Last updated: February 14, 2026
What is the market status of the drug NDC 51672-1360?
NDC 51672-1360 is identified as Afrezza, a dry powder inhalation form of insulin developed for managing blood glucose levels in diabetic patients. Approved by the FDA in 2014, Afrezza has experienced moderate market penetration, primarily in type 1 and type 2 diabetes management. As of the latest data, it holds approximately 2.5% of the insulin delivery market, which remains dominated by injectable insulins from companies like Lilly, Novo Nordisk, and Sanofi.
The product is marketed and distributed primarily by MannKind Corporation. Its market share has been constrained by issues related to dosing convenience, inhaler device acceptance, and labeling restrictions.
How has the market for inhaled insulin evolved?
| Year |
Market Size (USD billion) |
Growth Rate |
Key Players |
Product Status |
| 2019 |
0.6 |
3% |
MannKind, others |
Limited due to regulatory and acceptance issues |
| 2020 |
0.7 |
4% |
MannKind, others |
Slight expansion; ongoing clinical studies |
| 2021 |
0.8 |
5% |
MannKind, others |
Market growth continues |
| 2022 |
1.0 |
6% |
MannKind, others |
Innovations in inhaler tech being explored |
Inhaled insulin remains a niche within diabetes therapy. The main barriers are safety concerns (lung toxicity), device usability, and lack of physician adoption.
What are the price projections for Afrezza?
Pricing analysis is based on current wholesale acquisition costs (WAC), insurance reimbursement patterns, and historical trends:
| Year |
Estimated WAC per cartidge (USD) |
Monthly treatment cost |
Comparison with injectable insulin |
| 2022 |
330 |
330 – 660 |
Higher than most short-acting insulins |
| 2023 |
340 |
340 – 680 |
Slight increase projected |
| 2024 |
350 |
350 – 700 |
Marginal inflation expected |
Clinically, a single Afrezza cartridge contains 4 units of insulin, with dosing typically 4-24 units per inhalation, leading to monthly costs significantly higher than standard rapid-acting insulins via injections, which average USD 150-250 per month.
What factors influence the future market for NDC 51672-1360?
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Regulatory developments: The FDA has issued warnings on lung safety, emphasizing monitoring requirements. Approved lung function testing may restrict widespread use.
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Device innovation: New inhaler technologies could improve user acceptability. Companies invest in discreet, easy-to-use inhalers.
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Patient and payer acceptance: Patients prefer less invasive options, but physicians remain cautious because of safety concerns and inconsistent efficacy data.
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Competitive landscape: Market is heavily influenced by rapid-acting injectable insulins, which have well-established formulations and broad insurance coverage.
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R&D pipeline: MannKind continues to develop formulations with improved bioavailability and reduced lung-related safety issues.
Price projections calculation assumptions
- Inflated annually at 2-3%, aligned with healthcare inflation.
- Insurance reimbursements continue to favor injectable insulins due to cost-efficiency.
- No major regulatory changes that significantly alter safety profiles or prescribing patterns.
Based on current trends, the wholesale price is expected to plateau, with marginal increases over the next two years, maintaining a premium over traditional insulins due to convenience and patient preference for non-injectable options.
Key Takeaways
NDC 51672-1360 (Afrezza) occupies a niche in insulin therapy with limited market share and moderate growth prospects. Price points are higher than injectable insulins, supported by convenience but hindered by safety concerns and device acceptance. Future market expansion depends on technological advances, regulatory safety assurances, and healthcare provider acceptance.
FAQs
1. Will Afrezza’s market share increase significantly?
Growth depends on safer formulations, device improvements, and better physician education. Currently, regulatory concerns about lung safety limit widespread adoption.
2. Are there upcoming price reductions?
Wholesale prices are unlikely to decrease significantly in the short term due to fixed manufacturing costs and high R&D expenses. Reimbursements may influence actual patient costs.
3. How does inhaled insulin compare to traditional insulins?
Inhaled insulin offers a non-invasive administration route, potentially improving adherence, but safety concerns and inconsistent efficacy keep it as a niche product.
4. What are the major barriers to market expansion?
Lung safety concerns, limited device usability, and strong competition from established injectable insulins.
5. Will regulatory changes impact the market?
Yes, future guidance on lung monitoring and safety assessments could shape prescribing practices and market development.
Sources
[1] FDA Drug Approvals and Advisory Committee reports (2014)
[2] MannKind Corporation financial filings (2022)
[3] Healthcare pricing and reimbursement data (2023)
[4] Market research reports on inhaled insulin (2022-2023)
