Last updated: March 27, 2026
What is NDC 00046-1104?
NDC 00046-1104 refers to Entacapone, marketed as Comtan. It is a COMT inhibitor primarily used to improve motor function in Parkinson's disease patients by extending the half-life of levodopa.
Market Overview
Indications and Usage
- Parkinson's disease managing motor fluctuations.
- Typically prescribed with levodopa and carbidopa.
- Global prevalence of Parkinson's stands at approximately 9 million, with increasing diagnosis rates in aging populations [1].
Current Market Size
- The global Parkinson’s disease treatment market was valued at $3.4 billion in 2021.
- The compound annual growth rate (CAGR) is projected at 6.5% through 2030 [2].
Key Competitors
- Other COMT inhibitors: Tolcapone (Tasmar), Opicapone (Ongentys).
- Dopamine agonists, MAO-B inhibitors, and levodopa formulations.
Distribution and Sales Channels
- Pharma companies distribute through pharmacies, hospitals, and specialized clinics.
- The U.S. remains the dominant market, accounting for 50% of sales, followed by Europe and Asia.
Pricing History and Current Pricing Landscape
List Prices (Approximate)
- United States: The average wholesale price (AWP) for a 200 mg tablet is roughly $50-$70.
- Per Month Cost: For typical regimens (3x200 mg daily), patients face costs around $450–$630.
Insurance and Reimbursement
- Medicare Part D often covers Entacapone with co-payments varying between $10–$50.
- Commercial insurers follow similar coverage patterns.
Competitive Pricing
| Drug |
Typical Cost (per month) |
Notes |
| Entacapone |
$450–$630 |
Brand and generic pricing similar |
| Opicapone |
$400–$600 |
Slightly cheaper, newer approval in some markets |
| Tolcapone |
$300–$500 |
Less used due to hepatotoxicity concerns |
Regulatory Status & Market Dynamics
- Entacapone is FDA-approved (since 1999).
- Patent expirations occurred in early 2010s, leading to generic availability.
- Market growth driven by demographic shifts and rising Parkinson's prevalence.
Price Projections (Next 5 Years)
Factors Influencing Pricing
- Entry of generic formulations reduces prices.
- Rising demand from aging populations.
- Competitive pressures from newer drugs (e.g., Opicapone approved in 2016 in Europe, 2020 in the US).
- Regulatory discounts and policy changes affecting reimbursements.
Forecast Summary
| Year |
Estimated Price Range (per month) |
Notes |
| 2023 |
$430–$600 |
Slight decline due to generic competition |
| 2025 |
$400–$550 |
Increased market saturation with generics |
| 2027 |
$350–$500 |
Further downward pressure, new generics emerge |
| 2030 |
$300–$450 |
Stabilization at lower price points due to competition |
Key Drivers
- Price erosion from generics.
- Increasing economies of scale.
- Emerging biosimilar and alternative therapies.
Risks to Price Stability
- Patent litigation and patent expirations.
- Regulatory changes or drug shortages.
- Competitive innovations or combination therapies.
Strategic Market Entry & Opportunities
- Developing low-cost generics in emerging markets.
- Licensing opportunities for formulations with improved dosing.
- Expanding indications to adjunct therapies.
Summary
Entacapone (NDC 00046-1104) remains a vital drug for Parkinson’s management, with a market characterized by significant generic competition and price erosion. The shot-term outlook indicates continued price declines, reaching an estimated $300–$450 monthly by 2030, contingent on regulatory and market dynamics.
Key Takeaways
- The market is mature, with prices declining as generics dominate.
- The drug's importance in Parkinson's treatment sustains demand.
- Competitive pressures will likely depress prices over the next decade.
- Expansion into emerging markets offers growth potential.
- Monitoring patent status and new formulations remains essential.
FAQs
Q1: How does the patent status affect Entacapone pricing?
Patents expired in the early 2010s, enabling generic competition that lowers prices.
Q2: What are the main factors influencing market growth?
Increasing Parkinson’s prevalence and aging populations drive demand, countered by generic competition.
Q3: Are there dosage or formulation variations affecting pricing?
Yes. Fixed-dose combinations and extended-release formulations can influence costs.
Q4: What are the main competitive drugs?
Opicapone and Tolcapone are primary alternatives with differing safety profiles and pricing.
Q5: What are opportunities for new entrants?
Developing affordable biosimilars or combination therapies for Parkinson’s can expand market share.
References
[1] World Health Organization. (2022). Parkinson's Disease Fact Sheet. Retrieved from https://www.who.int/news-room/fact-sheets/detail/parkinson-s-disease
[2] Grand View Research. (2022). Parkinson’s Disease Treatment Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/industry-analysis/parkinsons-disease-treatment-market
