Last updated: February 27, 2026
What is NDC 62756-0512?
NDC 62756-0512 refers to Incruse Ellipta (umeclidinium bromide), a bronchodilator approved for maintenance treatment of COPD. It is marketed by GlaxoSmithKline (GSK). Approved by the FDA in 2017, Incruse Ellipta is administered via inhalation and is part of the long-acting muscarinic antagonist (LAMA) class.
Market Position and Competition
Market Overview
The COPD treatment market experienced steady growth from approximately $13 billion in 2022, driven by aging populations and increased prevalence rates ([1]). Incruse Ellipta holds a niche centered on LAMA monotherapy, competing primarily with other inhaled bronchodilators.
Key Competitors
| Drug Name |
Class |
Approval Year |
Annual Sales (2022) |
Pricing (Per Inhaler) |
| Tiotropium (Spiriva) |
LAMA |
2004 |
~$3.6 billion |
$300 - $350 per inhaler |
| Glycopyrrolate (Seebri) |
LAMA |
2015 |
$500 million |
$350 - $400 per inhaler |
| Umeclidinium (Incruse) |
LAMA |
2017 |
~$800 million |
$350 - $400 per inhaler |
Adoption Trends
Incruse Ellipta benefits from a favorable inhaler device, ease of use, and GSK's established distribution channels. It appeals to patients requiring maintenance LAMA therapy. Market penetration remains moderate, with around 4-5% of the COPD treatment market share as of 2022.
Regulatory Outlook
There are currently no imminent patent expirations for Incruse Ellipta, but generic competition could emerge by 2030 if patent challenges succeed or patents expire.
Price Projections
Current Pricing Landscape
Inhaler pricing ranges from $350 to $400 per unit, with payers and pharmacies negotiating discounts, rebates, and formulary positioning.
Estimated Future Pricing Trends
- Short term (next 2-3 years): Prices are expected to remain stable with minor discounts due to insurance negotiations. Price erosion is unlikely unless new entrants or generics appear.
- Medium term (3-5 years): Marginal decreases of 5-10% could occur if payer pressure increases or if new generic entrants reduce market prices.
- Long term (5+ years): Significant price declines possible upon patent expiry or if biosimilar inhalers are approved, potentially reducing prices by up to 30-50%.
Volume and Revenue Projections
Assuming a steady market share and stable pricing, potential revenues for GSK in the COPD LAMA segment could grow marginally:
| Year |
Estimated Units Sold (millions) |
Average Price Per Inhaler |
Revenue (USD millions) |
| 2023 |
20 |
$375 |
$7,500 |
| 2025 |
22 |
$370 |
$8,140 |
| 2030 |
25 |
$330 |
$8,250 |
Growth assumptions rely on increased COPD prevalence and stable uptake, with minor price reductions over time.
Regulatory and Patent Landscape
Patent Protection
GSK's patent for Incruse Ellipta extends into the mid-2020s, with potential extensions. Patent challenges could narrow protections, enabling generic competition by 2030, depending on legal outcomes.
Potential for Biosimilars and Generics
No biosimilars or generics are currently approved. Approval pathways via abbreviated new drug applications (ANDAs) could lead to reduced market prices in the next decade if legal obstacles are cleared.
Key Factors Affecting Market and Prices
- Market penetration: Prescriber and payer acceptance influence revenue.
- Patent litigation: Patent challenges can accelerate generic entry.
- Regulatory approvals: New formulations or combination therapies could impact pricing.
- Pricing strategies: Rebates, discounts, and formulary placements influence net prices.
Key Takeaways
- NDC 62756-0512 (Incruse Ellipta) is a GSK monotherapy inhaler approved for COPD maintenance.
- The drug's market share remains moderate with competition from Tiotropium and Glycopyrrolate.
- Pricing per inhaler maintains around $350 to $400, with minor downward pressure forecasted.
- Patent protections extend into the mid-2020s; generic competition potentially emerges around 2030.
- Revenue projections assume steady volume growth with slight price erosion, maintaining annual sales near $8 billion in the mid-term.
FAQs
1. What factors could lead to significant price reductions for Incruse Ellipta?
Patent expiration, patent invalidation, or approval of generic competitors.
2. How does Incruse compare in efficacy to Tiotropium?
Clinical trials show comparable efficacy; choice depends on device preferences and formulary considerations.
3. Are there upcoming regulatory changes affecting COPD drugs?
No major imminent changes; however, new inhaler device regulations and generic pathways could influence pricing.
4. What is the likelihood of biosimilars impacting inhaler prices?
Low; inhalers are small molecule drugs without biosimilar pathways, but generics may emerge.
5. What strategies could GSK pursue to extend product lifecycle?
Developing combination products, expanding indications, or innovating delivery devices.
Citations
[1] IQVIA. (2022). The Impact of COPD Treatments on Market Share and Pricing.
