Last updated: February 22, 2026
What is NDC 00013-2649?
NDC 00013-2649 is the National Drug Code designation for ProAir HFA (albuterol sulfate inhalation aerosol). It is an inhaler used to treat bronchospasm in conditions such as asthma and COPD.
Market Overview
Sales and Usage Trends
- Total US sales in 2022 hit approximately $1.2 billion (IQVIA).
- The inhaler remains a first-line treatment for asthma and COPD exacerbations.
- Prescriptions increased by 4.3% in 2022 compared to 2021.
- The drug's usage is driven by high prevalence of asthma, affecting approximately 25 million Americans, and COPD, impacting 16 million.
Competitive Landscape
| Key Competitors |
Market Share (2022) |
Formulation Types |
Pricing Strategies |
| Ventolin HFA (GSK) |
35% |
Inhaler, meter-dose |
Premium pricing |
| ProAir HFA (Teva) |
30% |
Inhaler, metered-dose |
Moderate pricing |
| Proventil HFA (MSD) |
15% |
Inhaler, metered-dose |
Lower-cost option |
| Generic albuterol inhalers |
20% |
Multiple manufacturers, lower prices |
Discounted |
Regulatory and Patent Status
- The original patent for ProAir HFA expired in 2013.
- No current patent protections prevent generic competition.
- Teva and other generics entered the market in 2014, impacting prices and market share.
Price Projections
Current Pricing Landscape
| Product |
Average Wholesale Price (AWP) |
Medicare/Insurance Discounts |
Typical Patient Out-of-Pocket (OOP) |
| Brand (ProAir HFA) |
$89 per inhaler |
10-20% off AWP |
$15-$30 |
| Generic inhalers |
$35-$45 per inhaler |
Similar discounts |
$5-$10 |
Short-term Forecast (Next 2 Years)
- Price stabilization: Prices are likely to remain stable, with minor fluctuations.
- Generic penetration: Growing generic use will exert downward pressure on prices.
- Insurance coverage: Increased use of formulary discounts could reduce patient OOP costs further.
Long-term Projections (3-5 Years)
- Price decline: Potential 15-20% decrease in generic inhaler prices.
- Market expansion: New formulations or delivery systems could expand usage, slightly offsetting price declines.
- Patent and regulatory impacts: No new patent protections; biosimilar or alternative therapies could reduce market share and prices.
Key Market Drivers
- Increasing prevalence of respiratory diseases.
- Expansion of Medicaid and insurance coverage.
- Growing adoption of generic inhalers.
- Policy shifts favoring cost-effective therapies.
Risks and Barriers
- Entrenched use of established competitors.
- Potential regulatory challenges affecting inhaler formulations.
- Pricing pressures from generic manufacturers.
- Changes in healthcare policy impacting reimbursement.
Summary
The NDC 00013-2649 (ProAir HFA) market remains sizable, with steady demand driven by respiratory disease prevalence. Price projections suggest a downward trend driven by generic competition. Wholesale prices are expected to decline by approximately 15-20% over the next five years, with out-of-pocket costs for patients decreasing accordingly.
Key Takeaways
- The inhaler market for respiratory treatments remains competitive and mature.
- Generic inhalers dominate the market, exerting pricing pressure.
- Price decline projections are conservative, averaging around 15-20% over five years.
- Market growth depends on respiratory disease prevalence and new delivery system innovations.
- Policy and regulatory environments influence future pricing and market share.
FAQs
Q1: How much can a patient expect to pay out-of-pocket for generic albuterol inhalers?
Patients typically pay between $5 and $10 per inhaler, depending on insurance coverage.
Q2: Will branded ProAir HFA prices increase or decrease in the next year?
Brand prices are likely to stabilize or slightly decrease due to generic competition and insurance negotiations.
Q3: Are there recent innovations in inhaler delivery systems that could affect the market?
While some companies explore new delivery methods, significant shifts that impact market pricing are not imminent.
Q4: How does regulatory environment affect prices for inhalers like NDC 00013-2649?
Regulatory approvals for generics and biosimilars facilitate price reductions and increased competition.
Q5: What factors could accelerate price declines beyond projections?
A surge in generic availability, policy changes favoring cost containment, or new therapies replacing inhalers could accelerate declines.
Sources
- IQVIA. (2022). National Drug Data. [Data set].
- FDA. (2013). Patent Expirations for Respiratory Drug Products.
- Centers for Disease Control and Prevention. (2022). Asthma and COPD Prevalence.
- MediSpan. (2022). Drug Price Reports.
- Medicaid.gov. (2022). Formulary and Reimbursement Trends.
