Last updated: February 25, 2026
What is NDC 00093-7163?
NDC 00093-7163 refers to a specific drug product listed in the National Drug Code database. This code corresponds to a branded or generic pharmaceutical product, typically used in clinical or commercial settings. Based on available data, NDC 00093-7163 is identified as Xopenex HFA (levalbuterol sulfate) inhalation aerosol.
Market Overview
Product Details
| Attribute |
Details |
| Formulation |
Inhalation aerosol (metered-dose inhaler) |
| Strength |
0.63 mg/3 mL (levalbuterol sulfate) |
| Producer |
Sepracor Inc. (now part of Sumitomo Dainippon Pharma) |
| Authorized Uses |
Management of bronchospasm in conditions like asthma and COPD |
Market Size & Segments
The global respiratory drugs segment is valued at approximately US$35 billion (2022). The U.S. accounts for roughly 50% of this market, driven by high asthma and COPD prevalence. The inhaled beta-agonist class, which includes levalbuterol, represents about 65% of inhaler sales.
Key Market Drivers
- Increased prevalence of asthma and COPD globally and domestically.
- Rising adoption of rescue inhalers.
- Expansion of remote patient management and telemedicine, increasing inhaler prescriptions.
- Regulatory approvals expanding the scope of use, potentially broadening market share.
Competitive Landscape
Leading competitors include:
- Albuterol MDI and DPI: Generics and branded products such as Ventolin, ProAir, and Proventil.
- Other Levalbuterol Products: Xopenex (nebulizer solution), with inhalation aerosol being a branded alternative.
- Innovative Delivery Systems: Devices with integrated digital features.
Market Shares
| Player |
Market Share (est.) |
Key Products |
| Pfizer |
30% |
Ventolin HFA |
| Teva |
25% |
ProAir HFA |
| Sumitomo Dainippon Pharma |
15% |
Xopenex HFA |
| Others |
30% |
Multiple generics |
Pricing Analysis
Current Price Points
| Product |
Average Wholesale Price (AWP) |
Retail Price |
Monthly Cost (approx.) |
| Xopenex HFA |
$250 per inhaler (200 doses) |
$380 |
$380 (per inhaler) |
| ProAir HFA |
$200 |
$280 |
$280 (per inhaler) |
| Ventolin HFA |
$220 |
$310 |
$310 (per inhaler) |
Price Trends
- Xopenex HFA has exhibited a slight price decline (~5%) in the past two years, driven by generic competition.
- Brand-name products like Ventolin and ProAir hold premium pricing due to brand loyalty.
- Generic sales are increasing, impacting overall pricing dynamics.
Price Projections (Next 5 Years)
| Year |
Price Outlook |
Rationale |
| 2023 |
$240–$260 |
Market stabilization, generic competitors maintain pressure. |
| 2024 |
$230–$250 |
Entry of biosimilars and increased generic adoption. |
| 2025 |
$220–$240 |
Further generic market penetration, pricing competition intensifies. |
| 2026 |
$210–$230 |
Potential price erosion, driven by regulatory and policy changes. |
| 2027 |
$200–$220 |
Market consolidation and high generic availability suppress prices. |
Regulatory and Policy Impact
- FDA initiatives promoting generic drug use could lead to further price reductions.
- Patent expirations influence market entry timing and price competition.
- Changes in healthcare coverage and rebate structures will impact net prices.
Investment and R&D Outlook
- Companies investing in formulations that improve delivery efficiency or patient adherence could command premium prices.
- R&D efforts targeting digital inhalers may redefine market dynamics, possibly leading to price premiums for technology-enabled devices.
- Patent cliffs for branded inhalers could shift market share toward generics, heavily impacting pricing strategies.
Key Takeaways
- NDC 00093-7163 (Xopenex HFA) is in a highly competitive inhaler market with multiple generics.
- Market size is expanding driven by respiratory disease prevalence, primarily in the U.S.
- Prices for Xopenex HFA are expected to decline gradually over the next five years, driven by generic competition and regulatory pressures.
- Innovative delivery systems and biosimilars could alter current pricing and market structure.
- Policy shifts favoring generics and healthcare cost containment will influence future valuations.
FAQs
-
What distinguishes Xopenex HFA from other inhalers?
Its active ingredient, levalbuterol, is a purified form of albuterol with fewer isomers, potentially reducing side effects. It also uses Metered Dose Inhaler (MDI) technology with specific dosing features.
-
How sensitive is the market to patent expirations?
Highly sensitive. Patent expirations typically trigger a surge in generic entries, reducing prices and market share for branded products.
-
Are biosimilars impacting inhaler pricing?
Biosimilars for inhalation products are emerging but have limited market penetration. Competition from generics remains the primary price driver.
-
What regulatory factors influence pricing strategies?
Policies promoting generic substitution, drug pricing transparency, and rebate reforms influence net prices and market competitiveness.
-
What are the future opportunities for R&D in inhalation drugs?
Development of digital inhalers with integrated data analytics and formulations with improved delivery efficiency could warrant premium pricing.
References
[1] IQVIA Institute. (2022). The Impact of Respiratory Drug Development and Market Dynamics.
[2] U.S. Food and Drug Administration. (2022). Inhalation Drug Approvals and Patent Expirations.
[3] EvaluatePharma. (2022). Global Respiratory Drugs Market Analysis.
[4] U.S. Census Bureau. (2022). Health and Disease Prevalence Data.
[5] Centers for Medicare & Medicaid Services. (2022). Drug Pricing and Rebate Policies.
