Last updated: March 2, 2026
What is the drug associated with NDC 68462-0584?
NDC 68462-0584 corresponds to Levalbuterol Sulfate Inhalation Solution, 0.31 mg/3 mL. This medication is used as a bronchodilator to relieve bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease (COPD).
Market size and current demand overview
-
The global asthma and COPD treatment market was valued at $51 billion in 2022 and expected to grow at a CAGR of 4.5% through 2030 [1].
-
Levalbuterol, as a short-acting beta-2 agonist, accounts for approximately 20-25% of inhaled bronchodilator sales in the U.S. [2].
-
The inhalation solution form, used mainly in hospital and outpatient settings, faces competition from dry powder inhalers (DPI) and metered-dose inhalers (MDI).
Pricing benchmarks
-
Currently, the average selling price (ASP) for levalbuterol inhalation solution (concentrations 0.31 mg/3 mL) is approximately $40–$60 per 30 mL vial in the U.S. wholesale markets [3].
-
The drug is supplied primarily by generics and a few brand manufacturers, with a typical list price around $50 per vial.
-
Compared to brand name formulations such as Xopenex (brand), which retails for around $80 per vial [4].
Competitive landscape
-
Major competitors include Teva Pharmaceuticals (manufacturer of generic levalbuterol products), Sun Pharmaceutical, and some institutional/specialty suppliers.
-
Compliance with therapy remains an issue; inhalation therapies often face adherence challenges compared to oral treatments.
-
No recent patent exclusivity acts as of 2023, with the last patent expiring around 2014, leading to a competitive generics market.
Price projection analysis
Short-term (1–2 years):
Medium-term (3–5 years):
-
Prices may decline by 10–15% as new manufacturers enter or increase production.
-
Technological shifts toward inhaler devices with easier delivery could marginally impact conventional inhalation solutions’ demand.
Long-term (beyond 5 years):
-
Potential for price stabilization or slight increase if demand shifts toward hospital settings or customized formulations.
-
The emergence of biosimilars or alternative delivery systems could influence future pricing structures.
Factors influencing future pricing
-
Patent and exclusivity status: As patent protection has expired, market entry by generics remains unrestricted.
-
Regulatory changes: Any policy to control drug prices or encourage biosimilar development could impact ASPs.
-
Technological advances: Transition to inhalers with digital tracking or alternative drug delivery methods may affect demand for traditional inhalation solutions.
-
Healthcare provider and payer reimbursement policies: Shifts toward value-based pricing models could influence market prices.
Summary of key data points
| Aspect |
Details |
| Current ASP |
$40–$60 per 30 mL vial |
| Market size |
20–25% of inhaled bronchodilators in US |
| Competition |
Generics dominate; brand (Xopenex) around $80 |
| Patent status |
Expired as of 2014; unrestricted generic entry |
| Price trend forecast |
Slight decline in short-term; stabilization later |
Key Takeaways
- NDC 68462-0584 corresponds to a widely used generic inhalation solution with stable market demand.
- Pricing remains competitive due to the proliferation of generics, with prices around $50 per vial.
- Market growth is constrained by multiple delivery options and adherence issues.
- Price declines are likely short-term, but long-term stabilization is possible in competitive markets.
- Future innovations or policy changes could alter scope and pricing strategies.
FAQs
1. What are the main competitors to this drug?
Generic inhalation solutions from Teva and Sun Pharmaceutical dominate the market, with brand alternatives like Xopenex offering higher prices.
2. Is there patent protection remaining for this drug?
No; patent protection expired in 2014, allowing unrestricted generic competition.
3. How does pricing compare in global markets?
Prices vary globally due to local regulations, insurance schemes, and market competition, typically lower outside the U.S.
4. What are the major factors influencing future prices?
Patent/nearexpiry status, emerging delivery technologies, market demand shifts, and policy/regulatory changes.
5. Could new formulations impact demand?
Yes; inhalers with digital features or alternative delivery systems could reduce demand for traditional inhalation solutions.
References
[1] MarketResearch.com. (2022). Global Asthma and COPD Market Report.
[2] IMS Health. (2022). Inhaled Bronchodilator Sales Data.
[3] GoodRx. (2023). Inhalation Medication Price List.
[4] Drugs.com. (2023). Xopenex Pricing and Availability.
Note: All data are estimates based on publicly available sources and market dynamics as of early 2023.
