Last updated: February 15, 2026
What is the drug associated with NDC 31722-0565?
NDC 31722-0565 corresponds to Vokeo (albuterol sulfate inhalation aerosol), approved by the FDA in August 2022. It is indicated for the treatment of bronchospasm in patients 4 years and older, typically as a rescue inhaler for asthma and COPD.
What is the current market landscape?
Market size:
Global asthma market was valued at approximately $13.2 billion in 2022, with inhaled bronchodilators representing over 60% of this figure ([1]). COPD market valued around $45 billion globally in 2021.
Key competitors:
Major products include:
- ProAir HFA (albuterol sulfate): Approximate US sales $630 million in 2022 ([2]).
- Ventolin HFA: Estimated US sales $550 million in 2022 ([2]).
- Proventil HFA: Similar in market share.
Market drivers:
Increase in asthma and COPD prevalence, aging population, and demand for acute rescue inhalers.
Market challenges:
Price sensitivity, inhaler device preferences, generic competition, and regulatory hurdles.
How is the market positioning of Vokeo?
Vokeo enters a mature market dominated by established brand names. As an inhaler, it competes primarily on:
- Efficacy and safety profile: Comparable to existing bronchodilators.
- Pricing and reimbursement: Influences prescribing behavior due to high cost or formulary decisions.
- Delivery device: Newer inhaler designs could offer ease of use or improved delivery.
Vokeo’s unique positioning hinges on being a new formulation with a potentially differentiated device or delivery mechanism.
What are the price projections?
Pricing assumptions:
Initial wholesale acquisition cost (WAC) for Vokeo is estimated at $300 per inhaler (based on comparable inhalers' price points), with a typical prescribing volume of 1-2 inhalers per month per patient.
Market penetration assumptions:
- Year 1: 0.5% of the US inhaled bronchodilator market (~3 million patients) = approximately 15,000 patients.
- Year 2: 1.2% after increased adoption.
Revenue calculation (Year 1):
| Parameter |
Estimate |
Notes |
| Inhalers sold |
180,000 |
15,000 patients x 12 inhalers/year |
| Price per inhaler |
$300 |
Wholesale price |
| Gross revenue |
$54 million |
180,000 inhalers x $300 |
Year 2 projection:
Assuming sales increase by 30% due to higher market acceptance, revenue reaches approximately $70 million.
Pricing pressure:
Generic competition could reduce prices by 20-30% within 2-3 years of launch as patent and exclusivity periods decline.
What does future growth look like?
Drivers:
- Expansion into international markets.
- Development of fixed-dose combination inhalers.
- Adoption in pediatric and elderly populations.
Risks:
- Patent challenges.
- Regulatory delays or additional approval requirements.
- Incremental adoption rate due to clinician preference for existing products.
Long-term projections:
If market share gains reach 3-5% within five years, revenue could approach $150 million annually in the US alone, excluding international sales.
Summary of key factors influencing market and price projections:
| Factor |
Impact |
Notes |
| Competition |
High |
Dominated by established products |
| Pricing |
Moderate |
Initial premium pricing, potential discounts with generics |
| Prescribing patterns |
Variable |
Influenced by physician preferences and insurance formulary decisions |
| Regulatory landscape |
Critical |
Approval of combination products may expand market share |
Key Takeaways
- NDC 31722-0565 (Vokeo) enters a mature inhaled bronchodilator market with high sales volume potential but faces stiff competition.
- Initial US revenue projections estimate sales near $54 million in Year 1, with potential growth to $150 million over five years.
- Price points will likely decline as generic options become available, pressuring margins.
- Long-term growth depends on market acceptance, geographic expansion, and pipeline development of combination therapies.
- Success requires differentiation through device innovation and cost-effective pricing strategies.
FAQs
1. How does Vokeo differ from existing albuterol inhalers?
Vokeo offers a new formulation and potentially improved inhaler device, but clinical efficacy is comparable to existing products.
2. When will Vokeo likely face generic competition?
Typically within 8-10 years post-approval, depending on patent protections and legal challenges.
3. What are key regulatory hurdles for inhaled bronchodilators?
Demonstrating consistent delivery, safety, and device reliability are critical; approvals for combination products can extend timeframes.
4. Can Vokeo leverage existing asthma/COPD sales channels?
Yes, leveraging established distribution networks accelerates market penetration.
5. How sensitive are sales to price reductions?
A 20% price cut could decrease revenue by similar proportions; high-volume sales mitigate some margin loss.
References
- IQVIA, "Global Asthma Market Report," 2022.
- Symphony Health, "US Inhaled Bronchodilator Sales Data," 2022.
