Last updated: February 22, 2026
What is NDC 83324-0160?
NDC 83324-0160 corresponds to Trelegy Ellipta, an FDA-approved inhalation triple therapy for chronic obstructive pulmonary disease (COPD). It combines fluticasone furoate, umeclidinium, and vilanterol. Its approval status and indications define its market scope and pricing.
Market Landscape
Indication and Patient Population
- COPD affects approximately 16 million adults in the US (CDC, 2022).
- Trelegy Ellipta targets patients requiring triple inhaled therapy, representing approximately 30-40% of COPD patients on maintenance medication (GOLD guidelines, 2023).
Competitor Profile
| Product |
Composition |
Market Share (2022) |
Notes |
| Trelegy Ellipta |
Fluticasone, umeclidinium, vilanterol |
45% |
First-in-class triple therapy in inhalers |
| Breo Ellipta |
Fluticasone, vilanterol |
25% |
Market leader in dual inhalers |
| Anoro Ellipta |
Umeclidinium, vilanterol |
12% |
Competition in COPD segment |
| Spiriva |
Tiotropium |
15% |
Long-standing mono-bronchodilator |
Regulatory and Market Trends
- The increasing adoption of triple inhaled therapies correlates with COPD severity.
- US prescription volume for Trelegy Ellipta grew at a CAGR of 7% from 2019-2022.
- The global COPD inhaler market is projected to reach $9.6 billion by 2027, growing at 5.4% CAGR (Fortune Business Insights, 2023).
Patent and Exclusivity Status
- Patent protections for Trelegy Ellipta extend until 2031-2033, with a follow-on biosimilar or generic entry potential from 2029 onward.
- Patent challenges could influence pricing and market share dynamics in the late 2020s.
Pricing Overview
Current Price Point
- Average wholesale price (AWP) for Trelegy Ellipta: $517 per inhaler (per device, based on Red Book 2023).
- Typical prescriptions consist of 30 inhalers, translating to approximately $15,510 per patient annually.
- Commercial insurers often negotiate discounts, reducing patient out-of-pocket costs.
Price Comparisons
| Product |
Average Wholesale Price (AWP) |
Price per Dose |
Dosing Frequency |
Annual Cost (per 30 inhalers) |
| Trelegy Ellipta |
$517 |
~$17.23 |
Once daily |
~$15,510 |
| Breo Ellipta |
$450 |
~$15 |
Once daily |
~$13,500 |
| Spiriva HandiHaler |
$385 |
~$12.83 |
Once daily |
~$11,550 |
Price Trends and Projections
- Prices have remained relatively stable since 2021, with slight reductions due to formulary negotiations.
- Marginal price decreases of 1-2% annually are possible with increased competition.
- Patent expiration and generic entry could drive prices down by 10-20% over the next 3-5 years.
Market Drivers and Constraints
Drivers
- Rising COPD prevalence.
- A shift toward triple therapy for moderate to severe COPD.
- Increasing adoption in managed care due to clinical efficacy.
Constraints
- Strict prescription guidelines.
- High drug costs leading to potential formulary restrictions.
- Entry of generics or biosimilars post-patent expiry.
Price Projection Summary (2023-2028)
| Year |
Estimated Price per Inhaler |
Estimated Annual Cost (30 inhalers) |
Rationale |
| 2023 |
$517 |
$15,510 |
Current pricing, stable market dynamics |
| 2024 |
$510 |
$15,300 |
Slight discounts from negotiations, competition |
| 2025 |
$503 |
$15,090 |
Continued market stabilization |
| 2026 |
$490 |
$14,700 |
Potential price reductions from biosimilar entry |
| 2027 |
$470 |
$14,100 |
Increased generic competition, patent challenges |
Key Takeaways
- The market for Trelegy Ellipta is sizable, with stable growth in prescription volume.
- Current average wholesale prices hover around $517 per inhaler, with annual costs approaching $15,510 per patient.
- Price trajectories are expected to decline modestly over the next five years due to patent expiry and increased competition.
- Significant market drivers include COPD prevalence and guideline-driven treatment patterns, while constraints include regulatory and formulary barriers.
- Generics or biosimilar entrants after 2029 could further reduce prices.
FAQs
1. What are the key competitors to NDC 83324-0160?
Breon Ellipta, Spiriva, and Anoro Ellipta.
2. How does patent expiration impact pricing?
Patent expiry around 2031-2033 may lead to generics or biosimilars, reducing prices by 10-20%.
3. What is the typical annual cost per patient?
Approximately $15,510 for a 30-inhaler prescription at current prices.
4. Are there significant regional pricing differences?
Yes. Negotiated discounts vary by payer and region, often resulting in lower out-of-pocket expenses.
5. What is the future market growth outlook?
The global COPD inhaler market is projected to grow at 5.4% CAGR through 2027, supporting continued demand for Trelegy Ellipta.
References
[1] Centers for Disease Control and Prevention. (2022). COPD prevalence statistics.
[2] Global Initiative for Chronic Obstructive Lung Disease (GOLD). (2023). Global strategy for COPD management.
[3] Fortune Business Insights. (2023). COPD inhaler market report.
[4] Red Book. (2023). Drug pricing and wholesale acquisition costs.
