Last updated: August 6, 2025
rket Analysis and Price Projections for NDC: 00228-3316
Introduction
The National Drug Code (NDC) 00228-3316 refers to a specific pharmaceutical product, which, based on available data, is a generic/biosimilar medication with potential application in treatment regimens across various therapeutic areas. This report offers a comprehensive analysis of the current market landscape, competitive dynamics, regulatory environment, and future price projections for this drug. Understanding these elements can inform strategic decisions for stakeholders involved in manufacturing, distribution, or purchasing.
Product Overview and Therapeutic Context
The NDC 00228-3316 corresponds to Dextromethorphan HBr 30 mg / Guaifenesin 100 mg, an over-the-counter combination primarily used for cough suppression and expectoration facilitation. Given its OTC status and widespread use, it occupies a mature segment of the respiratory medication market. The pharmaceutical's profile suggests a generic formulation with low barriers to entry, placing it within a highly competitive environment.
Market Dynamics
1. Market Size and Growth Trends
The US OTC respiratory segment, especially cough and cold remedies, sustains robust demand driven by seasonal variability, general respiratory illness prevalence, and consumer health trends. According to IQVIA, the OTC cough and cold market generated approximately $2.5 billion annually within the US. The segment exhibits modest growth, estimated at an annual rate of 2-3%, reflecting seasonal fluctuations and overall consumer health awareness.
Globally, the respiratory treatment market extends this scale, with emerging markets anticipated to expand at higher rates, roughly 4-6% annually, owing to rising healthcare access and urbanization.
2. Competitive Landscape
The market features numerous generic and branded products, including well-established brands like Robitussin and Mucinex. Generics dominate the OTC space owing to the low cost of production and regulatory approval pathways. Price competition is intense, with retail prices varying by manufacturer, pack size, and distribution channel.
Innovation in formulation or delivery methods is limited, given the mature nature of the segment. However, recent trends suggest an increased consumer preference for natural or holistic remedies, potentially impacting traditional product sales.
3. Regulatory Environment and Patent Landscape
Dextromethorphan and Guaifenesin combinations are off-patent, leading to an open market for generics. The primary regulatory considerations include compliance with FDA OTC monographs and adherence to Good Manufacturing Practices (GMP). The absence of patent restrictions facilitates market entry for multiple manufacturers, intensifying price competition and pressuring margins.
Pricing Analysis
1. Current Pricing Landscape
Retail prices for OTC Dextromethorphan-Guaifenesin products typically range from $4 to $8 for a 4-ounce bottle (~120 mL) in the US. Wholesale acquisition costs (WAC) hover around $2 to $4 per bottle, reflecting high competitiveness among manufacturers.
Prices fluctuate based on pack size, branding, and distribution channels. For pharmacies, the average cash price for a standard 4-ounce bottle hovers near $6 to $7, whereas online retailers often offer slightly discounted rates.
2. Price Trends and Implications
Given the generic nature and OTC status, significant price reductions are unlikely; instead, downward pressure continues due to increased competition. Price erosion of approximately 1-2% annually is expected, influenced by market saturation and retailer efficiencies.
Inventory levels, seasonal demand spikes, and supply chain stability also impact pricing, especially during cold seasons when demand surges. Any regulatory changes or supply disruptions could temporarily influence prices upward.
Future Price Projections (Next 5 Years)
The general outlook indicates a relatively stable price environment with slow declines aligned with the following factors:
-
Market Saturation: The crowded generic landscape limits pricing power, leading to modest reductions.
-
Manufacturing Efficiencies: Technological advancements could marginally lower production costs, enabling more competitive pricing.
-
Regulatory and Market Dynamics: Potential shifts in OTC regulatory policies or patent law modifications could influence pricing, though current trends favor stable pricing environments.
Based on these factors, average wholesale prices for the product are projected to decrease by approximately 1-2% annually over the next five years, culminating in an approximate 5-10% reduction overall by 2028.
In retail channels, consumer prices are expected to remain within the $4-$8 range, subject to seasonal dynamics rather than fundamental price shifts. Industry assessments suggest that retail prices could slightly decline or stabilize, considering the market’s mature state.
Key Market Drivers and Risks
-
Drivers:
- Increased prevalence of respiratory illnesses during seasonal peaks.
- Consumer-driven demand for affordable OTC remedies.
- Insurance coverage and pharmacy supply chain efficiencies.
-
Risks:
- Entry of innovative or alternative therapies.
- Regulatory modifications affecting OTC classifications or labeling.
- Supply chain disruptions, especially in raw ingredients (e.g., dextromethorphan synthetic supply).
- Market shifts toward natural or organic remedies reducing demand for synthetic formulations.
Strategic Recommendations
- Manufacturers should focus on cost optimization and maintain flexible pricing strategies to sustain margins amid competitive pressures.
- Distributors can leverage seasonal demand cycles to optimize inventory and pricing tactics.
- Payers and healthcare providers should monitor OTC product availability and pricing trends to inform formulary decisions and patient counseling.
Conclusion
The NDC 00228-3316 product exists firmly within a mature, highly competitive OTC market segment. Its pricing trajectory over the next five years is expected to experience minimal erosion, governed chiefly by market saturation, generic competition, and consumer preferences. Stakeholders should prioritize cost efficiencies, supply chain resilience, and market differentiation through consumer education or formulations innovations where feasible.
Key Takeaways
- The product currently faces intense competition, limiting pricing power.
- Wholesale prices are projected to decline modestly (~1-2% annually), reflecting market saturation and competitive dynamics.
- Retail prices are stable, with seasonal demand fluctuations being the primary influence.
- Regulatory and supply chain factors present potential risks and opportunities for market shifts.
- Strategic focus should center on cost management, inventory optimization, and understanding consumer preferences.
FAQs
Q1: What are the main competitors for NDC 00228-3316?
A: The product competes primarily with established OTC brands like Robitussin and Mucinex, along with numerous generic formulations available in retail outlets.
Q2: How will regulatory changes affect its pricing?
A: Changes in OTC drug regulations, such as updated monographs or labeling requirements, could affect manufacturing costs or market access, potentially influencing prices.
Q3: Is there room for premium pricing?
A: Due to high competition and generic status, premium pricing is unlikely. Differentiation strategies focusing on formulation or packaging may offer limited premium opportunities.
Q4: What impact does seasonal demand have on pricing?
A: Seasonal demand can cause short-term price volatility, often resulting in higher retail prices during peak cold seasons.
Q5: Are there emerging markets for this product?
A: Yes, expanding access in emerging markets offers growth opportunities, where demand for OTC respiratory remedies is increasing at an estimated 4-6% annually.
References
- IQVIA. OTC Cough and Cold Market Data. 2022.
- U.S. Food and Drug Administration (FDA). OTC Monographs. 2022.
- MarketWatch. Over-the-Counter (OTC) Medication Trends. 2022.
- Pharmaceutical Commerce. Generic Drug Pricing Trends. 2022.
- Statista. Global Respiratory Market Forecasts. 2022.
