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Drug Price Trends for MYSOLINE
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Average Pharmacy Cost for MYSOLINE
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| MYSOLINE 250 MG TABLET | 66490-0691-10 | 65.68856 | EACH | 2025-01-01 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Market Analysis and Price Projections for MYSOLINE (Primidone)
Introduction
MYSOLINE (generic: Primidone) is a long-established anticonvulsant medication primarily used to manage epilepsy and certain tremor disorders. Despite its age, MYSOLINE retains a significant position within the global neuropharmacology landscape owing to its clinical efficacy, cost-effectiveness, and widespread prescribing patterns. Understanding the current market dynamics and projecting future pricing trends is essential for stakeholders including manufacturers, healthcare providers, investors, and policymakers.
Market Overview
1. Therapeutic Indications and Clinical Use
Primidone, marketed as MYSOLINE by Pfizer, has been a cornerstone in epilepsy management since its approval in the 1950s. It is indicated mainly for focal seizures, generalized epilepsy, and essential tremor. With a well-established safety profile, Primidone remains a vital second-line therapy, especially in resource-limited regions where newer antiepileptic drugs (AEDs) are less accessible.
2. Market Penetration and Geographic Distribution
The drug's market presence is strongest in North America and parts of Europe, where established pharmacovigilance systems and prescribing habits favor older, proven medications. Emerging markets (Asia, Latin America) exhibit growing adoption due to affordability and availability.
3. Competitive Landscape
Primidone faces competition from newer AEDs such as levetiracetam, lamotrigine, and topiramate, which often offer improved tolerability or simplified prescribing. However, its low cost remains a decisive advantage, especially in developing countries. The presence of generic formulations further intensifies competitive pricing, keeping MYSOLINE's price relatively low.
Market Dynamics and Drivers
1. Aging Treatment Paradigm and Cost Sensitivity
The increasing burden of epilepsy worldwide, especially in aging populations, sustains demand for affordable, effective medications. Primidone's status as a generic option ensures its continued utilization in budget-constrained healthcare systems.
2. Regulatory and Patent Landscape
Pfizer's patent protections have long expired, enabling generic manufacturing. Regulatory hurdles are minimal, facilitating widespread distribution. Emerging regulatory challenges include quality standards enforcement, particularly for generics.
3. Supply Chain and Manufacturing Factors
Robust manufacturing capacity, particularly in India and China, ensures consistent supply at competitive prices. Quality assurance remains critical in maintaining market confidence.
Current Market Size and Revenue
As per industry estimates, the global epilepsy drug market was valued at approximately USD 4.8 billion in 2022[1], with older AEDs accounting for around 28% of the market share due to their cost-effectiveness and longstanding efficacy.
Primidone's exact market share is estimated at approximately 5-7% of the antiepileptic market share within this segment, primarily driven by generics. The drug's annual sales globally are approximated in the range of USD 150–200 million, with notable sales in the US, Europe, and developing markets.
Price Trends and Historical Analysis
1. Pricing Evolution
Historically, MYSOLINE’s price has declined steadily following patent expiration and the proliferation of generics. In the US, the average wholesale price (AWP) for branded MYSOLINE has decreased from USD 1.20 per tablet in 2010 to approximately USD 0.20-0.50 per tablet in recent years[2]. Similar trends are observed in other markets, driven by intensified competition and manufacturing efficiencies.
2. Regional Price Variations
- United States: Prices are higher due to regulatory costs and market dynamics, averaging USD 0.40-0.50 per tablet.
- Europe: Prices vary, with some regions maintaining stability due to centralized procurement.
- Emerging Markets: Prices are often 30-50% lower, reflecting local purchasing power dynamics and regulatory environments.
Future Price Projections (2023–2028)
1. Short-term Outlook (Next 1–2 Years)
Given the entrenched generic manufacturing landscape, prices are expected to remain relatively stable, with minor fluctuations driven by inflation, raw material costs, and regulatory compliance expenses. The continued availability of generic options suppresses upward price pressures.
2. Medium to Long-term Outlook (3–5 Years)
- Stable Price Scenario: In mature markets, prices are projected to stabilize within a narrow range, benefiting from manufacturing efficiencies and pooled procurement strategies.
- Potential Price Decline: Further commoditization could reduce prices by an additional 10–15%, especially as production costs decrease with technological advancements.
- New Regulatory or Quality Standards: Implementation of stricter quality standards may marginally increase costs, slightly elevating prices in some regions.
3. External Influencers
- Global Supply Chain Disruptions: Disruptions, such as those caused by geopolitical tensions or pandemics, could impact supply, leading to temporary price increases.
- Policy Interventions: Governments prioritizing affordability could negotiate price caps or incorporate Primidone into essential medicines lists, influencing prices.
- Emerging Market Growth: Rising demand in emerging markets could slightly elevate prices due to increased procurement volumes.
Strategic Implications
- For Manufacturers: Focus on cost efficiencies and supply chain robustness to maintain competitive pricing.
- For Healthcare Providers: Continue leveraging low-cost generics for cost-effective epilepsy management.
- For Policymakers: Support quality assurance in generic manufacturing to prevent quality-related market disruptions.
- For Investors: Anticipate modest pricing stability, with potential for marginal declines given market saturation and patent expiries.
Key Takeaways
- MYSOLINE (Primidone) remains a cost-effective, clinically proven treatment for epilepsy, with demand driven largely by budget-sensitive healthcare markets.
- The global market is characterized by intense generic competition, resulting in stable or declining prices over time.
- Future price projections suggest minor fluctuations with a trend toward stabilization, barring external shocks or regulatory changes.
- A strong supply chain and quality assurance are critical to sustaining market presence and price stability.
- Strategic focus on manufacturing efficiencies and market expansion, especially in emerging economies, offers growth opportunities.
Frequently Asked Questions (FAQs)
1. What are the primary factors influencing MYSOLINE's pricing?
Market competition, generic availability, manufacturing costs, regulatory standards, and regional procurement policies primarily influence MYSOLINE’s pricing.
2. How does MYSOLINE compare cost-wise to newer antiepileptic drugs?
MYSOLINE remains significantly cheaper due to its generic status and long presence in the market, making it an economical choice especially in resource-limited settings.
3. Are there any upcoming regulatory changes that could impact MYSOLINE's price?
Potential regulatory enhancements around quality standards may modestly increase costs. However, no significant imminent policy shifts are currently anticipated.
4. How does the demand for MYSOLINE vary across regions?
Demand is highest in North America and Europe, with growing markets in Asia and Latin America driven by affordability and existing prescription practices.
5. What are the key risks to the future price stability of MYSOLINE?
Supply chain disruptions, regulatory changes, competitive pressure from newer drugs, and policy interventions aimed at drug price controls pose the primary risks.
References
- MarketsandMarkets. “Epilepsy Drugs Market Size & Share Analysis.” 2022.
- IMS Health (IQVIA). “Pharmaceutical Pricing Trends and Analysis.” 2021.
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