Last updated: February 27, 2026
What Is the Drug with NDC 46122-0707?
The National Drug Code (NDC) 46122-0707 corresponds to Albuterol Sulfate Inhalation Solution, 0.5 mg/amp. It is a short-acting beta-agonist used primarily for relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease (COPD).
Manufactured by Indivior Inc., this inhalation solution is administered via nebulizer.
Market Size and Volume Trends
Current Market Landscape
- The U.S. inhaled respiratory drug market was valued at approximately $4.2 billion in 2022.
- Albuterol inhalers and nebulizer formulations account for roughly 70% of this segment.
- The volume of inhalation solutions like NDC 46122-0707 is declining due to shift from nebulization to metered-dose inhalers (MDIs).
Sales Data
- Estimated annual sales for albuterol nebulizer solutions approximate $600 million in the U.S.
- The volume sold was roughly 12 million units in 2022.
- The average wholesale price (AWP) per unit is approximately $6 to $8.
Competitive Landscape
Primary competitors include:
- Albuterol Sulfate Inhalation Solution (AMP) formulations by various manufacturers.
- Albuterol MDI products such as Ventolin HFA and ProAir HFA.
- Growing presence of generic formulations reduces prices and affects branded product sales.
Regulatory and Patent Status
- The product is a generic version of the branded inhalation solutions.
- Patents on branded products expired by 2012.
- No recent FDA or invalidation issues reported for NDC 46122-0707.
- The drug is labeled for generic interchangeability.
Pricing Trends and Projections
Historical Price Movements
- From 2018 to 2022, prices declined by approximately 25%.
- The average retail price per unit was around $9.50 in 2018 and has since dropped to $6.50–$7.50.
Price Drivers
- Entry of generic competitors.
- Increased use of alternative delivery systems.
- Medicaid and Medicare reimbursement policies favor generics.
Future Price Projections
- Prices are expected to remain stable or decline marginally over the next 2–3 years.
- Flat or slightly decreasing prices forecasted at $6 to $7 per unit.
- The market may experience further compression as biosimilar and alternative therapies gain acceptance.
Cost implications for stakeholders
- Manufacturers should anticipate margin pressure due to fee reductions and competitive bidding.
- Distributors and pharmacies will continue to see downward pressure on prices.
- Payers prioritize cost-effective generic options.
Market Growth and Demand Outlook
- The demand for nebulized albuterol is expected to decline by 2–3% annually owing to increased MDI utilization.
- The aging population with COPD and asthma maintains stable demand.
- The rise of digital health tools and telemedicine may influence prescription patterns.
Key Opportunities and Risks
Opportunities:
- Expansion in hospital and urgent care settings.
- Potential for reformulation into combination therapies.
- Growing adoption in outpatient respiratory management.
Risks:
- Price erosion driven by biosimilar and generic competition.
- Regulatory shifts favoring MDI over nebulizer formulations.
- Potential supply chain disruptions impacting availability.
Conclusions
- NDC 46122-0707 faces a mature, highly competitive market.
- Prices are likely to stay within the current range, with slight downward trends.
- The market will grow modestly, driven by aging populations and respiratory disease prevalence.
- Stakeholders should consider the impact of shifting preferences toward inhalers and generics.
Key Takeaways
- The inhalation solution is a key product in respiratory therapy but is losing market share to MDIs.
- Price projections indicate stability with ongoing downward pressure due to generics.
- Volume and sales are expected to decline gradually as newer delivery systems dominate.
- Stakeholders should monitor regulatory and reimbursement policies affecting this segment.
FAQs
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What are the primary competitors to NDC 46122-0707?
Generic albuterol inhalation solutions and inhalers like Ventolin HFA.
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How are prices expected to change in the next three years?
Prices are projected to remain stable or decline marginally to $6–$7 per unit.
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What factors influence the demand for nebulized albuterol?
Increasing use of inhalers, aging populations, and respiratory disease prevalence.
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Are there patent issues affecting this product?
No recent patent protections or litigations are reported for this generic.
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What market segments are most profitable for this drug?
Hospital and outpatient clinics utilizing nebulizers, with some contribution from retail pharmacies.
References
[1] IQVIA. (2022). U.S. Prescription Drug Market Data.
[2] U.S. Food and Drug Administration. (2022). Drug Approvals and Patents.
[3] MarketsandMarkets. (2023). Respiratory Drugs Market Analysis.
[4] MediSpan. (2022). Drug Price Database.
[5] Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies for Respiratory Drugs.
