Last updated: February 16, 2026
Overview
NDC 00574-7226 refers to a specific drug formulation, identified in the National Drug Code (NDC) directory. Precise insights depend on the drug's active ingredient, formulation, and indication. For this assessment, this NDC corresponds to Roflumilast (Daliresp), a phosphodiesterase-4 inhibitor used for chronic obstructive pulmonary disease (COPD).
Market Landscape
-
Roflumilast's market size has historically grown due to increasing COPD prevalence globally. The global COPD treatment market was valued at approximately $9.3 billion in 2022 and is projected to reach around $11.7 billion by 2028, with a CAGR of 3.8% (Source: Business Insider Intelligence).
-
The drug competes primarily with inhaled bronchodilators and corticosteroids. Roflumilast offers an oral alternative for patients intolerant to inhalers, though it faces competition from other oral COPD therapies.
-
Prescriber adoption hinges on its safety profile — notably, gastrointestinal side effects and neuropsychiatric adverse events can limit usage.
-
Key markets include the United States, Europe, and Japan. The U.S. accounts for roughly 50% of sales, driven by high COPD prevalence (11.5 million diagnosed cases, CDC, 2022).
Pricing Trends
-
Current U.S. wholesale acquisition cost (WAC) for a 30-day supply (30 tablets of 500 mcg) is approximately $385 (Sources: SSR Health, 2022).
-
Average out-of-pocket costs after insurance may range from $30 to $80, depending on formulary positioning.
-
In Europe, Price levels for Roflumilast vary: Germany reports prices around €45 per 30-tablet pack (~$50), reflecting local reimbursement policies.
Price Projections
-
Short-term outlook: Prices are likely to remain stable or slightly decrease as generic competition emerges. The patent for Daliresp expired in 2021, with generics entering the market in 2022.
-
Generic introductions generally lead to a decrease of 40–60% in wholesale prices within the first year, depending on market penetration (Source: IQVIA).
-
Long-term projections suggest a further price drop driven by increased generic competition and formulary negotiations:
-
In 2023–2024: retail prices could decline by approximately 50%, bringing the cost per 30-day supply to about $190.
-
By 2026–2028: prices may stabilize around $100–$150 in the U.S., with variations based on payer negotiations and market share.
-
Pricing in international markets depends on local approval, patent status, and pricing regulations, generally trending downward after patent expiry, with some markets experiencing price controls that limit increases.
Forecast Assumptions
-
Patent expiry in the U.S. and EU in 2021-2022 facilitates market entry of generics.
-
Reimbursement policies continue favoring generic substitution.
-
The clinical adoption rate stabilizes, with prescriptions adjusted for tolerability and side effect profiles.
-
No major new competitors or indications emerge within the forecast period.
Risks and Opportunities
-
Risks: Market erosion from generics, increased competitive marketing, potential new therapies with superior efficacy or safety.
-
Opportunities: Expanded indications (e.g., asthma management), formulation improvements, tailored dosing strategies, and strategic partnerships with payers.
Summary
The drug corresponding to NDC 00574-7226 (likely Roflumilast) experienced patent expiry, leading to rapid price declines driven by generic entry. Prices are expected to continue decreasing, with estimates indicating a 50–60% reduction within the next two years. Market size expansion hinges on increasing COPD prevalence, prescriber acceptance, and competitive positioning against inhaled therapies.
Key Takeaways
-
Roflumilast's total market is approximately $2.5 billion globally, with the U.S. accounting for roughly half.
-
Current wholesale price is ~$385/month; generic competition is expected to cut prices to ~$190/month by 2024.
-
International prices fluctuate but generally trend downward post-patent expiry.
-
Market growth remains steady but faces substitution pressure from inhalers and emerging therapies.
-
Future revenues depend on patent negotiations, formulary positioning, and potential new indications.
FAQs
1. What are the primary competitors for Roflumilast?
Inhaled bronchodilators such as long-acting beta-agonists (LABAs) and inhaled corticosteroids dominate the COPD treatment market. Oral therapies like Tiotropium are alternatives, but Roflumilast offers a different mechanism.
2. How do patent timelines affect future pricing?
Patent expiration in 2021-2022 permits generic competition, which historically reduces prices by 40–60% within the first year and stabilizes further decreases over subsequent years.
3. What factors influence international pricing?
Regulatory approval, reimbursement policies, market demand, and patent status affect pricing. European markets tend to set lower prices due to government-regulated prices.
4. Are there any new formulations or indications in development?
Current efforts are focused on expanding COPD management. No significant new formulations or additional indications are yet approved.
5. How does prescriber acceptance impact market share?
Prescriber familiarity, side effect profiles, and comparative efficacy influence adoption rates, directly affecting sales volume and revenue.
References
[1] Business Insider Intelligence, "Global COPD Treatment Market," 2022.
[2] CDC, "COPD Prevalence and Diagnosis," 2022.
[3] SSR Health, "Prescription Drug Pricing Data," 2022.
[4] IQVIA, "Generic Drug Market Trends," 2022.
