Last updated: February 13, 2026
Product Overview
NDC 00093-0308 is a medication marketed as Symbicort (budesonide/formoterol). It is a combination inhaler used primarily for asthma and chronic obstructive pulmonary disease (COPD). Symbicort combines a corticosteroid (budesonide) and a long-acting beta-agonist (formoterol). It is administered via metered-dose inhaler (MDI).
Market Size and Key Drivers
The global COPD and asthma markets drive demand for Symbicort. The key factors influencing market size include:
- Prevalence: Asthma affects approximately 262 million individuals worldwide as of 2021; COPD afflicts roughly 200 million globally.
- Prescription Volume: U.S. prescriptions for Symbicort reached approximately 5 million units annually, with growth rates averaging 4-6% per year over the past five years.
- Competitive Landscape: Symbicort competes against brands like Advair (fluticasone/salmeterol), Breo Ellipta (fluticasone furoate/vilanterol), and others.
- Regulatory Status: It holds FDA approval for use in multiple countries, with ongoing label expansions for pediatric use and COPD indications.
Market Trends
- Market expansion driven by increased COPD diagnoses due to aging populations.
- Adoption of combination inhalers to improve adherence.
- Transition towards generic formulations; however, recent patent protections limit immediate generic entry.
Pricing Data and Trends
Current Price Range
- U.S. retail price per inhaler: USD 300 to USD 350.
- Average wholesale acquisition cost (WAC): USD 275.
- Patient out-of-pocket costs: USD 30 to USD 70, depending on insurance.
Historical Price Trends
Between 2018 and 2022, prices increased by approximately 3-4% annually, driven by inflation, manufacturing costs, and market exclusivity.
Patent and Patent Expirations
- Patent protections generally extend until 2025–2027.
- Patent litigation delays generic entry; patent litigations are ongoing.
Price Projection Scenarios
- Optimistic scenario (patent extension, high demand): prices stabilize around USD 340– USD 360 over the next 3-5 years.
- Moderate scenario (partial patent challenges or biosimilar development): prices decline 10–15% to USD 260–USD 300.
- Pessimistic scenario (early patent invalidation and aggressive generic market entry): prices drop below USD 200 within 3 years.
Forecast Table (Next 5 Years)
| Year |
Low Scenario |
Moderate Scenario |
High Scenario |
| 2023 |
USD 320 |
USD 330 |
USD 340 |
| 2024 |
USD 300 |
USD 315 |
USD 340 |
| 2025 |
USD 280 |
USD 300 |
USD 350 |
| 2026 |
USD 260 |
USD 285 |
USD 350 |
| 2027 |
USD 250 |
USD 275 |
USD 355 |
Market Entrants and Impact
- Biosimilar competitors are in development but face regulatory and patent hurdles.
- Price erosion is limited until patent expiry or biosimilar approval.
- Contract-based discounts and payer negotiations also influence actual sale prices.
Regulatory and Policy Considerations
- Increased scrutiny on drug pricing by the FDA and CMS.
- Potential policy shifts favoring biosimilars and generics could accelerate price declines.
- Price controls or negotiation caps may impact future pricing strategies.
Summary
Symbicort (NDC 00093-0308) is a high-value inhaler with robust demand in asthma and COPD markets. Prices are currently stable but face downward pressure from patent challenges and biosimilar development. Short-term prices are expected to remain near current levels, with significant declines possible post-patent expiry (2025–2027).
Key Takeaways
- Symbicort remains a leading combination inhaler with high prescription volumes.
- Pricing is influenced by patent protections, market competition, and regulatory policies.
- Prices are projected to decline 10–15% under moderate scenarios, with sharper drops after patent expiration.
- Market growth depends on COPD and asthma prevalence, especially in aging populations.
- Industry trends favor biosimilar entry, which could significantly affect future pricing.
FAQs
1. When do patents on Symbicort expire?
Patents are expected to expire around 2025–2027, depending on jurisdiction and patent litigation outcomes.
2. What are the main competitors to Symbicort?
Advair (fluticasone/salmeterol), Breo Ellipta (fluticasone furoate/vilanterol), and Dulera (mometasone/formoterol).
3. How does price sensitivity vary among patients?
Patients with high deductible plans or without insurance face higher out-of-pocket costs, influencing prescription adherence and volume.
4. What regulatory changes could affect pricing?
Potential CMS negotiations, drug price caps, and approval of biosimilars may pressure prices downward.
5. Will biosimilar versions significantly impact the market?
Yes. Biosimilar entry could reduce prices by 30–50%, depending on market penetration and regulatory approvals.
References
[1] IQVIA National Prescription Data, 2022.
[2] Global Asthma and COPD Market Analysis Reports, 2022.
[3] U.S. Food and Drug Administration, Patent Status, 2023.
[4] MarketWatch, "Symbicort Pricing Trends," 2022.
[5] Centers for Medicare & Medicaid Services, Drug Pricing Data, 2023.
