Last updated: February 24, 2026
What is the drug identified by NDC 81284-0411?
NDC 81284-0411 refers to Roflumilast (Daliresp), a selective phosphodiesterase-4 inhibitor approved by the U.S. Food and Drug Administration (FDA) for reducing the risk of COPD exacerbations in adults with severe COPD associated with chronic bronchitis and a history of exacerbations.
Current Market Size and Usage
The COPD drug market in the U.S. was valued at approximately $4.5 billion in 2020, with Roflumilast accounting for estimated sales of $230 million. Based on market share and current prescribing trends, Roflumilast maintains a modest position primarily prescribed as an add-on therapy for severe COPD patients with frequent exacerbations.
Patient Population
- Total COPD patients in the U.S.: ~15 million
- Severe COPD with chronic bronchitis: approximately 40%
- Patients eligible for Roflumilast (severe COPD + frequent exacerbations): around 2 million
- Annual prescriptions: estimated 1 million, reflecting moderate adoption
Market Dynamics Influencing Price and Usage
Competitive Landscape
- Main alternatives: Long-acting bronchodilators (LABAs, LAMAs), inhaled corticosteroids (ICS)
- Pricing: Roflumilast has a list price of approximately $350–$400 for a 30-day supply (30 tablets)
Regulatory and Prescribing Trends
- The medication's use remains limited due to side effects (weight loss, gastrointestinal issues)
- Increasing awareness of COPD management guidelines has the potential to expand usage
- No significant patent expiry risks; however, the arrival of biosimilars or new competitors could pressure prices
Insurance and Reimbursement
- Insurance coverage is generally favorable, but copayments can range from $15–$50 per month depending on patient assistance programs
- The drug's formulary placement influences patient access and provider prescribing behavior
Price Projections
Short-term (Next 1-2 Years)
- Stable pricing expected, with slight fluctuations driven by inflation and rebate negotiations
- Average wholesale price (AWP): $400/month
- Net price after rebates and discounts likely around $250–$300/month
Medium-term (3-5 Years)
- Potential for a 10–15% price reduction if biosimilars or generics advance or if reimbursement strategies tighten
- With increased adoption, volume-driven revenue may offset price erosion
Long-term (Beyond 5 Years)
- Price erosion could accelerate if new oral COPD therapies enter the market that demonstrate superior efficacy or safety
- If patent protections remain, prices could sustain, but competition may limit growth
Revenue Forecasts
| Year |
Prescriptions |
Average Price (per month) |
Estimated Sales (USD millions) |
| 2023 |
1 million |
$350 |
$4.2 billion (market-wide) |
| 2024 |
1.2 million |
$340 |
$4.9 billion (market-wide) |
| 2025 |
1.5 million |
$330 |
$5.3 billion (market-wide) |
Note: These estimates depend on broader COPD market growth, evolving prescribing practices, and competitive entry.
Key Factors Impacting Market and Pricing
- The introduction of new COPD therapies with improved safety profiles
- Changes in clinical guidelines promoting wider use
- Patent protections and market exclusivity periods
- Reimbursement policies favoring cost-effective treatments
Key Takeaways
- Roflumilast maintains a niche role within the COPD treatment landscape, with growth primarily dependent on increased adoption among appropriate patient subsets.
- Price remains relatively stable with minor declines expected over the next few years, influenced mainly by market competition and payer negotiations.
- The total addressable market is projected to grow modestly, driven by increased recognition of severe COPD management needs.
- Future pricing and revenue growth hinge on competitive dynamics, regulatory shifts, and emerging therapeutic options.
FAQs
1. What factors could lead to significant price drops for NDC 81284-0411?
Introduction of biosimilars or generics, regulatory changes reducing reimbursement rates, or a shift to more effective alternatives could lower prices.
2. How does prescribing behavior influence market size for Roflumilast?
Increased guideline adoption and awareness among pulmonologists can expand prescriptions, leading to higher sales volume without significantly affecting price.
3. Are there any patent protections preventing generic entry?
As of early 2023, patents protecting Roflumilast remain active in the U.S., providing exclusivity through at least the late 2020s.
4. What role do payer strategies play in drug pricing?
Payers negotiate rebates and discounts that lower net prices, impacting profitability more than list prices.
5. How might new therapies impact the market in the next five years?
New oral or inhaled drugs with superior efficacy, safety, or reduced side effects may cannibalize Roflumilast sales, exerting downward pressure on prices.
References
- IQVIA. (2022). Pharmaceutical Market Reports and Insights.
- U.S. Food and Drug Administration. (2020). Drug Approvals and Labeling.
- Centers for Disease Control and Prevention. (2021). Chronic Obstructive Pulmonary Disease (COPD) Statistics.
- GoodRx. (2023). Drug Price Comparisons.
- EvaluatePharma. (2022). World Market Outlook for COPD Drugs.
