Introduction to Daliresp
Daliresp, with the NDC code 0310-0088, is a prescription drug containing the active ingredient roflumilast, used primarily for the treatment of chronic obstructive pulmonary disease (COPD). It was approved by the FDA in 2011 and is marketed by AstraZeneca Pharmaceuticals LP[5].
Market Context
Global Prescription Drug Market Trends
The global prescription drug market is characterized by high growth rates, particularly in the U.S. market. However, this growth is largely driven by higher prices rather than increased volume. For instance, prescription drug prices in the U.S. are significantly higher than in other OECD countries and the rest of the world, with prices being 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world[4].
U.S. Market Specifics
In the U.S., the prescription drug market has seen substantial revenue growth, especially in the biologic products segment. For example, biologic product sales revenues grew by 61% in the U.S., contrasting with declines in other regions[4].
Pricing and Access Issues
Current Pricing Challenges
Pricing and access to drugs are significant issues in the life sciences industry. The high prices of prescription drugs, including those like Daliresp, are a major concern for patients, insurers, and policymakers. The U.S. market, in particular, faces criticism for its high drug prices compared to other countries[3].
Recent Price Negotiation Initiatives
The Biden-Harris administration has initiated price negotiations for certain high-cost drugs under Medicare, which could set a precedent for broader price reforms. While Daliresp is not among the first 10 drugs selected for this program, such initiatives indicate a growing trend towards price regulation and negotiation[2].
Daliresp Specifics
Market Position and Usage
Daliresp is used to treat COPD, a condition affecting millions worldwide. The drug's market position is influenced by its efficacy, side effect profile, and competition within the COPD treatment market. Given its approval in 2011, Daliresp has established itself as a treatment option, though it faces competition from other COPD treatments[5].
Price Dynamics
The price of Daliresp, like many other prescription drugs, is subject to various factors including production costs, market demand, regulatory environment, and competition. As of the latest data, there is no specific indication that Daliresp's price will be directly affected by the Medicare price negotiation program. However, broader industry trends and regulatory changes could influence its pricing in the future.
Price Projections
Short-Term Projections
In the short term, the price of Daliresp is unlikely to see significant reductions unless it is included in future rounds of Medicare price negotiations or if there are changes in the market dynamics such as the introduction of generic or biosimilar alternatives. Given the current regulatory environment, prices are likely to remain stable or see modest increases in line with inflation and industry trends.
Long-Term Projections
Long-term price projections for Daliresp are more uncertain and depend on several factors:
- Generic and Biosimilar Competition: If generic or biosimilar versions of roflumilast are approved, this could significantly reduce the price of Daliresp.
- Regulatory Changes: Broader regulatory changes aimed at reducing prescription drug prices could impact Daliresp's pricing.
- Market Competition: The introduction of new COPD treatments could also influence the pricing strategy for Daliresp.
Impact of Industry Trends
Digital Transformation and Innovation
The life sciences industry is undergoing significant transformation driven by digital advancements and scientific innovations. While these trends are more likely to impact the development of new drugs rather than the pricing of existing ones, they could lead to more efficient production processes and potentially lower costs in the long run[3].
Patent Cliff and M&A Activities
The biopharma industry is facing a substantial loss of exclusivity due to expiring patents, which could lead to increased competition from generics and biosimilars. This trend may drive interest in mergers and acquisitions, which could also impact the pricing and market position of drugs like Daliresp[3].
Consumer and Patient Impact
Out-of-Pocket Costs
High drug prices, including those of Daliresp, significantly affect patients' out-of-pocket costs. Initiatives like the $2,000 cap on out-of-pocket spending for Medicare beneficiaries and the negotiation of lower drug prices under Medicare can provide relief to patients but may not directly impact Daliresp unless it is included in such programs[2].
Key Takeaways
- Market Trends: The U.S. prescription drug market is characterized by high prices and significant revenue growth, particularly for biologic products.
- Pricing Challenges: High drug prices remain a major issue, with initiatives like Medicare price negotiations aiming to reduce costs.
- Daliresp Market Position: Daliresp is an established treatment for COPD but faces competition and potential future price pressures from generics, biosimilars, and regulatory changes.
- Price Projections: Short-term prices are likely stable, while long-term projections depend on factors like generic competition, regulatory changes, and market dynamics.
FAQs
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What is Daliresp used for?
- Daliresp is used for the treatment of chronic obstructive pulmonary disease (COPD).
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Who manufactures Daliresp?
- Daliresp is manufactured by AstraZeneca Pharmaceuticals LP.
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What are the potential side effects of Daliresp?
- Common side effects include diarrhea, nausea, and serious adverse reactions such as atrial fibrillation and lung cancer.
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How does the Medicare price negotiation program affect Daliresp?
- Currently, Daliresp is not included in the Medicare price negotiation program, but broader industry trends and future regulatory changes could impact its pricing.
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What are the long-term price projections for Daliresp?
- Long-term price projections depend on factors such as generic competition, regulatory changes, and market dynamics, which could lead to price reductions or stability.
Cited Sources
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National Drug Code Database Background Information - FDA
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FACT SHEET: Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation
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2025 life sciences outlook | Deloitte Insights
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ISSUE BRIEF - ASPE
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Label: DALIRESP- roflumilast tablet - DailyMed
