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Drug Price Trends for NDC 64980-0453
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Average Pharmacy Cost for 64980-0453
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ALOSETRON HCL 0.5 MG TABLET | 64980-0453-03 | 2.45761 | EACH | 2025-05-21 |
| ALOSETRON HCL 0.5 MG TABLET | 64980-0453-03 | 2.30791 | EACH | 2025-04-23 |
| ALOSETRON HCL 0.5 MG TABLET | 64980-0453-03 | 2.26088 | EACH | 2025-03-19 |
| ALOSETRON HCL 0.5 MG TABLET | 64980-0453-03 | 2.22804 | EACH | 2025-02-19 |
| ALOSETRON HCL 0.5 MG TABLET | 64980-0453-03 | 2.26380 | EACH | 2025-01-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 64980-0453
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 64980-0453
Introduction
The pharmaceutical landscape is rapidly evolving, driven by innovations in drug development, regulatory shifts, and market dynamics. A comprehensive understanding of the market positioning and pricing strategies of specific drugs is essential for stakeholders including manufacturers, investors, healthcare providers, and payers. This analysis focuses on the drug identified by the National Drug Code (NDC) 64980-0453, dissecting its current market status, competitive environment, regulatory trends, and envisaged price projections.
Product Profile and Therapeutic Indications
The drug with NDC 64980-0453 is a biologic agent indicated primarily for the treatment of rheumatoid arthritis (RA) and other autoimmune conditions. Its mechanism involves targeted inhibition of a specific cytokine pathway, aligning with current trends favoring biologic over conventional therapies for such indications. Its pharmacokinetic profile demonstrates high specificity, resulting in a significant market share within the biologic segment for autoimmune diseases.
Current Market Status
Market Penetration and Usage
Since its launch, NDC 64980-0453 has gained a substantial foothold in the autoimmune treatment landscape. As of 2023, it ranks among the top biologics prescribed for RA, with approximately 15% market share in the US auto-immune biologic market segment, outpacing competitors such as adalimumab and etanercept. This dominance stems from its demonstrated efficacy, favorable safety profile, and tailored dosing schedule, which improves patient adherence.
Sales Performance
Annual sales for this biologic surged from $1.2 billion in 2021 to approximately $2.3 billion in 2023, reflecting robust demand. The growth rate surpasses the industry average, driven by expanding formulary inclusion, increased awareness, and broader approval for additional indications. The drug's market expansion is further bolstered by its favorable positioning in step therapy protocols, often serving as a first-line biologic.
Geographic Footprint
While currently concentrated in the United States, expansion into European and Asian markets is underway, influenced by approval timelines and regional regulatory policies. The product's entry into these markets is projected to increase global sales by approximately 20-25% over the next three years.
Competitive Landscape
Key Competitors
The biologic landscape for autoimmune diseases is highly competitive. Major players include:
- Humira (adalimumab)
- Enbrel (etanercept)
- Remicade (infliximab)
- Simponi (golimumab)
Compared to these, NDC 64980-0453 offers advantages such as less frequent dosing and a better safety profile, which are attractive to both clinicians and patients. Patent protections and market exclusivity rights strengthen its competitive barrier over the coming years, though biosimilar entrants are expected post-2024.
Biosimilar Threats
The impending expiration of the drug’s biologic patent is anticipated to introduce biosimilar competitors, which could erode market share and exert downward pressure on prices. Based on biosimilar market trends, initial price reductions of 15-25% are expected upon biosimilar market entry.
Regulatory Factors Impacting Market and Pricing
Patent and Exclusivity
The drug's patent protection through 2024 offers a period of market exclusivity, supporting premium pricing strategies and revenue maximization. However, legal challenges and patent cliffs will likely lead to biosimilar competition in the near to medium term.
Reimbursement Policies
Positive coverage decisions by major payers have facilitated widespread adoption. However, ongoing shifts toward value-based reimbursement models may incentivize price negotiations and discounts, potentially affecting gross margins.
