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Drug Price Trends for daliresp
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Average Pharmacy Cost for daliresp
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DALIRESP 250 MCG TABLET | 00310-0088-39 | 14.57827 | EACH | 2025-11-19 |
| DALIRESP 500 MCG TABLET | 00310-0095-90 | 14.56273 | EACH | 2025-11-19 |
| DALIRESP 250 MCG TABLET | 00310-0088-28 | 14.57827 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Market Analysis and Price Projections for Daliresp (Roflumilast)
Introduction
Daliresp (generic name: roflumilast) is a prescription medication primarily used to manage severe chronic obstructive pulmonary disease (COPD). Approved by the U.S. Food and Drug Administration (FDA) in 2011, Daliresp offers a novel phosphodiesterase-4 (PDE4) inhibitor mechanism, aimed at reducing exacerbations and improving lung function in COPD patients. As the global COPD market expands due to increasing prevalence and aging populations, understanding Daliresp's market dynamics and pricing trajectory is crucial for stakeholders—including pharmaceutical companies, investors, healthcare payers, and policy makers. This analysis provides a comprehensive overview of Daliresp's current market position, competitive landscape, and future pricing forecasts.
Market Landscape for COPD and Daliresp
Global COPD Market Overview
COPD remains a leading cause of morbidity and mortality worldwide, with an estimated 200 million affected individuals and approximately 3 million deaths annually [1]. The disease’s economic burden exceeds $50 billion annually in the U.S. alone, driven by direct healthcare costs and lost productivity. The increasing prevalence correlates with aging populations, tobacco use, environmental pollution, and occupational exposures.
The COPD therapeutic landscape is marked by bronchodilators (anticholinergics and beta-agonists), corticosteroids, and combination inhalers. Recently, the focus has shifted toward more disease-modifying therapies like roflumilast, especially for patients with severe disease and frequent exacerbations.
Market Position of Daliresp
Daliresp holds a niche in the COPD treatment paradigm, particularly indicated for patients with a history of exacerbations associated with chronic bronchitis and severe airflow limitation. Its unique mechanism as a PDE4 inhibitor differentiates it from inhaled bronchodilators and corticosteroids, offering an oral alternative that complements existing therapies.
Market penetration has been gradual. Despite its approved benefits, Daliresp's adoption has been constrained by factors such as:
- Side effects: Gastrointestinal issues, weight loss, and neuropsychiatric disturbances.
- Cost considerations: Oral formulation tends to be more expensive than inhaled therapies.
- Physician familiarity and clinical guidelines: Adoption remains cautious due to limited real-world efficacy data and safety profile considerations.
As of 2022, Daliresp accounted for approximately 2-3% of the total COPD market share by revenue in the U.S. [2].
Competitive Landscape
Existing Therapies and Their Market Share
The COPD market is highly competitive, dominated by inhaled therapies:
- Long-acting muscarinic antagonists (LAMAs): Tiotropium (Spiriva), umeclidinium.
- Long-acting beta-agonists (LABAs): Salmeterol, formoterol.
- Combination inhalers: Fluticasone/salmeterol (Advair), tiotropium/olodaterol.
These inhaled regimens enjoy broader acceptance due to their rapid onset and established efficacy. However, Daliresp’s role is adjunctive for high-risk subpopulations, resulting in steady but relatively modest sales growth.
Emerging Competitors and Pipeline Drugs
Recent pipeline development focuses on biologics and new oral agents targeting inflammation and airway remodeling. Although no direct PDE4 competitors currently threaten Daliresp, future pipeline compounds may vie for similar niche markets if they demonstrate superior efficacy and tolerability.
Market Forecasts and Price Projection
Historical Sales and Pricing Data
- 2018: Daliresp generated approximately $210 million globally [3].
- 2019-2020: Sales plateaued, reflecting modest adoption.
- 2021-2022: Slight uptick due to aging population and increased COPD awareness, reaching around $230-250 million.
Pricing: The average wholesale price (AWP) for Daliresp in the U.S. hovers near $300-$350 per month (per patient), considering typical dosing (500 mcg once daily). Price discounts and insurance negotiations reduce net prices for payers, but the medication remains relatively costly.
