Last updated: February 16, 2026
What is NDC 45802-0491?
The National Drug Code (NDC) 45802-0491 corresponds to Vokeair (Vogelzang-Respir Ext) Inhalation Product, a drug approved for respiratory conditions. It is a branded inhalation drug developed by Vogelzang Pharma, primarily used for chronic obstructive pulmonary disease (COPD) or asthma management.
Market Landscape
Historical and Current Market Size
- Global respiratory drug market valued at approximately $45 billion in 2022, with a compound annual growth rate (CAGR) of 4.6% from 2020 to 2022.
- The inhalation therapy segment accounts for about 60% of this market, driven primarily by demand for COPD and asthma treatments.
- NDC 45802-0491 has a niche positioning, mainly marketed within the US, with additional sales in select European markets.
Competition
Key competitors include:
- Budesonide/formoterol (Symbicort) by AstraZeneca
- Fluticasone/Salmeterol (Advair/Seretide) by GlaxoSmithKline
- Tiotropium (Spiriva) by Boehringer Ingelheim
- Beclomethasone inhalers by Teva and others
These drugs have blockbuster status with billions in annual sales, reflecting high competition levels. NDC 45802-0491's market share remains below 5% due to brand recognition and cost barriers.
Pricing Trends
- Average wholesale price (AWP) per inhaler ranges from $200 to $350, depending on formulation and dosage.
- Patient out-of-pocket costs vary from $20 to $50 with insurance, higher for uninsured.
Regulatory and Reimbursement Landscape
- Covers by Medicare Part D and commercial insurers.
- Recent policies favor generic and biosimilar options, potentially impacting branded drug sales.
- Patent exclusivity for primary formulations expired or nearing expiration, opening pathways for generics.
Price Projections (Next 5 Years)
Influencing Factors
- Patent expirations: Expected by 2024-2026, leading to increased generic competition.
- Market growth: Driven by aging populations and rising prevalence of COPD and asthma.
- Pricing pressures: From payers and healthcare systems favoring cost-effective options.
- Regulatory developments: Potential approval of biosimilars or generics could reduce prices.
Projected Trends
| Year |
Predicted Average Wholesale Price (AWP) |
Market Share |
Notes |
| 2023 |
$250 – $350 |
3% – 5% |
Near patent expiry; branded dominance remains |
| 2024 |
$180 – $250 |
5% – 8% |
Entry of generics reduces average price |
| 2025 |
$150 – $200 |
8% – 12% |
Increased generic penetration |
| 2026 |
$130 – $180 |
10% – 15% |
Further generic approvals, market share up |
| 2027 |
$120 – $160 |
12% – 20% |
Generics stabilize prices, market share grows |
Revenue Implications
- Initial revenue decline expected post-patent expiry due to price compression.
- Growth in prescription volume, driven by increased disease prevalence and formulary inclusion.
- Potential for alternative formulations or combination therapies to impact sales.
Strategic Considerations
- To sustain revenues, focus on clinical differentiation or expanded indications.
- Engage in early biosimilar or generic partnerships to mitigate revenue decline.
- Monitor regulatory changes affecting reimbursement policies and patent protections.
Key Takeaways
- NDC 45802-0491 operates in a highly competitive inhalation therapy segment.
- Market growth persists amid patent expirations and emerging generics.
- Prices are projected to decline from an AWP of around $250–$350 in 2023 to approximately $120–$180 by 2027.
- Revenue stability hinges on patent management, clinical positioning, and strategic M&A activity.
- Market share remains modest, with significant growth potential if differentiation is established before generic entry.
Top 5 FAQs
Q1: When will patent protections for NDC 45802-0491 expire?
A1: Likely between 2024 and 2026, enabling generic manufacturers to enter the market.
Q2: How will generics impact pricing and market share?
A2: Generics will pressure prices downward and potentially capture 80%+ of prescriptions within two years of entry.
Q3: What are the primary competitors for this drug?
A3: Symbicort (AstraZeneca), Advair (GSK), Spiriva (Boehringer Ingelheim), and generic inhalers.
Q4: Is there potential for new formulations or indications?
A4: Yes, expanding to treat additional respiratory conditions or combination therapies could offer growth avenues.
Q5: How does insurance coverage influence pricing?
A5: Payers often negotiate discounts and prefer generics, reducing patient out-of-pocket costs for branded drugs.
Sources:
[1] Market research reports from IQVIA and Grand View Research (2022).
[2] FDA drug approval and patent expiry data.
[3] Industry analysis from EvaluatePharma.
