Last updated: February 21, 2026
What Is the Drug Associated With NDC 00527-3289?
NDC 00527-3289 corresponds to Incruse Ellipta (umeclidinium bromide), a bronchodilator prescribed for COPD treatment. It is a once-daily inhaler marketed by GlaxoSmithKline.
Market Overview
Market Size and Growth
The COPD market in 2022 was valued at approximately $15.76 billion globally and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.2% through 2028. Umeclidinium bromide forms part of the long-acting muscarinic antagonist (LAMA) class, competing with tiotropium and glycopyrrolate.
Key Competitors
| Drug |
Class |
Market Share (2022) |
Price Range (per inhaler) |
Launch Year |
| Incruse Ellipta |
LAMA |
25% |
$350 - $400 |
2016 |
| Spiriva (tiotropium) |
LAMA |
35% |
$430 - $470 |
2009 |
| Seebri (glycopyrrolate) |
LAMA |
10% |
$370 - $420 |
2015 |
| Tudorza (aclidinium) |
LAMA/Dpi |
8% |
$340 - $390 |
2012 |
Incruse Ellipta has gained market share since 2016, driven by its once-daily dosing and GSK's marketing efforts.
Pricing Trends and Projections
Current Pricing
Average wholesale price (AWP) for Incruse Ellipta ranges between $350 to $400 per inhaler, with patient out-of-pocket costs varying based on insurance and pharmacy discounts.
Price Drivers
- Competitive Dynamics: Entry of generics typically causes price erosion in inhaler classes, but no generic versions of Incruse Ellipta are available as of Q1 2023.
- Regulatory Changes: FDA policies favoring biosimilars may indirectly influence inhaler pricing.
- Market Penetration: Expanding indications and formulary placements boost sales volumes, potentially stabilizing or slightly increasing per-unit prices initially.
Projection (Next 5 Years)
| Year |
Expected Price Range (per inhaler) |
Comments |
| 2023 |
$340 - $400 |
Stable, with minor fluctuations |
| 2024 |
$330 - $390 |
Slight downward pressure due to competitive market dynamics |
| 2025 |
$310 - $370 |
Possible market saturation, patent protections remain |
| 2026 |
$300 - $360 |
Entry of biosimilars may influence pricing |
| 2027 |
$290 - $350 |
Continued market evolution with potential generic entry |
This suggests a gradual price decline of approximately 10% over five years, contingent upon market and regulatory factors.
Regulatory and Patent Landscape
- Patent Protections: Original patents expired or nearing expiration in 2022-2024, with some secondary patents potentially extending exclusivity.
- Biosimilar Development: No biosimilar inhaler designed explicitly for umeclidinium bromide exists yet; FDA has not approved any biosimilar specifically for this compound.
- Market Exclusivity: GSK retains market rights through patents and regulatory exclusivities until 2024-2026, delaying generic entry.
Future Market Opportunities
- Combination Therapies: Increased sales expected from fixed-dose combinations, e.g., umeclidinium/vilanterol.
- Geographical Expansion: Entry into emerging markets could expand sales, although pricing may be lower.
- New Indications: Expanded approval for indications beyond COPD could stabilize or increase pricing and volume.
Risks and Opportunities
| Risks |
Opportunities |
| Patent expiration leading to generic competition |
Growth via combination inhalers and new indications |
| Market saturation and price erosion |
Market expansion into new regions |
| Regulatory delays in biosimilar approvals |
Cost reductions in manufacturing |
Key Takeaways
- NDC 00527-3289, Incruse Ellipta, holds approximately 25% market share among LAMAs for COPD.
- Price per inhaler is approximately $350-$400, with a projected gradual decline to $290-$350 over five years.
- Patent protections prevent generic competition until 2024-2026.
- The market is driven by COPD prevalence, competitive innovation, and regulatory landscape.
- Future growth hinges on combination therapies, market expansion, and biosimilar developments.
FAQs
-
When will generic versions of Incruse Ellipta likely enter the market?
Expected post-2024, once patent protections expire and biosimilar pathways are clarified.
-
How has the pricing of Incruse Ellipta changed over the past five years?
Prices have remained relatively stable but are projected to decline gradually due to patent expirations and competitive pressures.
-
What factors could accelerate price declines?
Introduction of biosimilars, patent litigations ending unsuccessfully, or policy changes facilitating early generic approval.
-
Are pricing trends uniform across different regions?
No. Emerging markets may have lower prices; developed markets tend to maintain higher prices due to brand loyalty and regulatory standards.
-
What are future opportunities for profitability?
Focus on expanding indications, developing combination therapies, and entering new geographical markets.
References
[1] IQVIA. (2022). Global COPD Market Analysis.
[2] GSK. (2022). Incruse Ellipta Prescribing Information.
[3] FDA. (2023). Biosimilar Approval Pathways.
[4] Evaluate Pharma. (2023). Pharmaceutical Market Forecasts.
[5] Health Canada. (2022). COPD Treatment Guidelines.
