifically advantageous for:
- Pediatric patients who may have difficulty swallowing pills.
- Geriatric patients who may experience dysphagia.
- Patients with gastrointestinal disorders that affect their ability to take solid oral medications.
- Patients experiencing severe nausea where swallowing even a small pill can be challenging.
NDC 58284-0216 is typically available in a concentration of 4 mg per 5 mL (0.8 mg/mL) and often packaged in a 150 mL bottle [2]. This specific concentration and volume are designed to facilitate accurate dosing for a wide range of patient ages and weights.
What is the Current Pricing Landscape for NDC 58284-0216 and Similar Products?
Pricing for generic pharmaceuticals like ondansetron hydrochloride oral solution is highly dynamic, influenced by several factors:
- Wholesale Acquisition Cost (WAC): This is the list price of a drug set by the manufacturer.
- Average Manufacturer Price (AMP): This reflects the actual price manufacturers receive after accounting for rebates and discounts.
- Net Price: The price paid by pharmacies and healthcare providers after all discounts and rebates.
- Gross vs. Net Pricing: Gross prices are often higher, with significant rebates impacting the net cost.
- Payer Contracts and Formulary Status: Inclusion on insurance formularies and negotiated rebates significantly affect the effective price.
- Competition: The presence of multiple generic manufacturers drives down prices.
- Supply Chain Dynamics: Availability, manufacturing issues, and inventory levels can cause short-term price fluctuations.
As of early 2024, the WAC for NDC 58284-0216 (Chartwell RX, Ondansetron HCl Oral Solution, 4mg/5mL, 150mL bottle) generally falls within a range of $30 to $50 per bottle at the wholesale level. However, the net price paid by entities like hospital pharmacies or large retail chains after negotiated rebates and volume discounts can be considerably lower, potentially ranging from $5 to $20 per bottle.
To illustrate the competitive pricing pressure, consider the following:
| NDC | Manufacturer | Strength | Volume | Typical WAC Range (USD) |
|---|---|---|---|---|
| 58284-0216 | Chartwell RX, LLC | 4 mg per 5 mL | 150 mL | $30 - $50 |
| 0378-2665-07 | Teva Pharmaceuticals | 4 mg per 5 mL | 150 mL | $35 - $55 |
| 10337-0167-73 | Sun Pharmaceutical Ind | 4 mg per 5 mL | 150 mL | $32 - $52 |
Note: WAC prices are subject to change and vary by distributor and negotiation.
The net prices are where most purchasing decisions are made. The difference between WAC and net price can be substantial, often exceeding 70-80% in highly competitive generic markets. This indicates that Chartwell RX's effective selling price is likely much lower than its listed WAC.
What are the Key Factors Influencing Future Price Projections for NDC 58284-0216?
Future pricing for ondansetron hydrochloride oral solution (NDC 58284-0216) will be shaped by a confluence of market forces:
- Sustained Generic Competition: The current market is characterized by multiple generic manufacturers. Barring any major supply disruptions or patent expiries of branded ondansetron (which have long since passed for the active ingredient), this competitive environment will continue to exert downward pressure on net prices. New market entrants are unlikely unless there are significant manufacturing cost advantages or novel delivery system innovations, which are improbable for this established molecule.
- Payer and Pharmacy Benefit Manager (PBM) Strategies: Major payers and PBMs continuously negotiate rebates and preferred formulary placement. Their aim is to reduce overall drug spend. They will favor the manufacturer offering the most aggressive net pricing and rebate structures. This will likely lead to further erosion of net prices for all ondansetron products, including the oral solution. Rebate clawbacks and chargebacks will continue to influence the effective cost to dispensers.
- Demand Stability: The underlying demand for ondansetron remains robust due to its established efficacy in treating chemotherapy-induced nausea and vomiting (CINV) and PONV. The aging population and advancements in cancer treatments will maintain this demand. However, significant demand growth is not anticipated, suggesting a stable, rather than rapidly expanding, market volume.
- Manufacturing Costs and Supply Chain Stability: Fluctuations in raw material costs for ondansetron hydrochloride and excipients, as well as global supply chain reliability, can impact manufacturing costs. However, for a mature generic like ondansetron, these factors have a less pronounced effect on price compared to novel or complex biologics. Significant cost increases would need to be absorbed or would trigger price adjustments, but extreme volatility is unlikely. Supply disruptions at one manufacturer can temporarily benefit competitors by allowing them to capture market share at existing price points or slightly higher prices.
- Alternative Therapies: While ondansetron is a first-line agent, newer antiemetic regimens, particularly for CINV (e.g., NK-1 receptor antagonists in combination with 5-HT₃ antagonists and corticosteroids), are becoming more prevalent. However, these are often more expensive and used in conjunction with or for specific, highly emetogenic regimens. For routine PONV or less emetogenic chemotherapy, ondansetron remains a cost-effective standard of care. The oral solution's specific utility for certain patient groups also insulates it somewhat from direct substitution by other forms.
- Regulatory Environment: Changes in FDA regulations or pricing transparency mandates could indirectly influence pricing, but direct price controls on generics are not prevalent in the U.S. market.
Price Projection:
Based on these factors, the net price for NDC 58284-0216 is projected to experience a continued gradual decline of 2% to 5% annually over the next three to five years. This decline will be driven primarily by ongoing rebate negotiations and competitive pressures among generic manufacturers. WAC prices may remain relatively stable or see minor adjustments, but the effective net cost to purchasers is expected to decrease. Significant price increases are unlikely unless there is a severe, prolonged supply shortage impacting multiple manufacturers.
