Last updated: March 28, 2026
What is the Drug Corresponding to NDC 43547-0442?
NDC 43547-0442 refers to Entacapone, marketed under the brand name Comtan. It is a medication used in combination with levodopa and carbidopa for Parkinson’s disease management. It functions as a catechol-O-methyltransferase (COMT) inhibitor, extending the effectiveness of levodopa.
Market Overview
Indication and Patient Population
- Primary use: Parkinson’s disease motor fluctuations.
- Target population: Approximately 1 million Parkinson's patients in the U.S. (2019 CDC estimates).
- Off-label uses: Not typical; primarily approved for PD.
Competitive Landscape
| Product Name |
Active Ingredient |
Market Share (2022) |
Notes |
| Comtan |
Entacapone |
45% |
First COMT inhibitor approved |
| Stalevo |
Levodopa + Carbidopa + Entacapone |
30% |
Fixed-dose combination including entacapone |
| Tolcapone |
Tolcapone |
15% |
Higher side-effect profile, less used |
| Others |
Various |
10% |
Developing COMT inhibitors |
Market Trends
- Growth Rate: Estimated at 4-6% annually (2022–2027).
- Drivers: Aging population, increase in Parkinson's diagnosis, improved awareness.
- Constraints: Pricing pressures, generic entry, side effect concerns.
Regulatory and Reimbursement
- FDA status: Approved since 1999.
- Reimbursement: Covered widely by Medicare and private insurers under Parkinson’s disease management protocols.
- Pricing controls: Managed by Medicare Part D formulary inclusion and negotiation.
Current Pricing Dynamics
Wholesale Acquisition Cost (WAC)
| Product |
2022 Price (per 30 days) |
2023 Price (per 30 days) |
Change |
Notes |
| Comtan |
$400 |
$380 |
-5% |
Slight reduction due to competition and generic options |
| Stalevo |
$500 |
$470 |
-6% |
Price declines associated with generics |
Retail Price Range
- Typical retail price: $450–$500 per 30-day supply for branded entacapone.
- Generic entacapone: Available since 2018, with prices approximately 20–30% lower.
Insurance Coverage & Out-of-Pocket Costs
- Patients with insurance pay copays averaging $10–$50.
- High out-of-pocket costs influence adherence and market penetration.
Price Projections (2023–2028)
| Year |
Projected WAC Price |
Key Assumptions |
Commentary |
| 2023 |
$370–$400 |
Continued generic competition suppresses prices |
Marginal decline due to multiple generic entries |
| 2024 |
$355–$380 |
Increased market share for generics |
Slight price stabilization |
| 2025 |
$340–$370 |
Patent exclusivity for branded product ends in 2024 |
Rise in generic market share, further price erosion |
| 2026 |
$330–$360 |
Margin compression expected |
Emerging biosimilar entrants for other PD meds |
| 2027 |
$320–$350 |
Market saturation; new formulations unlikely |
Stable or declining prices |
Factors Influencing Future Prices
- Patent expiration: Generic competition limits price increases post-2024.
- Market uptake: Increased adoption of fixed-dose combinations could shift pricing dynamics.
- Reimbursement policies: CMS and private payers may enforce stricter formulary controls.
- New entrants: Emerging drugs or biosimilars targeting PD could further suppress prices.
Key Market Drivers & Risks
-
Drivers:
- Growing Parkinson’s population.
- Demand for combination therapies.
- Cost constraints favoring generics.
-
Risks:
- Patent lapse leading to price erosion.
- Competition from emerging, potentially more effective therapies.
- Regulatory or reimbursement shifts impacting profitability.
Summary
| Aspect |
Details |
| Source of NDC |
Generic entacapone available since 2018 |
| Market size |
Approx. 1 million U.S. Parkinson’s patients |
| Competitive environment |
Dominant role of generics post-patent expiration |
| Pricing outlook |
Gradual decline due to generics; stabilized after 2025 |
Key Takeaways
- The primary product, entacapone (NDC 43547-0442), faces significant price pressure from generics since 2018.
- The 2023–2028 price outlook indicates gradual declines, with stabilization around 2025–2026.
- Market growth is driven mainly by demographic factors; pricing power diminishes with increased generic competition.
- Reimbursement frameworks impact patient out-of-pocket costs but generally support sustained market penetration.
- Future pricing depends on patent status, competition, and regulatory policies.
FAQs
Q1. When does patent exclusivity for the branded entacapone product end?
A1. The patent expired around 2018, allowing generics to enter the market.
Q2. How does generic competition influence pricing?
A2. It drives prices down, often by 20–30% compared to branded options.
Q3. Are there new drugs that could replace entacapone?
A3. Yes, several novel PD therapies are in development, potentially affecting the market share.
Q4. What are typical out-of-pocket costs for patients?
A4. Patients typically pay between $10 and $50 monthly under insurance plans.
Q5. How does the market outlook impact investment decisions?
A5. The declining price trend suggests limited upside for branded formulations beyond the next few years; generic market expansion reduces margins.
Citations
[1] CDC. (2019). Parkinson’s Disease Data.
[2] IQVIA. (2022). U.S. Prescription Drug Market Report.
[3] FDA. (1999). Approval History of Comtan.
[4] GoodRx. (2023). Entacapone Prices.
[5] Market Research Future. (2022). Parkinson’s Disease Market Analysis.
