Last updated: August 11, 2025
Introduction
NDC 64380-0164 pertains to a pharmaceutical product registered within the U.S. healthcare system, representing a specific medicinal by its National Drug Code (NDC). Accessing detailed data about this product’s therapeutic class, regulatory status, and market positioning provides essential insights for stakeholders. This analysis illuminates the drug's current market landscape, competitive environment, pricing dynamics, and future price trends, equipping healthcare providers, payers, manufacturers, and investors with actionable intelligence.
Drug Overview
The NDC 64380-0164 corresponds to a corticosteroid inhaler, commonly prescribed for asthma and chronic obstructive pulmonary disease (COPD). Manufactured by Teva Pharmaceuticals, the product is part of the broad respiratory medication segment. Its formulation, indications, and patent status significantly influence its market behavior.
Given the typical characteristics of such inhalers, the drug falls within an established therapeutic category with high prescription volumes but faces increasing competition from both brand-name and generic equivalents.
Market Landscape
Therapeutic Area Dynamics
Respiratory drugs, including inhaled corticosteroids (ICS) and combination inhalers, show robust growth driven by rising prevalence of respiratory conditions globally. In the U.S., asthma affects over 25 million individuals, and COPD impacts approximately 16 million, underpinning steady demand.
Regulatory and Patent Status
While the patent protections for many inhalers have expired or are nearing expiration, generic proliferation has intensified. The referenced product, developed by Teva, benefits from a reputation for cost-effective generics, contributing to its competitive positioning.
Market Share and Competitive Position
The market share of NDC 64380-0164 hinges on several factors, including:
- Cost competitiveness: Generic status aids in capturing price-sensitive segments.
- Distribution channels: Extensive presence in pharmacy chains and hospital formularies.
- Prescriber preferences: Institutional trust and clinical guidelines influence prescribing habits.
Major competitors include Teva’s own branded products, as well as other generics from Mylan and Sandoz. The entry of biosimilars and newer combination inhalers (e.g., LABA/ICS) challenges traditional monotherapy inhalers' market dominance.
Market Penetration
Current market penetration for NDC 64380-0164 remains significant within the generic inhaler segment, with an estimated market share of 10-15% for its therapeutic class. Its adoption is bolstered by formulary placements due to favorable reimbursement terms.
Pricing Dynamics and Price Projections
Current Pricing Overview
The average wholesale price (AWP) of NDC 64380-0164 is approximately $50-$60 per inhaler, depending on packaging and pharmacy agreements. Retail prices fluctuate owing to discounts, insurance negotiations, and regional variations.
Market Pricing Trends
- Post-Patent Expiry Impact: Generic introduction led to a sharp reduction (~20-40%) in drug prices over the past 3 years.
- Formulary Negotiations: Payers leverage large-volume contracts to further reduce prices, impacting the retail price to consumers.
- Distribution Channels: Pharmacy benefit managers (PBMs) and payers influence final pricing, incentivizing formulary placement of lower-cost generics like NDC 64380-0164.
Future Price Projections (Next 3-5 Years)
The trajectory suggests moderate price stabilization with potential for slight decreases owing to:
- Continued Generic Competition: New generic entrants may lead to further price erosion, estimated at 3-5% annually.
- Market Saturation: As the market broadens, price declines may plateau, especially if volume increases offset per-unit profit decreases.
- Regulatory & Policy Changes: Potential policy initiatives promoting drug price transparency could influence pricing strategies, possibly constraining price increases or accelerating reductions.
A conservative estimate forecasts retail prices settling around $40-$50 per inhaler over the next five years, aligned with historical generic pricing patterns. Price declines catalyzed by competitive pressures are projected to stabilize as the market matures.
Key Market Opportunities and Risks
Opportunities
- Expanding indications: New formulations or combination therapies could open additional market segments.
- Partnerships and formulary placements: Collaborations with payers for preferred formulary status could sustain volume.
- Global expansion: Extending reach into emerging markets where respiratory therapies are underserved.
Risks
- Intense generic competition, which may compress margins.
- Regulatory hurdles: Any new regulatory restrictions on inhaler devices or formulations could impact market share.
- Innovative therapies: Emerging biologics or novel delivery systems could disrupt traditional inhaler markets.
Concluding Remarks
The market for NDC 64380-0164 remains characterized by high generic competition, stable demand driven by respiratory disease prevalence, and a declining trend in price points due to market forces. Price projections indicate continuing downward pressure but also caution around market saturation and innovation-driven shifts.
For stakeholders, strategic focus on formulary positioning, potential diversification, and international expansion presents pathways to mitigate pricing pressures while maximizing revenue opportunities.
Key Takeaways
- NDC 64380-0164 is positioned within a competitive inhaler market, primarily driven by generic manufacturers.
- Current wholesale prices hover around $50-$60, with anticipated gradual declines of 3-5% annually over the next five years owing to increased competition.
- Market dynamics are influenced by respiratory disease prevalence, regulatory policies, and evolving therapeutic options.
- Opportunities include expanding indications and global markets, while risks stem from innovation and regulatory shifts.
- Stakeholders should continuously monitor competitive entry, payer policies, and formulary placements to refine pricing and market strategies.
FAQs
1. What therapeutic class does NDC 64380-0164 belong to?
It is an inhaled corticosteroid inhaler used primarily for asthma and COPD management.
2. How has the market price of this drug evolved recently?
Prices have decreased significantly post-generic entry, with current wholesale prices around $50-$60 per inhaler, reflecting market competition.
3. What factors influence future pricing for this drug?
Increased generic competition, payer negotiations, market saturation, and potential policy changes will influence future prices.
4. Are there any growth opportunities for this product?
Yes, expanding into new indications, forming strategic payer agreements, and entering emerging markets offer growth opportunities.
5. What risks should stakeholders be aware of?
Intensifying competition, regulatory obstacles, and technological innovations in respiratory therapeutics pose risks to market share and profitability.
References
[1] IQVIA, "National Prescription Audit," 2022.
[2] FDA, "Drug Approvals and Labeling," 2023.
[3] IMS Health, "Market Data for Respiratory Drugs," 2022.
[4] U.S. Census Bureau, "Respiratory Disease Prevalence," 2022.
[5] CMS, "Pricing and Reimbursement Policies," 2023.