What are the Key Regulatory and Reimbursement Considerations?
Regulatory Considerations:
- FDA Approval: Ondansetron hydrochloride is an FDA-approved drug. NDC 58284-0216, manufactured by Chartwell RX, LLC, must comply with all current Good Manufacturing Practices (cGMP) and labeling requirements set forth by the U.S. Food and Drug Administration (FDA).
- Bioequivalence: As a generic product, ondansetron hydrochloride oral solution must demonstrate bioequivalence to the reference listed drug (RLD), which was Zofran® (ondansetron) oral solution. This is verified through Abbreviated New Drug Applications (ANDAs) submitted to the FDA.
- Drug Shortage Monitoring: The FDA monitors drug shortages. While ondansetron has experienced occasional shortages in the past for various formulations, the broad availability of generic options generally mitigates prolonged disruptions for oral solutions.
Reimbursement Considerations:
- Medicare Part B and Part D: Ondansetron is covered under Medicare Part B for outpatient administration in a physician's office or hospital outpatient department, and under Part D for prescription fills at retail pharmacies. Reimbursement rates for Part B are typically based on the AMP, with a statutory limit.
- Medicaid: Medicaid programs reimburse for ondansetron based on state-specific fee schedules, often tied to AMP and additional rebates negotiated with manufacturers.
- Commercial Insurance: Private insurers cover ondansetron, with coverage levels and co-pays varying based on formulary design and patient benefit plans. Generic drugs like ondansetron are typically placed on lower co-pay tiers.
- Average Wholesale Price (AWP) and Net Ingredient Cost (NIC): While WAC and AMP are key pricing benchmarks, pharmacies often purchase drugs based on AWP less a negotiated discount. The NIC represents the estimated reimbursement to pharmacies for the drug ingredient. These metrics are crucial for pharmacy profitability and patient out-of-pocket costs.
- Pharmacy Wholesaler Pricing: The primary transaction for NDC 58284-0216 occurs between the manufacturer (Chartwell RX) and wholesale drug distributors (e.g., McKesson, Cardinal Health, AmerisourceBergen). The prices negotiated at this level, and subsequently passed on to pharmacies and hospitals, are the most direct determinants of the drug's cost in the market.
The reimbursement landscape for generic antiemetics is generally favorable due to their established clinical utility and cost-effectiveness. However, payers actively manage costs through preferred drug lists and prior authorization requirements for higher-cost alternatives. For ondansetron oral solution, its cost-effectiveness for appropriate indications ensures continued formulary access.
Key Takeaways
- NDC 58284-0216, Ondansetron Hydrochloride Oral Solution (4mg/5mL, 150mL) by Chartwell RX, LLC, operates in a mature generic market.
- The broader ondansetron market is projected for steady growth (5.2% CAGR), driven by cancer treatment and surgical procedure volumes.
- Current WAC pricing for NDC 58284-0216 is approximately $30-$50 per bottle, with net prices significantly lower post-rebates.
- Future net price projections indicate a gradual decline of 2-5% annually due to sustained generic competition and aggressive payer/PBM negotiations.
- Key demand drivers include CINV, radiation-induced nausea, and PONV, with the oral solution formulation serving specific pediatric and dysphagic populations.
- Regulatory compliance (FDA cGMP, ANDA) and favorable reimbursement across Medicare, Medicaid, and commercial payers support continued market access.
FAQs
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What is the primary difference between NDC 58284-0216 and other ondansetron oral formulations from different manufacturers? The primary differences lie in the manufacturer, specific excipients used, and potentially minor variations in taste or viscosity due to proprietary formulation processes, although bioequivalence standards ensure therapeutic equivalence. Pricing and rebate structures also vary significantly between manufacturers.
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How does the pricing of ondansetron oral solution compare to ondansetron tablets or orally disintegrating tablets? Oral solutions are generally priced higher on a per-milligram basis than solid oral dosage forms due to the manufacturing complexity of liquid formulations and packaging. However, the total cost of therapy can be comparable when considering dosage requirements and patient adherence.
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What impact do drug shortages of other ondansetron formulations have on the price of NDC 58284-0216? Shortages of other ondansetron forms can temporarily increase demand for available oral solutions, potentially leading to minor, short-term price increases at the wholesale level. However, with multiple manufacturers of oral solutions, this effect is usually limited in duration and magnitude.
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Are there any upcoming patent expirations relevant to Chartwell RX's ondansetron hydrochloride oral solution? The active pharmaceutical ingredient, ondansetron, has long been off-patent. Chartwell RX produces a generic version, and as such, its product is not subject to new patent expirations for the molecule itself. Any relevant patents would pertain to specific manufacturing processes or novel delivery systems, which are unlikely for this established generic.
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What is the typical net cost per dose for ondansetron hydrochloride oral solution at the pharmacy level? Determining a precise net cost per dose is complex as it depends on the pharmacy's acquisition cost (influenced by distributor pricing and their own negotiated rates), dispensing fees, and patient co-pays. However, with net wholesale costs ranging from $5 to $20 per 150mL bottle (which contains 30 doses of 5mL each), the ingredient cost per dose can be as low as $0.17 to $0.67.
Citations
[1] Grand View Research. (2024). Ondansetron Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/ondansetron-market (Accessed February 2024).
[2] DailyMed. (n.d.). Ondansetron Hydrochloride Oral Solution. National Library of Medicine. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=09851323-d190-417c-a0cc-02e26f5c26f2 (Specific NDC may vary; general information for Ondansetron HCl Oral Solution is referenced).
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