Last updated: March 8, 2026
What is the Drug Associated with NDC 65145-0169?
The National Drug Code (NDC) 65145-0169 refers to Ellipta, fluticasone furoate and vilanterol inhalation powder, marketed by GSK (GlaxoSmithKline). It is indicated for the long-term maintenance treatment of airflow obstruction in COPD and asthma.
Market Size and Demand
Current Market Overview
The COPD and asthma treatment market involves significant sales, driven by prevalence, treatment guidelines, and patent status.
- Global COPD Market: Estimated at USD 15 billion in 2022, expected to grow 4-5% annually through 2030.
- Global Asthma Market: Valued at USD 20 billion in 2022, with a CAGR of 4-5%.
Patient Population
- U.S. COPD prevalence: 15-20 million adults.
- U.S. asthma prevalence: 25 million Americans.
Competitive Landscape
Main competitors include other inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combinations:
- Symbicort (budesonide/formoterol)
- Advair (fluticasone propionate/salmeterol)
- Breo Ellipta (fluticasone furoate/vilanterol)
Market Penetration
GSK holds significant market share in inhaler therapeutics, with Ellipta formulations covering 40-50% of supplies in COPD and asthma segments.
Regulatory and Patent Environment
Patent Timeline
- Original patents expiring in 2023-2024.
- GSK has filed for extensions and new formulations to delay biosimilar entry.
Regulatory Status
- Approved in the U.S. in 2014.
- Approved in Europe in 2014.
- Post-approval, the therapy maintains exclusivity until patents expire unless challenged.
Price Projections
Current Pricing Data
- Wholesale Acquisition Cost (WAC): Approximately USD 515 per inhaler (30-day supply).
- Average Selling Price (ASP): USD 540–560 per inhaler, depending on region and distributor contracts.
- Patient Copays: Vary based on insurance; roughly USD 10–50 per month.
Short-term Pricing Trends
- Slight discounts for multi-inhaler-pack purchases.
- Price stagnation observed over the past 2 years.
Long-term Price Outlook
- Post-patent expiry (2023–2024):
- Entry of biosimilars expected.
- Prices could decrease by 15–30%, depending on market competition.
- Price erosion will likely be limited if GSK maintains patent protections and launches new formulations.
Estimations for 2024–2028
| Year |
Estimated Price per Inhaler |
Notes |
| 2024 |
USD 450–500 |
Biosimilar competition begins; prices decline |
| 2025 |
USD 420–470 |
Further price stabilization with generic entries |
| 2026 |
USD 400–440 |
Market saturation; price stabilizes |
| 2027 |
USD 380–420 |
Potential reformulation launches |
| 2028 |
USD 370–410 |
Mature market, steady prices |
Market Risks & Opportunities
Risks
- Increased biosimilar competition post-2023.
- Pricing pressure from generic entrants.
- Shifts in treatment guidelines favoring new therapies.
- Supply chain disruptions affecting pricing.
Opportunities
- Expansion into emerging markets with lower price points.
- Adoption of digital health solutions to improve adherence.
- Combination therapies improving market share.
Key Takeaways
- NDC 65145-0169 pertains to GSK's Ellipta inhaler, with a dominant market share in inhaled COPD/asthma therapies.
- The current wholesale price is around USD 515 per inhaler, with potential for reduction following patent expiry.
- Biosimilar competition expected to begin in 2023-2024, reducing prices by 15–30%.
- The market size remains robust, driven by large COPD and asthma populations.
- Future pricing will depend on market competition, patent status, and regional regulations.
Frequently Asked Questions
-
What factors influence the price of inhaled COPD medications?
Patent status, market competition, manufacturing costs, formulary negotiations, and regional healthcare policies.
-
When will biosimilars for Ellipta likely enter the market?
Patent expiry is projected for 2023-2024, with biosimilar approvals possibly following in the subsequent 1-2 years.
-
How does regional regulatory environment affect pricing?
Countries with government price controls or tenders may have lower prices; regions with less regulation may see higher prices.
-
Are there recent indications of price stabilization or reduction?
Yes, prices have plateaued recently, with potential declines post-patent expiration.
-
What new developments could disrupt current market dynamics?
New inhaler technologies, oral therapies, or biologics with superior efficacy may impact demand.
References
- IMS Health (2022). Global Pharmaceutical Market Report.
- GSK (2022). Ellipta product information and regulatory filings.
- FDA (2022). Approved drugs and patent data.
- IQVIA (2022). U.S. prescription market analysis.
- European Medicines Agency (2022). Marketing authorization data.
(Note: All data and projections are derived from publicly available market and regulatory reports as of early 2023.)
