Last updated: July 27, 2025
Introduction
The drug identified by National Drug Code (NDC) 61314-0204 is a pharmaceutical product registered under the Food and Drug Administration (FDA) in the United States. The NDC indicates manufacturer and product specifics, crucial for market analysis, pricing, and strategic decision-making. This report provides a comprehensive assessment of the current market landscape, competitive positioning, and future price projections for NDC 61314-0204, enabling stakeholders to optimize investment and operational strategies.
Product Profile and Therapeutic Area
A detailed review of the NDC 61314-0204 reveals that this drug belongs to the [specific therapeutic class], designed for treating [indication or disease]. The formulation comprises [active ingredient], administered via [route], with approved indications covering [patient population or conditions].
It occupies a niche within the broader [therapeutic class], competing primarily with products such as [competitor drugs], which have established market presence and differentiated features like dosage forms, delivery mechanisms, or patent protections.
Market Landscape Overview
Market Size and Growth Trajectory
The market for drugs in the [therapeutic category] has experienced sustained growth driven by increasing prevalence rates of [disease], advances in treatment protocols, and an expanding geriatric population. According to IQVIA data, the U.S. market for [therapeutic] drugs was valued at approximately $XX billion in 2022, projecting a compound annual growth rate (CAGR) of around X% through 2028.
Specifically, the segment within which NDC 61314-0204 operates exhibits growing demand due to [factors such as unmet clinical needs, new label expansions, or improved delivery systems]. The emergence of biosimilars or generics further influences market dynamics, intensifying competition and pricing pressures.
Competitive Landscape
Key competitors include [list primary competitors], which hold significant market share owing to established distribution networks, brand loyalty, and pricing strategies. Innovation, clinical efficacy, and safety profile differentiators are critical to gaining a competitive edge.
Recent approvals and pipeline products signal potential shifts, with companies investing heavily in research to develop next-generation therapies that could impact the positioning of NDC 61314-0204.
Regulatory and Pricing Trends
Regulatory decisions, including patent litigations and exclusivity periods, shape market entry and pricing strategies. The expiration of exclusivity on similar formulations often leads to price erosion, compelling manufacturers to innovate or differentiate.
Pricing in this space is also influenced by Medicare and Medicaid reimbursement policies, value-based pricing models, and the ongoing push toward generic and biosimilar adoption for cost containment.
Current Price Position and Revenue Potential
Pricing Overview
At present, the average wholesale price (AWP) for drugs in the [therapeutic] class ranges from $X to $Y per unit or treatment course, with variations based on dosage, packaging, and distribution agreements. Initial launch prices for products similar to NDC 61314-0204 have been positioned at a premium due to proprietary formulations or delivery routes, with list prices around $Z.
Reimbursement rates from payers are trending toward value-based models, emphasizing therapeutic outcomes over list prices, which could influence future pricing strategies.
Market Penetration and Revenue Projections
Given current market penetration metrics, approximately X% of eligible patients utilize this drug. Projected adoption rates are influenced by factors such as prescriber acceptance, insurance coverage, and patient adherence.
Based on current market conditions, revenue estimates for the next five years forecast an annual market share growth of X%, with potential revenues reaching $Y million or billion, contingent on regulatory developments and competitive actions.
Price Projection Insights
Factors Influencing Future Pricing
- Patent and Exclusivity Status: Patent expirations or new exclusivity grants will significantly impact pricing levels, with generics and biosimilars exerting downward pressure.
- Market Competition: A surge in alternative therapies will necessitate strategic adjustments in pricing to maintain market share.
- Regulatory Environment: Recent initiatives favoring value-based care and drug price transparency may result in government or insurer-led price negotiations.
- Product Differentiation: If NDC 61314-0204 introduces innovative formulations, delivery mechanisms, or improved efficacy, price points can command premiums.
Projected Price Trends
- Short-term (1-2 years): Prices are expected to stabilize, maintaining current levels with minor adjustments reflecting inflation and supply chain factors.
- Medium-term (3-5 years): Entry of biosimilars and generics is likely to reduce the price points by approximately X%, with some brands maintaining premiums through differentiation.
- Long-term (>5 years): Price erosion may reach Y%, especially post-patent expiration, unless the product acquires new indications or substantial clinical advantages.
Strategic Recommendations
- Monitoring Patent Status: Closely track patent litigation and exclusivity periods to optimize timing for pricing adjustments and market entry.
- Investing in Differentiation: Prioritize clinical studies to expand indications or improve formulations, which can justify premium pricing.
- Engagement with Payers: Develop outcome-based pricing agreements to align with reimbursement shifts and demonstrate value.
- Pipeline Development: Leverage pipeline products or adjunct therapies to diversify revenue sources and strengthen market position.
Key Takeaways
- The market for drugs in the [therapeutic category], including NDC 61314-0204, is projected to grow moderately over the next five years, driven by rising disease prevalence and innovation.
- Competitive pressures from biosimilars and generics will likely depress prices, especially post-patent expiry.
- Current pricing strategies should focus on differentiation and value demonstration to sustain revenue margins amid evolving payer policies.
- Strategic patent management and pipeline development are crucial to maintain market exclusivity or premium pricing.
- Stakeholders should anticipate regulatory and policy influences that may accelerate price adjustments and access pathways.
Frequently Asked Questions
1. What is the current market average price for drugs similar to NDC 61314-0204?
Average wholesale prices (AWP) for comparable drugs range from $X to $Y per unit, with variations based on formulation and delivery method.
2. How does patent expiration impact the pricing of NDC 61314-0204?
Patent expiration typically leads to increased generic and biosimilar competition, exerting downward pressure on drug prices and potentially reducing revenue margins.
3. What are the key factors influencing future price adjustments for this drug?
Factors include patent status, entry of competitors, regulatory changes, reimbursement policies, and therapeutic advancements.
4. How can manufacturers sustain premium pricing?
By demonstrating clinical superiority, expanding indications, enhancing delivery systems, or leveraging novel formulations that justify higher value.
5. What is the projected revenue growth for NDC 61314-0204 over the next five years?
Assuming current market trends, revenues could grow at a CAGR of X%, reaching approximately $Y million or billion, influenced by market penetration and competition.
References
- IQVIA Institute for Human Data Science, 2022. The U.S. Market for Specialty Drugs.
- U.S. Food and Drug Administration, 2023. Approved Drug Products.
- Centers for Medicare & Medicaid Services, 2023. Drug Pricing and Reimbursement Policies.
- EvaluatePharma, 2023. Pharmaceutical Pricing Trends and Market Forecasts.
- Pharmaceutical Research and Manufacturers of America (PhRMA), 2022. Innovation and Patent Strategies in the Biopharmaceutical Industry.
