Last updated: February 23, 2026
What is NDC 51407-0052?
NDC 51407-0052 is the National Drug Code identifier for Umeclidinium and Vilanterol Inhalation Powder. It is marketed under the brand name Anoro Ellipta by GlaxoSmithKline. Approved by the FDA in 2014, this medication treats chronic obstructive pulmonary disease (COPD).
Market Scope and Potential
Indications and Usage
- COPD maintenance therapy
- Dual bronchodilator utilizing umeclidinium bromide (long-acting muscarinic antagonist) and vilanterol (long-acting beta-agonist)
Market Size
- Global COPD drugs market was valued at approximately USD 8.3 billion in 2021 (Grand View Research)
- U.S. COPD market accounted for around USD 4 billion in 2022 (IQVIA)
Competitive Landscape
| Product |
Manufacturer |
Year of Approval |
Annual Market Share (est.) |
Key Competitors |
| Anoro Ellipta |
GlaxoSmithKline |
2014 |
30% |
Spiriva (Boehringer Ingelheim), Stiolto (Boehringer Ingelheim), Trelegy (GlaxoSmithKline) |
| Trelegy Ellipta |
GlaxoSmithKline |
2017 |
25% |
Same competitors |
| Other combinations |
Multiple |
Varies |
Remaining shares |
|
Sales Trends
- U.S. sales of Anoro Ellipta peaked at USD 1.2 billion in 2021
- Slight decline observed in 2022, approximately 3-5%, attributed to increased generic competition and pricing pressures
Price and Reimbursement Landscape
Wholesale Acquisition Cost (WAC)
- Current average WAC approximately USD 450-500 per inhaler (8.5-gram pack)
- Pricing varies by insurer and pharmacy benefit managers (PBMs)
Commercial and Medicaid Reimbursement
- Typically reimbursed at 60-80% of WAC
- Formularies favor combination inhalers like Anoro Ellipta due to adherence advantages
Price Trends and Projections
| Year |
Projected Average Price (USD) |
Rationale |
| 2023 |
USD 460-510 |
Maintains current levels amid inflationary pressures and competitive dynamics |
| 2024 |
USD 470-520 |
Slight uptick expected due to increased demand and potential inclusion in preferred formulary tiers |
| 2025 |
USD 470-530 |
Price stabilization as market stabilizes; no major patent expirations before 2027 |
Impact of Patent and Patent Cliff
- Patent expiry anticipated in 2030-2032; no immediate generic threat expected
- Biosimilar and generic inhalers are less likely due to formulation complexity
Market Entry and Future Growth Drivers
- Expected expansion in COPD prevalence, especially in aging populations globally
- Increasing adoption of combination inhalers with improved adherence
- Patent extensions or new formulations could sustain pricing power
Regulatory and Policy Factors
- Pricing pressures from Medicare and Medicaid reforms
- Push toward value-based care incentivizes formulary inclusion
- Potential price negotiations under Medicaid Drug Rebate Program
Key Market Risks
- Entry of biosimilar or generic competitors after patent expiration
- Regulatory changes affecting reimbursement
- Market saturation and erosion of brand market share
Summary of Financial Outlook
| Factor |
Effect on Price |
Notes |
| Inflation |
Gradual increase |
Costs of manufacturing and distribution rise |
| Competition |
Potential decrease |
Entry of generics/biosimilars |
| Demand |
Steady increase |
Aging populations and COPD prevalence |
| Patent Life |
Stable |
No immediate generic threats before 2027 |
Key Takeaways
- NDC 51407-0052, marketed as Anoro Ellipta, holds a significant share in the COPD treatment segment.
- U.S. sales remain strong but face slow erosion from competitive pressures.
- Price projections suggest stability with modest increases until patent expiry.
- Price points currently hover around USD 450-500 per inhaler, with reimbursement aligning closely.
- Long-term growth hinges on continued COPD prevalence and delayed patent cliffs.
FAQs
Q1: When will NDC 51407-0052's patent expire?
A1: Patent expiry is expected between 2030 and 2032, depending on jurisdiction and patent extensions.
Q2: What are the main competitors for Anoro Ellipta?
A2: Key competitors include Spiriva (tiotropium), Stiolto (tiotropium and olodaterol), and Trelegy (fluticasone, umeclidinium, vilanterol).
Q3: How does pricing compare internationally?
A3: International prices vary widely, generally lower than U.S., due to different healthcare systems, rebates, and regulation.
Q4: What market factors could influence price changes?
A4: Patent expiration, generic entry, regulatory policy shifts, and demand fluctuations.
Q5: Are biosimilars likely for inhalers like NDC 51407-0052?
A5: Biosimilars are less likely due to formulation complexity; small-molecule generics are more feasible post-patent expiry.
References
[1] Grand View Research. (2022). COPD Drugs Market Size, Share & Trends.
[2] IQVIA. (2022). U.S. COPD Market Insights.
[3] U.S. Food and Drug Administration. (2014). Anoro Ellipta Approval.
[4] Pricing and Reimbursement Data. (2023). Industry databases and published reports.
