Last updated: March 2, 2026
What is NDC 00004-0261?
NDC 00004-0261 refers to a specific drug product, which is Respiclick (albuterol sulfate inhalation powder). It is indicated for the treatment of bronchospasm in patients with reversible airway disease, including COPD and asthma. The drug is a dry powder inhaler (DPI) manufactured by Cipla.
Market Size and Demand Drivers
Current Market Landscape
- The global respiratory drugs market was valued at approximately USD 25 billion in 2022.
- The inhaled bronchodilators segment, which includes albuterol formulations, accounts for roughly 25-30% of this market.
- The U.S. market dominates with a share exceeding 50%, driven by high prevalence rates of asthma (approximately 25 million Americans affected) and COPD (around 16 million diagnosed cases).
Competitive Position
NDC 00004-0261 competes with other albuterol inhalers, including:
- MDI (metered-dose inhalers) such as ProAir HFA, Ventolin HFA, and Proventil HFA.
- DPI options like Advair Diskus and Spiriva HandiHaler.
- Recently approved generic versions of albuterol inhalation drugs, which pressurize pricing.
Market Penetration Factors
- Convenience of dry powder inhalers appeals to patients who prefer ease of use.
- Increasing adoption driven by the rise in asthma/COPD prevalence and COPD exacerbations.
- Expanding insurance coverage and formulary inclusion make it accessible to more patients.
- Regulatory approvals for generic versions influence price competition and market share.
Price Trends and Projections
Historical Pricing Data
- Average wholesale price (AWP) for albuterol inhalers has seen a decline from around USD 150 per inhaler in 2018 to approximately USD 90 in 2022.
- The introduction of generics has reduced retail prices, with some formulations selling between USD 50-70 per inhaler.
Current Price Range
- For NDC 00004-0261 (Cipla Respiclick), retail prices range from USD 65 to USD 80 per inhaler.
- Insurance covering reduces out-of-pocket costs to USD 20-40 per inhaler for many patients.
Price Projection Methodology
Projections assume:
- Continued increased adoption of DPIs over MDIs.
- Entry of generic competitors reducing prices by 15-20% annually over the next 3 years.
- Regulatory and patent expiration data from the FDA and patent registries informing timing of generic entry.
Future Pricing Outlook (2023-2026)
| Year |
Projected Average Price (USD) |
Comment |
| 2023 |
USD 62-77 |
Slight price decline, stable demand |
| 2024 |
USD 55-70 |
Increased generic competition |
| 2025 |
USD 50-65 |
Market saturation with generics |
| 2026 |
USD 45-60 |
Lowering due to increased options |
Key Market Dynamics Influencing Prices
- Patent Status: Cipla’s formulation is lacking recent patents, exposing it to generic competition.
- Regulatory Approvals: New generic submissions projected for 2024-2025 could intensify price discounts.
- Market Trends: Growth in telemedicine and home inhalation therapy increases volume but pressures prices due to commoditization.
Investment and Business Implications
- The drug's market shares are vulnerable to rapidly falling prices caused by generics.
- Strategies should incorporate lifecycle management, such as brand differentiation through device design or combination therapies.
- Companies can capitalize on the growing prevalence of asthma and COPD, especially in aging populations and developing markets.
Conclusion
NDC 00004-0261, as a generic or comparable inhaler, faces significant price erosion due to patent expirations and rising competition. Prices are expected to decline steadily over the next three years, with a potential stabilization around USD 45-60 per inhaler by 2026. Market growth hinges on disease prevalence and device adoption, with regulatory milestones influencing competitive dynamics.
Key Takeaways
- The current retail price is USD 65–80 per inhaler.
- Prices are projected to decline by approximately 20-25% over the next three years.
- Generic entry is the primary driver of price reduction.
- Market growth driven by rising asthma and COPD prevalence remains significant.
- Competitive strategies include device innovation and expanding geographic presence.
FAQs
Q1: When will generic versions of this drug likely enter the market?
A1: Expected between 2024 and 2025, based on patent expirations and FDA approvals.
Q2: How does insurance impact patient costs for NDC 00004-0261?
A2: Insurance plans reduce out-of-pocket costs to USD 20-40 for many patients.
Q3: How does the device type affect market adoption?
A3: Dry powder inhalers like Respiclick are preferred for ease of use and portability, supporting adoption over traditional MDIs.
Q4: What are the main competitors to this drug?
A4: MDI-based albuterol inhalers such as ProAir HFA and Ventolin HFA, along with other DPI options.
Q5: What factors could slow price declines?
A5: Regulatory delays, limited generic approval, and supply chain constraints.
References
[1] Global Data. (2022). Respiratory drugs market analysis.
[2] U.S. FDA. (2022). Patent and exclusivity database.
[3] IQVIA. (2022). Market Trends and Price Data Reports.
[4] Statista. (2022). Prevalence of asthma and COPD in the U.S.
[5] Centers for Disease Control and Prevention. (2022). Asthma Surveillance Data.
