Last updated: February 24, 2026
What is NDC 49502-0394?
NDC 49502-0394 is a prescription drug identified by the National Drug Code (NDC). It corresponds to Soleo (beclomethasone dipropionate inhalation aerosol). This inhaler is used for managing persistent asthma in patients aged 12 years and older.
Product Overview
| Attribute |
Details |
| Drug Name |
Soleo (beclomethasone dipropionate inhaler) |
| Dosage |
100 mcg per inhalation |
| Packaging |
120 inhalers per package (typically) |
| Manufacturer |
Cipla Ltd. (as per recent approvals, may vary) |
| Approval Date |
September 14, 2018 |
Market Landscape
Market Size and Trends
- Asthma prevalence: The U.S. reports approximately 25 million asthma patients.[1]
- Inhaled corticosteroids (ICS): The primary therapeutic class for asthma; global inhaled corticosteroid market was valued at USD 4.1 billion in 2021.[2]
- Market share: Beclomethasone products constitute about 15% of the ICS market in the U.S., with the rest divided among fluticasone and budesonide.
Key competitors
- Flovent (fluticasone propionate)
- Pulmicort (budesonide)
- Qvar (beclomethasone dipropionate, but different formulation)
Regulatory and formulary considerations
- FDA status: Approved for maintenance treatment of asthma.
- Payor coverage: Widely covered by Medicaid, Medicare, and private insurers.
- Generics: Limited recent generic entries, but potential for future generic approvals.
Pricing context
- Brand price (current): Approximately USD 300–350 for a 120-inhaler package.
- Generic options: Available at lower prices, around USD 200–250, with many competing products.
Price Projections
Short-term (1-2 years)
- Market price stability: Due to limited generic competition, prices are likely to hold between USD 300–350.
- Potential discounts: Manufacturers may offer rebates and coupons to maintain market share, possibly reducing net price by 10–15%.
Medium-term (3-5 years)
- Generic market entry: Anticipated patent expiry or market exclusivity end by 2024–2026 could introduce generics.
- Impact on pricing: Generic entry is expected to reduce list prices by 20–40%; actual net prices may fall by 25–50% with rebates and pharmacy benefits.
- Market growth: Slight expansion in brand and generic sales expected due to increasing asthma diagnoses.
Long-term (5+ years)
- Market saturation: Growth impacted by new therapies (biologics) and combination inhalers.
- Pricing trend: List prices could decline to USD 150–200, with net prices further decreasing after rebates.
- Market share shifts: Predominance of branded versus generic depends on regulatory approvals and formulary decisions.
Regulatory and Policy Impact
- Price regulation: Potential for government intervention and increased price transparency measures.
- Reimbursement policies: Changes in insurance formularies may accelerate shifts toward generics.
Market Drivers and Barriers
Drivers
- Rising asthma prevalence
- Increasing adoption of inhaled corticosteroids
- Insurer preference for cost-effective generics
Barriers
- Limited generic options currently
- Brand loyalty among prescribers and patients
- Patent protections extending into the next few years
Key Takeaways
- NDC 49502-0394 (Soleo) maintains a strong position in the asthma inhaler market with current prices around USD 300–350.
- The advent of generics around 2024–2026 could reduce list prices by up to 40%.
- Short-term stability is expected, with medium to long-term declines driven by patent expiration and increased generic competition.
- Market growth depends on asthma prevalence trends, formulary preferences, and regulatory changes.
FAQs
Q1. When is the expected patent expiry for Soleo?
Patent protection is valid until approximately 2024–2025, paving the way for generic competition.
Q2. How much could prices decrease with generic entry?
List prices could drop 20–40%; net prices may decrease by up to 50% with insurance rebates.
Q3. What are the main competitors to Soleo?
Fluticasone (Flovent) and budesonide (Pulmicort) dominate the inhaled corticosteroid segment.
Q4. How does insurance coverage influence pricing?
Insurance formulary placements and rebate agreements significantly impact out-of-pocket costs for patients.
Q5. Are there patent challenges or litigation risks?
There are no known active patent litigations; future patent challenges could influence launch timing of generics.
References
[1] CDC. (2020). Asthma Surveillance Data. Centers for Disease Control and Prevention. https://www.cdc.gov/asthma/default.htm
[2] Grand View Research. (2022). Inhaled Corticosteroids Market Size, Share & Trends. https://www.grandviewresearch.com/industry-analysis/inhaled-corticosteroids-market
