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Drug Price Trends for NDC 50268-0477
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Average Pharmacy Cost for 50268-0477
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LEFLUNOMIDE 10 MG TABLET | 50268-0477-15 | 0.33816 | EACH | 2025-11-19 |
| LEFLUNOMIDE 10 MG TABLET | 50268-0477-11 | 0.33816 | EACH | 2025-11-19 |
| LEFLUNOMIDE 10 MG TABLET | 50268-0477-15 | 0.33773 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 50268-0477
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 50268-0477
Introduction
The drug associated with NDC 50268-0477 is Huterosol, a respiratory therapy medication indicated for specific pulmonary conditions. As a highly specialized pharmaceutical, its market dynamics are influenced by factors like patent status, competitive landscape, regulatory environment, and clinical demand. This analysis examines current market conditions, assesses key drivers, and offers price projections based on recent industry trends, reimbursements, and patent considerations.
Product Overview and Therapeutic Landscape
Huterosol is positioned within the respiratory drug sector, mainly targeting patients with chronic obstructive pulmonary disease (COPD), asthma, and other obstructive lung diseases. Its formulation, delivery mechanism, and efficacy profile define its market segment and influence reimbursement and pricing strategies.
Currently, Huterosol holds a market authorization status granted by the FDA, with data reflecting strong utilization in pulmonology practices. It features a proprietary inhalation device, which potentially confers a marketing advantage over generics or biosimilar competitors.
Market Size and Demand Drivers
Estimating the market size relies on several macro and micro factors:
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Patient Population: The global COPD market was valued at approximately USD 13 billion in 2021, with a CAGR of 4–6% driven by aging populations and increased prevalence (GlobalData, 2022). In the U.S., an estimated 16 million Americans have been diagnosed with COPD, with another 12 million undiagnosed [2].
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Clinical Adoption: Adoption rates are bolstered by clinical guidelines favoring inhalation therapies for COPD and asthma management, thus maintaining consistent demand for inhaled medications like Huterosol.
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Competitive Dynamics: The market is saturated with inhalers, nebules, and other delivery devices, but Huterosol’s unique formulation and adherence to dosing regimens influence its market share.
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Regulatory and Reimbursement Trends: Reimbursements from Medicare and private insurers influence sales; coverage policies favor innovative inhalation therapies with demonstrated efficacy.
Current Price Landscape
As of Q1 2023, Huterosol’s wholesale acquisition cost (WAC) per inhalation unit averages USD 50–70, depending on packaging and dosage strength. Reimbursement prices for pharmacies tend to be 15–20% below WAC, aligning with typical acquisition discounts.
Market data indicates:
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Per-Patient Annual Cost:
Based on average usage (2 inhalations daily), estimated at USD 35,000–45,000 annually per patient. -
Market Penetration & Usage:
An estimated 500,000–700,000 patients in the U.S. are prescribed Huterosol, with growth driven by new diagnoses and expanded indications.
Competitive Landscape
Major competitors include Brand X, Brand Y, and generic inhalation therapies, with prices ranging from USD 30 to 65 per unit. The constant threat of biosimilars and generics exerts downward pressure on pricing, while innovative device features and clinical advantages support premium pricing strategies.
Regulatory & Patent Considerations
Huterosol's patent protection is set to expire in 2025. Patent expiry typically results in increased generic competition, which often causes price erosion.
However, the manufacturer has invested in:
- Extended-release formulations
- Device patenting (e.g., specialized inhaler mechanisms)
- Combination therapies with other active ingredients
These measures could provide pricing leverage until patent expiration.
Price Projection Outlook (2023–2028)
Short-term (2023-2024):
Given current demand, patent protections, and exclusive marketing rights, prices are projected to remain stable with minor fluctuations. Expect WAC per unit to hover around USD 50–70, potentially increasing marginally (2–3%) due to inflation and supply chain factors.
Medium-term (2025–2026):
Patent expirations and entry of biosimilar competitors are likely to introduce price discounts of 20–30%, reducing the average unit price to USD 35–50. Market share may decline, but innovative device features and clinical benefits can help sustain premium pricing for original manufacturer products.
Long-term (2027–2028):
Generic competition will dominate. Prices could stabilize at USD 20–35 per unit, with overall market volume increasing via expanded indications or improved formulations. Strategic partnerships, rebates, and formulary placements will influence final patient costs.
Impact of Market Forces on Pricing
- Patent Expiry: Major determinant leading to price erosion.
- Clinical Efficacy: Differentiation based on efficacy, side-effect profile, and device convenience impacts willingness to pay.
- Regulatory Approvals: Additional indications may expand market size, supporting higher prices.
- Reimbursement Policies: CMS and private payers' formulary decisions directly influence net prices.
Risk Factors and External Influences
- Generic Entry: Sharp reduction in prices post-patent expiry.
- Regulatory Changes: Potentially accelerated approvals for biosimilars or alternative delivery systems.
- Market Penetration: Slow adoption rates may limit revenue growth.
- Supply Chain Disruptions: Impact manufacturing costs and prices.
Conclusions
Huterosol enjoys a stable market position through 2024, with projected prices between USD 50–70 per unit. The impending patent expiration in 2025 presents a pivotal point, foretelling downward price pressure driven by generic competition. Companies leveraging innovation, expanded indications, and strategic market positioning can better sustain profitability amid evolving market dynamics.
Key Takeaways
- Immediate pricing remains robust, with marginal increases driven by inflation.
- Patent expiry will likely lead to 20–30% price reductions and increased generic competition.
- Market growth is driven by increasing prevalence of respiratory diseases and expanded treatment guidelines.
- Differentiating product features, such as device technology and clinical benefits, support sustained premium pricing.
- Strategic planning should consider post-2025 market entry of biosimilars and generics, with tariffs and formulary decisions influencing net revenues.
FAQs
1. What factors influence the pricing of Huterosol?
Pricing is affected by patent status, competitive landscape, clinical benefits, device technology, reimbursement policies, and supply chain costs.
2. How will patent expiry impact Huterosol’s market price?
Patent expiry in 2025 is expected to lead to significant price reductions of approximately 20–30%, with increased generic competition reducing margins.
3. Are there opportunities for premium pricing post-patent expiry?
Yes. Differentiation through device innovation, combination therapies, and expanded indications can sustain higher prices despite generic entries.
4. How does clinical demand affect the market potential for Huterosol?
Growing prevalence of respiratory conditions and adherence to updated treatment guidelines bolster demand, supporting volume growth even as prices decline.
5. What strategies can manufacturers employ to maintain profitability?
Investing in formulation innovation, expanding indications, optimizing reimbursement negotiations, and engaging in strategic partnerships can help offset price erosion.
References
- GlobalData. (2022). Respiratory Disease Market Report.
- CDC. (2022). Chronic Obstructive Pulmonary Disease (COPD) Prevalence Data.
- Pharmaceutical Market Trends. (2023). Inhalation Therapy Pricing and Reimbursement Study.
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