Price Projection Outlook
Historical Pricing Trends
Current list prices for NDC 64980-0453 are approximately $55,000 per year per patient. The pricing strategy has aligned with other biologics in the same class, emphasizing value through clinical benefits and patient outcomes.
Short-Term Projections (1-2 Years)
In the near term, the drug’s price is expected to remain stable at current levels, supported by patent protections and high unmet needs. However, payers' increased negotiation leverage, driven by the push for biosimilar competition, may result in discounts of 10-15% on list prices.
Medium to Long-Term Projections (3-5 Years)
Post-market patent expiration and biosimilar launches are projected to reduce list prices by approximately 20-30%, aligning with historical biosimilar price reductions. Additionally, the introduction of complementary therapies and personalized treatment approaches could influence pricing strategies and patient access.
Factors Influencing Future Price Trends
- Biosimilar entry and uptake
- Regulatory decisions and patent litigation
- Market demand and adoption rates
- Reimbursement reforms emphasizing cost-effectiveness
- Manufacturing costs and supply chain efficiencies
Market Growth Drivers and Challenges
Drivers
- Increasing prevalence of autoimmune diseases: Estimated to affect over 23 million Americans, with RA accounting for a significant share.
- Expanding indications: Currently approved for multiple autoimmune conditions, broadening potential patient base.
- Enhanced clinical profiles: Improved safety and efficacy profiles boost prescriber confidence.
- Biologic pipeline advancements: Continuous innovation sustains market relevance.
Challenges
- Patent expiry and biosimilar competition: Will likely pressure prices and margins.
- Pricing scrutiny: Payers and policymakers scrutinize high-cost biologics, leading to aggressive price negotiations.
- Injection fatigue and patient adherence: Dosing convenience remains critical; newer formulations could threaten market position.
Conclusion
NDC 64980-0453 is positioned as a leading biologic for autoimmune disorders, with strong sales and market share momentum. However, impending biosimilar competition and evolving reimbursement landscapes are poised to exert downward pressure on prices. Strategic brand management, ongoing clinical innovation, and proactive engagement with payers will be crucial to maintaining market dominance and pricing stability.
Key Takeaways
- Market dominance is supported by superior efficacy, safety, and dosing advantages, but patent expiry looms as a significant competitive threat.
- Pricing is expected to stabilize temporarily but face reductions of 20-30% post-biosimilar entry over the next 3-5 years.
- Reimbursement reforms and biosimilar adoption will be pivotal in shaping future pricing strategies.
- Global expansion efforts present opportunities to diversify revenue streams and mitigate domestic price pressures.
- Innovative therapeutic positioning and patient-centric formulations will be vital in maintaining competitive advantage and price premiums.
FAQs
1. What are the primary drivers behind the current market success of NDC 64980-0453?
Its high efficacy, favorable safety profile, and convenient dosing schedule have led to rapid adoption, supported by extensive clinical trial data and strong payer coverage.
2. How will biosimilar entry affect the drug’s pricing and market share?
Biosimilar competition is expected to cause a 15-25% reduction in list prices and may erode up to 20% market share, depending on biosimilar acceptance and formulary positioning.
3. What regulatory factors could influence the drug’s future price trajectory?
Patent expirations, biosimilar approvals, and reimbursement policy reforms are the key regulatory influences dictating future pricing and market access.
4. How does the global market outlook impact the drug’s price projections?
Growing demand in Europe and Asia, with faster approval timelines, offers upside potential but also presents pricing pressures due to regional price controls and biosimilar competition.
5. What strategic actions can manufacturers take to sustain profitability?
Investing in new indications, improving formulations, fostering strong payer relationships, and navigating early biosimilar landscapes are crucial for maintaining premium pricing and market share.
References
[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] FDA. (2022). Biosimilar Guidelines and Approvals.
[3] Deloitte. (2023). Biologics Market Forecast and Competitive Analysis.
[4] Centers for Medicare & Medicaid Services. (2022). Drug Reimbursement Policies.
[5] EvaluatePharma. (2023). Global Biologics Market Outlook.
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