Pricing Drivers and Constraints
- Regulatory factors: Price controls and formulary restrictions influence net pricing.
- Market competition: Availability of generic alternatives could influence future pricing—however, as of now, Daliresp remains under patent exclusivity.
- Clinical value: The perceived incremental benefit over existing therapies impacts willingness to pay. Improved patient adherence and reduced exacerbation rates could justify premium pricing.
Future Price Projection (2023-2030)
Considering current trends, patent expirations, and market dynamics:
-
Short-term (2023-2025):
Expect a gradual price stabilization with minor reductions due to increased competition from potential generics if patent challenges succeed—although patent protection is robust until 2028-2029. Patient access programs and rebates are likely to sustain pharmacy acquisition costs near current levels. -
Mid-term (2026-2028):
Potential patent expirations could lead to pricing erosion. Introduction of biosimilars or generics may reduce prices by 20-40%. Manufacturers might respond with value-based pricing and bundled therapy discounts. -
Long-term (2029 onwards):
Price declines could reach 50% of current levels if generics capture significant market share. Conversely, if new indications or combination therapies enhance Daliresp’s profile, premium pricing could persist in niche segments, stabilizing annual revenues at $100-150 million.
Factors Influencing Future Pricing
-
Patent Lifecycle and Patent Challenges: The key patents for Daliresp last until around 2028-2029. Patent challenges may accelerate generic entry or result in settlement agreements, affecting pricing.
-
Regulatory Approvals and Label Expansion: Additional indications (e.g., asthma or other inflammatory lung diseases) could extend market exclusivity and support price premiums.
-
Market Penetration and Physician Adoption: Increased clinical adoption could justify price premiums through demonstrated real-world benefits.
-
Healthcare Policy and Reimbursement Trends: Moves toward value-based healthcare and price negotiations will heavily influence net prices.
-
Competitive Innovations: Emergence of more efficacious, better-tolerated oral agents or combination therapies could further pressure Daliresp prices.
Conclusion
Daliresp remains a specialized yet modest contributor to COPD management, with a stable but competitive market position. Its pricing is susceptible to patent life, clinical utility, and competitive forces. Short-term prospects suggest stable prices, while mid- to long-term projections hinge on patent status, regulatory developments, and pipeline innovations. Stakeholders should monitor regulatory timelines and market entry strategies to optimize economic outcomes.
Key Takeaways
- Daliresp's current annual sales approximate $230 million, with a niche but stable market share in COPD therapy.
- Price points remain around $300-$350/month but are vulnerable to patent expirations and generic competition post-2028.
- Market growth is constrained by side effects, cost, and physician preference for inhaled therapies, but a role persists in high-risk populations.
- Future pricing will be driven by patent protection, clinical evidence expansion, and competitive dynamics, with potential declines in the 40-50% range if generics gain significant market share.
- Strategic positioning around value-based pricing, indication expansion, and improved safety profiles will be critical for sustaining Daliresp’s market relevance.
FAQs
1. When will Daliresp face generic competition?
Patent protections are projected to expire around 2028-2029, after which generic versions, if approved, could significantly lower prices.
2. How does Daliresp compare cost-wise to inhaled COPD therapies?
Daliresp's monthly cost (~$300-$350) exceeds that of many inhaled bronchodilators, which typically range from $150-$250, although drug pricing varies by insurer and rebates.
3. Are there any upcoming clinical trials that could influence Daliresp's market?
Current trials focus on expanding indications and improving safety profiles. Successful results could enhance its market position and justify premium pricing.
4. What factors could hinder Daliresp's market growth?
Side effects, safety concerns, and increasing acceptance of combination inhalers remain barriers to widespread adoption.
5. Is Daliresp suitable for all COPD patients?
No. It is generally reserved for patients with severe COPD and frequent exacerbations who are intolerant or unresponsive to inhaled therapies.
References
[1] World Health Organization. "Chronic obstructive pulmonary disease (COPD)." WHO, 2022.
[2] IQVIA. "Pharmaceutical Market Reports," 2022.
[3] EvaluatePharma. "Global COPD Market Data," 2021.
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