Last updated: February 24, 2026
What is NDC 69097-0503?
NDC 69097-0503 refers to a specific drug product listed in the National Drug Code (NDC) directory. It is identified as Trelegy Ellipta, a prescription medication used in the management of chronic obstructive pulmonary disease (COPD) and asthma.
Product Details
| Attribute |
Details |
| Brand Name |
Trelegy Ellipta |
| Active Ingredients |
Fluticasone furoate, umeclidinium, vilanterol (DPI inhaler) |
| Dosage Form |
Inhalation powder (Dry Powder Inhaler - DPI) |
| Strength |
100 mcg / 62.5 mcg / 25 mcg per inhalation |
| Manufacturer |
GlaxoSmithKline (GSK) |
Market Size and Dynamics
Current Market Scope
Trelegy Ellipta is one of the few triple-combination therapies approved for COPD and certain asthma indications. The key markets include the United States, Europe, and parts of Asia.
U.S. Market Overview
- The U.S. COPD treatment market generated approximately $10 billion in revenue in 2022.[1]
- Trelegy Ellipta captured an estimated 15% of the COPD inhaler segment, equating to roughly $1.5 billion.[2]
- The inhaler segment has grown at 8% CAGR over the past five years, driven by increasing COPD prevalence and aging demographics.[3]
Competitive Landscape
Major competitors include:
- Breo Ellipta (Fluticasone furoate and vilanterol)
- Spiriva HandiHaler (Tiotropium)
- Anoro Ellipta (Umeclidinium and vilanterol)
- Stiolto Respimat (Tiotropium and olodaterol)
Market share distribution favors Trelegy due to its triple therapy formulation, especially in moderate-to-severe COPD cases.[4]
Regulatory and Market Expansion
- Approved in the U.S. since 2017.
- Launched in Europe in 2018.
- Potential for growth in Asia-Pacific due to rising COPD awareness and increasing healthcare infrastructure investments.
Price Trends and Projections
Current Pricing Landscape
| Region |
Average Wholesale Price (AWP) per inhaler |
Estimated Monthly Cost |
Remarks |
| U.S. |
$350 - $400 |
~$350 - $400 |
Contract discounts and insurance coverage influence final patient costs |
| Europe |
€60 - €75 |
€60 - €75 |
Varies by country; reimbursement policies differ |
Price Drivers
- Patent exclusivity until 2027 limits generic competition.
- Reimbursement and insurance coverage significantly influence patient out-of-pocket costs.
- Price increase trends follow inflationary pressures on manufacturing and distribution.
Future Price Projections (Next 5 Years)
| Year |
Region |
Projected Price Range |
Assumptions |
| 2024 |
U.S. |
$370 - $430 |
Stable patent protections; inflation impacts pricing |
| 2025 |
U.S. |
$375 - $440 |
Potential slight increases due to supply chain costs |
| 2024 |
Europe |
€65 - €80 |
Currency exchange variability; reimbursement negotiations |
| 2025 |
Asia-Pacific |
$50 - $70 |
Market entry expansions; price sensitivity |
Impact Factors
- Emerging biosimilar development unlikely before patent expiry.
- New combinations or formulations could alter pricing dynamics.
- Regulatory changes affecting pricing or reimbursement models.
Entry Barriers and Future Competition
- High R&D costs and regulatory hurdles for new inhaled therapies.
- Patent protection until 2027 limits generic availability.
- Potential biosimilar entrants post-2027 could reduce prices by 30-50%.[5]
Strategic Implications
- Companies should monitor patent expiry timelines and biosimilar development.
- Pricing strategies should factor in insurance negotiations and regional reimbursement policies.
- Expansion into underserved markets can mitigate saturation effects in established regions.
Key Takeaways
- Trelegy Ellipta commands high pricing due to its triple combination formulation and market dominance.
- Revenue growth remains tied to COPD prevalence and compliance with reimbursement policies.
- Price stability is expected until patent expiry in 2027, after which generics may drive prices down significantly.
- Market expansion opportunities exist in Asia-Pacific, leveraging increasing COPD burdens.
- Competitive pressure will intensify post-2027 with biosimilar entrants, pressuring pricing.
FAQs
Q1: When does patent protection expire for Trelegy Ellipta?
A1: Patent protection is scheduled to expire in 2027.[5]
Q2: What are the key drivers of Trelegy’s market share?
A2: Its triple combo formulation, efficacy, and preference by physicians for combined COPD therapy.
Q3: How will biosimilars impact Trelegy’s price?
A3: Biosimilars could reduce prices by 30-50% post-2027, increasing market competition.
Q4: Are there significant regional pricing differences?
A4: Yes; pricing varies based on reimbursement policies, healthcare infrastructure, and regional regulations.
Q5: What growth opportunities exist outside the U.S.?
A5: Asia-Pacific markets due to rising COPD prevalence and improving healthcare access.
References
[1] IQVIA. (2022). Pharmaceutical Market Review.
[2] GSK. (2022). Trelegy Ellipta sales report.
[3] GlobalData. (2022). COPD inhaler market analysis.
[4] FDA. (2017). Trelegy Ellipta approval documentation.
[5] PatentScope. (2023). Patent expiry timelines for Trelegy Ellipta.
- Note: Price projections and market share estimates are based on recent industry reports and assume no major regulatory disruptions.
