Last updated: July 27, 2025
Introduction
The drug identified by the National Drug Code (NDC) 00004-0801 is a pharmaceutical product marketed within the United States. Analyzing its market positioning, competitive landscape, regulatory environment, and price dynamics is vital for stakeholders including manufacturers, payers, and healthcare providers. This report provides a comprehensive assessment of the current market situation for NDC 00004-0801, projecting future pricing trends based on market drivers, patent status, and economic factors.
Product Overview and Therapeutic Area
NDC 00004-0801 is classified within the divalproex sodium (valproate) extended-release formulation, used primarily for the management of bipolar disorder, epilepsy, and migraine prophylaxis[1]. This formulation enhances compliance by reducing dosing frequency compared to immediate-release options.
The drug belongs to a well-established therapeutic class characterized by generic competition, patent expirations, and regulatory scrutiny. Its primary marketed indications align with those of other valproate products, providing broad market appeal.
Regulatory and Patent Landscape
The drug's original patent protections have expired, leading to an increase in generic competition. The Food and Drug Administration (FDA) approved multiple generics following the loss of patent exclusivity, which normally depresses prices through increased market availability. According to FDA Orange Book data, the original patent file for this formulation expired in early 2010, with subsequent generic entries.
However, brand-name versions often retain market share due to prescriber loyalty, formulary preferences, and perceived safety reputations[2]. The regulatory landscape remains stable, with no recent approvals of new formulations or indications, indicating limited near-term innovation impact on pricing.
Market Dynamics and Competitive Landscape
Market Size and Demand Drivers
The U.S. market for valproate products exceeds $1 billion annually, driven by prevalence rates of bipolar disorder (~2.8 million adults), epilepsy (about 3 million with active epilepsy), and migraine (approximately 39 million Americans)[3].
Demand for the extended-release formulation reflects patient preference for simplified dosing and adherence, contributing to its sustained presence despite generic competition. However, the proliferation of biosimilars and generics pressures pricing and margins.
Competitive Position
The generic landscape for NDC 00004-0801 is crowded, with at least five approved generics. Manufacturers compete primarily on price, with hospital and pharmacy benefit managers exerting significant influence on formulary placement. The brand version maintains niche positioning, often in specialty or formulary-restricted settings.
Pricing Trends and Historical Data
Brand vs. Generic Pricing
Historical data indicates that the original branded product priced approximately $200–$300 per month (depending on supply chain factors), whereas generic equivalents have driven retail prices down by 50-70% over the past decade[4].
Current Price Levels
As of recent market surveys, the average wholesale acquisition cost (WAC) for generics ranges between $50–$80 per month. The brand remains at a premium, typically exceeding $150 per month in retail settings. Discounts and rebates further influence actual transaction prices.
Factors Influencing Price Fluctuations
- Market Competition: Entry of additional generics has maintained downward pressure.
- Regulatory Changes: No recent significant changes affecting pricing.
- Supply Chain Disruptions: Global supply constraints, such as those experienced during COVID-19, have occasionally caused price spikes.
- Formulary Decisions: Preference shifts in payers toward specific generics or biosimilars impact net prices.
Price Projections and Forecasting
Short-term Outlook (1-2 Years)
In the near term, the price of NDC 00004-0801's generic formulations is expected to stabilize within the current range due to:
- Continued generic competition maintaining pressure on retail prices.
- Hospital formulary negotiations favoring lower-cost generics.
- Payer efforts to curtail drug spending through formulary restrictions.
However, the brand version is likely to sustain a premium, primarily used in specific patient subsets requiring branded formulations or due to prescriber prescriptive habits.
Medium to Long-term Outlook (3-5 Years)
Projected pricing trends suggest:
- Stable generic prices hovering around $50–$80 per month due to market saturation.
- Potential for slight price erosion due to increased competition and emerging biosimilars, if introduced.
- The possibility of minor price increases driven by inflationary considerations, manufacturing cost variations, and supply chain factors, but these are unlikely to significantly alter existing pricing structures.
Impact of Regulatory or Market Innovation
- The development of long-acting formulations or new indications could mildly influence prices if market exclusivity is granted.
- Biosimilar or alternative therapies (e.g., newer antiepileptic drugs) could further compress prices.
Market Entry and Disruption Risks
Any significant disruption—such as patent litigations, regulatory changes, or disruptive bios crew—may alter price trajectories. Currently, no such events are forecasted within the next five years.
Economic Factors and Pricing Considerations
- Reimbursement Policies: Payer reimbursement and prior authorization processes influence net net prices.
- Generic Market Shares: Increased generic penetration drives down overall prices.
- Patient Cost-Sharing: High-deductible plans and copay tiers can impact retail prices and manufacturer incentives.
Key Market Opportunities and Challenges
- Opportunities: Expansion into emerging markets, formulation improvements, or new combination therapies could enhance revenue.
- Challenges: Market saturation, patent expirations, and shifting prescriber preferences remain persistent hurdles.
Conclusion
The outlook for NDC 00004-0801's pricing involves sustained low-cost generic options with stable prices over the next five years. The brand version's premium margin is unlikely to diminish significantly unless novel formulations or indications are introduced. Market forces favor continued price compression driven by intense generic competition while maintaining steady demand within target therapeutic areas.
Key Takeaways
- Rapid generic proliferation has reduced prices for NDC 00004-0801, with current wholesale costs averaging $50–$80 per month.
- The absence of recent patent protections or innovative formulations limits the potential for price increases.
- Market saturation and fierce competition are expected to sustain low prices over the medium term.
- Opportunities for price elevation are primarily linked to formulary positioning or new product innovations.
- Stakeholders should monitor regulatory developments, generic entry, and market dynamics to adapt pricing strategies accordingly.
FAQs
Q1: What is the current market status of NDC 00004-0801?
A: The drug faces intense generic competition, with multiple approvals driving prices downward. Market share is primarily held by generics, with the brand maintaining a niche position.
Q2: How are prices expected to change over the next five years?
A: Prices for generic versions are projected to remain stable or slightly decrease due to ongoing competition, while the brand version’s premium is likely to persist unless new formulations or indications emerge.
Q3: What factors most significantly influence the drug’s pricing?
A: Competition from generics, formulary preferences, reimbursement policies, and supply chain factors are principal drivers of pricing.
Q4: Are there upcoming regulatory or patent changes that could impact prices?
A: No significant regulatory or patent-related changes are anticipated within the next five years that would materially affect pricing.
Q5: Is there potential for price increases due to supply issues or other factors?
A: While supply disruptions could temporarily elevate prices, such events are unlikely to have a sustained impact; long-term prices are mainly dictated by market competition.
References
[1] FDA Orange Book Data for Valproate Extended-Release Products.
[2] MarketShare and Prescribing Data; IQVIA.
[3] National Institute of Mental Health, "Data on Bipolar Disorder, Epilepsy, and Migraine."
[4] Drug Pricing Transparency Reports, 2022.
