Market Analysis and Price Projections for NDC 76282-0676: CINACALCET by Exelan Pharmaceuticals, Inc.
Introduction
The pharmaceutical industry is a complex and dynamic market, influenced by various factors including regulatory changes, technological advancements, and economic trends. This analysis focuses on the market and price projections for CINACALCET, a drug with the NDC code 76282-0676, manufactured by Exelan Pharmaceuticals, Inc.
Overview of CINACALCET
CINACALCET is a calcimimetic agent used primarily for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and hypercalcemia in patients with parathyroid carcinoma[1].
Market Trends in the Pharmaceutical Industry
The pharmaceutical industry is undergoing significant transformations driven by digital innovation, regulatory pressures, and changing market dynamics.
- Pricing and Access: Pricing and access to drugs are major concerns for the industry. Executives expect these issues to significantly impact their strategies in 2025, with nearly half anticipating a significant impact and another 49% expecting a moderate impact[3].
- Generic and Biosimilar Competition: The rise of generic drugs and biosimilars is a key trend, with 37% of respondents viewing this as a top concern. The patent cliff, where high-revenue products lose exclusivity, is also a significant issue, with over $300 billion in sales at risk through 2030[3].
Pricing Dynamics
Pricing in the pharmaceutical market is highly variable and influenced by several factors.
- Global Price Disparities: The average price per unit in the U.S. is significantly higher than in other regions. For example, prices in the U.S. are 5.5 times those in the OECD (excluding the U.S.) and 7.7 times those in the rest of the world (excluding the U.S.)[4].
- Price Increases: Between 2017 and 2022, the U.S. saw an average price increase of 14%, while prices in the OECD (excluding the U.S.) and the rest of the world decreased by 9% and 7%, respectively[4].
Specific Pricing for NDC 76282-0676
For CINACALCET, specific pricing data is crucial for market analysis.
- Current Pricing: As of the latest available data, detailed pricing for CINACALCET under NDC 76282-0676 is not provided in the sources. However, general trends suggest that prices for branded drugs like CINACALCET tend to be higher in the U.S. compared to other regions[4].
- Wholesale and Pharmacy Costs: For other drugs manufactured by Exelan Pharmaceuticals, such as PREGABALIN (NDC 76282-0572), the average pharmacy cost can vary significantly over time. For instance, the price per unit for PREGABALIN has fluctuated between $0.04937 and $0.07225 per unit in recent months[2].
Price Projections
Given the current market trends and pricing dynamics, here are some projections for CINACALCET:
- Short-Term Projections: In the short term, prices for CINACALCET are likely to remain stable or see moderate increases, aligning with the overall trend of rising drug prices in the U.S.[4].
- Long-Term Projections: Long-term projections are more complex due to the potential impact of generic competition and biosimilars. If a generic version of CINACALCET is approved, prices could drop significantly. However, if the drug maintains its patent exclusivity, prices may continue to rise, albeit at a slower rate due to regulatory and market pressures[3].
Competitive Landscape
The competitive landscape for CINACALCET includes other treatments for secondary hyperparathyroidism and hypercalcemia.
- Branded vs. Generic: The entry of generic versions of CINACALCET could significantly alter the market dynamics, reducing prices and market share for the branded version[3].
- Biosimilars: Although CINACALCET is a small molecule drug and not a biologic, the broader trend of biosimilar competition in the pharmaceutical industry highlights the potential for future competition from similar therapeutic agents[3].
Regulatory Environment
Regulatory changes can significantly impact the pricing and availability of drugs.
- FDA Approvals: Any changes in FDA regulations or approvals for generic or biosimilar versions of CINACALCET could affect its market position and pricing[3].
- Reimbursement Policies: Changes in reimbursement policies by health insurance providers and government programs can also influence the demand and pricing of CINACALCET[4].
Conclusion
The market analysis and price projections for CINACALCET (NDC 76282-0676) are influenced by a combination of factors including global pricing trends, regulatory pressures, and the competitive landscape.
Key Takeaways
- Pricing Trends: Prices for CINACALCET are likely to remain high in the U.S. compared to other regions.
- Regulatory Impact: FDA approvals and changes in reimbursement policies can significantly affect the market.
- Competitive Landscape: The potential entry of generic versions could reduce prices and market share.
- Long-Term Projections: Prices may stabilize or increase moderately in the short term but could drop significantly if generic competition emerges.
FAQs
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What is CINACALCET used for?
CINACALCET is used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and hypercalcemia in patients with parathyroid carcinoma.
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Why are drug prices higher in the U.S.?
Drug prices in the U.S. are higher due to a combination of factors including higher prices for the same drugs, a drug mix that skews towards more expensive compounds, and different regulatory and reimbursement environments compared to other regions[4].
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How does the patent cliff affect drug prices?
The patent cliff, where high-revenue products lose exclusivity, can lead to the entry of generic and biosimilar competitors, which typically results in lower prices for the affected drugs[3].
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What role do regulatory changes play in drug pricing?
Regulatory changes, such as FDA approvals for generic or biosimilar versions, and changes in reimbursement policies, can significantly impact the pricing and availability of drugs like CINACALCET[3].
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How does the competitive landscape affect CINACALCET pricing?
The competitive landscape, particularly the potential entry of generic versions, can reduce prices and market share for the branded version of CINACALCET[3].
Sources
- FindACode: EXELAN PHARMACEUTICALS, INC. - List of Drugs - NDC Labeler.
- DrugPatentWatch: Latest drug prices and trends for NDC 76282-0572.
- Deloitte Insights: 2025 life sciences outlook.
- ASPE: ISSUE BRIEF - International Market Size and Prices.
