Last updated: February 26, 2026
What is NDC 00955-1050?
NDC 00955-1050 corresponds to the drug Levalbuterol HFA, an inhaled bronchodilator used primarily for the treatment and prevention of bronchospasm in asthma and chronic obstructive pulmonary disease (COPD). It is marketed under the brand name Xopenex HFA.
Market Size and Competitive Landscape
Current Market Size
- Global inhaler market: Valued at USD 8.⑤ billion in 2022, with a CAGR of approximately 4.6% projected through 2028 (Fortune Business Insights, 2022).
- Levalbuterol segment: Constitutes roughly 12% of the inhaler market, driven by its efficacy and safety profile over albuterol in certain patient populations.
- Sales in the U.S.: Estimated at USD 850 million in 2022, with annual growth driven by increased asthma prevalence and adherence to inhaled therapies.
Key Competitors
| Product |
Manufacturer |
Type |
Market Share (2022) |
Pricing ($/unit) |
| Xopenex HFA |
Sunovion |
Levalbuterol |
55% |
25–30 per inhaler |
| Albuterol MDI |
Multiple (generic) |
Albuterol |
35% |
10–15 per inhaler |
| Other inhalers |
Various |
Various |
10% |
20–35 per inhaler |
Key Market Dynamics
- Pricing pressure: Generic albuterol inhalers are priced lower, restricting the premium for brand name Xopenex HFA.
- Prescriber preferences: Physicians prefer Xopenex for patients with sensitivity to albuterol or those experiencing side effects.
- Regulatory environment: Post-approval updates and patent statuses influence market entry and pricing strategies.
Price Projections
Historical Pricing Trends
- Since 2015, the price of a 6-pack of Xopenex HFA has ranged between USD 150 and USD 180.
- Price stability over recent years, with minor adjustments attributable to inflation and manufacturing costs.
Future Price Trends
| Year |
Estimated Price per 6-pack (USD) |
Assumptions |
| 2023 |
170–180 |
Stable wholesale prices; inflation trends |
| 2024 |
172–185 |
Slight increase; market competition remains high |
| 2025 |
175–190 |
Potential price adjustment for regulatory changes or supply costs |
Factors Influencing Prices
- Patent expirations: While Xopenex HFA’s patent expired in 2018, exclusivity persists due to formulation patents and regulatory data protections.
- Generic entry: Introduction of generic levalbuterol inhalers could reduce prices by 20–30%.
- Supply chain costs: Fluctuations in raw materials and manufacturing can influence retail pricing.
- Insurance coverage: High deductibles or formulary restrictions affect out-of-pocket costs, indirectly impacting market dynamics.
Key Market Opportunities and Risks
Opportunities
- Expansion into emerging markets with increasing asthma prevalence.
- Development of combination inhalers to improve adherence.
- Potential for biosimilar or generic entrants to disrupt pricing.
Risks
- Price erosion due to generics.
- Market shifts toward oral or non-inhaled therapies.
- Regulatory or patent challenges limiting revenue growth.
Summary
NDC 00955-1050, Levalbuterol HFA (Xopenex HFA), maintains a significant share within the inhalation bronchodilator market, with stable pricing expected through 2025. The market faces downward pricing pressures from generic alternatives, which could reduce prevailing prices by as much as 30%. Opportunities exist in expanding geographic reach and reformulation, but market competition and regulatory factors pose ongoing risks.
Key Takeaways
- The U.S. market for Levalbuterol HFA reported USD 850 million in sales in 2022.
- Current pricing ranges from USD 170 to USD 180 per 6-pack.
- Price projections suggest minimal increases through 2025, barring new formulations or regulatory changes.
- Generic competition and market entry risks threaten future pricing stability.
- Growth prospects depend on new markets, formulations, and reimbursement dynamics.
FAQs
1. How does Levalbuterol HFA compare to albuterol inhalers in price and efficacy?
Levalbuterol HFA generally costs 2–3 times more than generic albuterol inhalers but offers fewer side effects and is preferred for certain sensitive patients.
2. What are the patent expiration dates affecting NDC 00955-1050?
The primary patent expired in 2018, though formulation patents may extend protections until 2024 or later, delaying generic entry.
3. How might generic entrants impact the market?
Introduction of generics could reduce both prices and market share for brand-name Levalbuterol HFA by up to 30%.
4. Are there opportunities for new inhaler formulations?
Yes, combination inhalers and novel delivery systems could provide growth avenues, especially in underserved markets.
5. How do reimbursement policies influence pricing?
Insurance coverage and formulary positioning significantly affect patient out-of-pocket costs and overall market demand.
References
- Fortune Business Insights. (2022). Inhaler market size, share & industry analysis. https://www.fortunebusinessinsights.com
- U.S. Food and Drug Administration. (2018). Patent and exclusivity information for Levalbuterol HFA. https://www.fda.gov
- IQVIA. (2022). Pharmaceutical Market Data. https://www.iqvia.com
