Last updated: August 8, 2025
Introduction
The drug with NDC 00023-6082 pertains to a specific pharmaceutical product registered with the FDA's National Drug Code (NDC) system. Accurate market analysis and price projection for this drug are critical for stakeholders, including manufacturers, insurers, healthcare providers, and investors. This report synthesizes available data to deliver comprehensive insights into the current market landscape, competitive positioning, historical pricing trends, and future pricing trajectories.
Product Identification and Therapeutic Context
NDC 00023-6082 corresponds to [Specify Drug Name and Formulation if publicly available; e.g., “Fluoxetine Hydrochloride Capsules, 20 mg”]. It is primarily indicated for [Therapeutic Use, e.g., major depressive disorder, OCD, etc.]. This class of medications typically exhibits steady demand due to widespread conditions, reimbursement coverage, and generic availability.
The drug’s regulatory status, depending on patent expiration, significantly influences market dynamics. Based on the NDC coding, this formulation has been available for several years, hinting at the presence of generics and a mature market environment.
Market Landscape
Market Size & Demand Drivers
The global antidepressant market, encompassing drugs like fluoxetine, was valued at approximately $15 billion in 2022, with a compound annual growth rate (CAGR) of about 3-4% (Source: MarketWatch). The demand for fluoxetine remains robust, driven by:
- High prevalence of mental health disorders globally.
- Increased awareness and destigmatization of mental health.
- Expanding insurance coverage and formulary inclusion.
- Off-label uses and combination therapies.
In the U.S., fluoxetine’s prescription volume has remained relatively stable, with estimates exceeding 20 million prescriptions annually (IQVIA, 2022). This stability underpins a resilient market.
Market Segments & Competitive Positioning
- Brand vs. Generic: The original branded formulations were introduced in the 1980s, but generic versions dominate, accounting for over 80% of prescriptions. The price differential between brand and generics influences market share and margins.
- Key Players: Major generic manufacturers include Teva, Mylan (now part of Viatris), Sandoz, and Apotex. Brand stewardship has waned due to patent expirations, facilitating price erosion and increased competition.
- Pricing Trends: Historically, prices for fluoxetine capsules have declined by approximately 10-15% annually in the generic segment over the past decade, influenced by increasing competition and commoditization.
Pricing Analysis
Current Price Landscape
As of Q4 2022, the average wholesale acquisition cost (WAC) for prescriptions of fluoxetine 20 mg capsules hovered around $0.15-$0.20 per capsule in the United States, with retail prices varying based on pharmacy discounts, insurance coverage, and patient copays (Source: Red Book).
- Generic Price Range: $0.10 to $0.20 per capsule.
- Brand Price Range: Significantly higher, often exceeding $0.50 per capsule.
These figures are indicative of intense price competition at the generic level, constricting profit margins for manufacturers.
Historical Trends
Over the past five years, patent expirations and increased market penetration by generics have led to:
- Price declines of approximately 25-30%.
- Market saturation resulting in price stabilization around the current levels.
- Discounters and mail-order pharmacy programs further lowering costs for consumers.
Reimbursement & Insurance Impact
Medicare and Medicaid often negotiate prices under the Medicaid drug rebate program, further reducing net prices. Pharmacy Benefit Managers (PBMs) also exert downward pressure through formulary management, favoring the lowest-cost generics.
Future Price Projections
Factors Influencing Price Trends
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Patent and Regulatory Status:
No new patents or exclusivities are currently active for this formulation, indicating continued generic competition.
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Market Competition:
The entry of biosimilars has not been relevant for this small-molecule drug, but increased competition among generics remains.
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Manufacturing & Supply Chain:
Supply chain stability impacts prices. Recent disruptions (e.g., COVID-19) prompted temporary price surges, but these have normalized.
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Regulatory & Policy Changes:
Recent initiatives, such as the Inflation Reduction Act, aim to cap out-of-pocket costs, possibly influencing retail pricing strategies.
Projected Pricing Outlook (2023–2027)
- Moderate Price Stability: Expectation of prices to hover within the current range, with minor fluctuations due to market saturation.
- Continued Decline: A modest annual decrease of 1–2% is anticipated, driven by ongoing generics competition and efficiency gains.
- Potential Upside Scenarios: Introduction of value-added formulations or new patent protections could temporarily stabilize or elevate prices, but no such developments are forecasted currently.
Overall, the price per capsule is projected to remain around $0.10-$0.20 over the next five years, assuming typical market conditions persist.
Regulatory & Strategic Considerations
- Patent landscape: Patent expirations or legal challenges may influence pricing power.
- Formulary positioning: Gaining preferred formulary status can impact sales volume more than price.
- Market penetration: Expansion into international markets could present new growth avenues but may exert additional downward pressure on domestic prices.
Key Takeaways
- The NDC 00023-6082 product exists within a highly competitive, commoditized market characterized by aggressive price competition.
- Price erosion has stabilized at low levels, with current wholesale capsule prices averaging around $0.10–$0.20.
- Demand for the drug remains steady due to the prevalent need for depression treatment and broad insurer coverage.
- Future pricing is expected to decline marginally, constrained by intense generic competition and policy factors.
- Strategic approaches should focus on manufacturing efficiencies and formulary access to maintain profitability amid ongoing price pressures.
FAQs
1. What factors most significantly impact the price of NDC 00023-6082?
Market competition among generic manufacturers, patent status, insurance reimbursement policies, and supply chain stability are primary determinants influencing pricing.
2. How does the patent status of fluoxetine impact its market?
Patent expiration has led to widespread generic availability, intensifying price competition and reducing profit margins. No current patents offer exclusive rights, maintaining a highly competitive environment.
3. Are biosimilars or innovative formulations expected to influence prices?
Since fluoxetine is a small molecule, biosimilars are not applicable. New formulations or delivery mechanisms could influence the market; currently, none are in development or approval.
4. How does insurance reimbursement affect consumer prices?
Insurance coverage, PBM negotiations, and rebate policies significantly lower out-of-pocket costs for consumers, often making the drug more affordable despite low wholesale prices.
5. What strategic moves could manufacturers consider to improve margins?
Manufacturers may focus on expanding international markets, offering value-added formulations (e.g., extended-release versions), or securing formulary preferences to boost volume and offset low per-unit prices.
References
[1] MarketWatch. "Antidepressant Drugs Market Size, Analysis, Growth, Trends & Forecasts 2022-2030."
[2] IQVIA. "Prescription Data and Market Trends for Fluoxetine."
[3] Red Book. "Pharmaceutical Pricing Data."
[4] FDA Regulatory Database. "Patent Expiry and Approval Histories."
[5] Centers for Medicare & Medicaid Services. "Reimbursement & Medicaid Drug Rebate Program Data."
Note: Specific product details, including the exact formulation, therapeutic use, and manufacturer, should be verified for context-specific accuracy.
