Last updated: March 1, 2026
What is NDC 00009-3475?
NDC 00009-3475 corresponds to Entacapone/Carbidopa/Levodopa tablets. It is an adjunct therapy used in Parkinson’s disease to enhance motor control when levodopa alone becomes less effective.
Market Overview
Market Size and Demand
The Parkinson’s disease treatment market was valued at approximately $8.2 billion in 2021 (MarketWatch, 2022). The therapy involving entacapone accounts for roughly 12% of this market, equating to an estimated $985 million annually in the U.S. alone.
Key Competitors
- Stalevo: Combination of entacapone, carbidopa, and levodopa, produced by Boehringer Ingelheim.
- Other brands: COMT inhibitors as monotherapy or in combination with other Parkinson’s drugs.
Prescription Trends
Prescription volume for entacapone has exhibited stable growth, approximately 3-5% annually over the past three years (IQVIA, 2022). Favorable safety profiles are driving sustained demand amid growing Parkinson’s prevalence, which is projected to reach 12 million globally by 2040 (WHO, 2022).
Regulatory Landscape
The drug is approved by FDA since 1999. Patent status is expired or near expiry, with generics already entering the market. This impacts pricing, as brand-name premiums diminish.
Pricing Analysis
Current Price Points
- Brand name (Stalevo): Average wholesale price (AWP) ranges from $8.50 to $10.50 per tablet.
- Generic entacapone: Similar AWP, roughly $8.00 to $9.50 per tablet.
Factors Influencing Price
- Market saturation: Entry of generics drives prices down.
- Reimbursement policies: CMS and private insurers favor generics, limiting premium pricing.
- Manufacturing costs: Stable with scale, marginally influencing retail prices.
Price Projections (Next 3 Years)
| Year |
Estimated Price per Tablet |
Assumptions |
| 2023 |
$7.50 - $8.50 |
Generic market stabilizes; slight price compression |
| 2024 |
$7.00 - $8.00 |
Increased generic competition; price erosion begins |
| 2025 |
$6.50 - $7.50 |
Market matures; price plateau without innovation |
Revenue Implications
Given consistent prescription growth, the revenue from NDC 00009-3475 is forecasted to decrease modestly due to price erosion, despite increasing volume.
Key Market Drivers and Risks
- Drivers: Growing Parkinson’s prevalence, increased acceptance of combination therapies, stable demand for adjunct medications.
- Risks: Patent expiry, entry of alternative drugs like dopamine agonists, and biosimilars, leading to further price declines.
Strategic Considerations
- Brand differentiation: Focus on formulation improvements or extended-release versions.
- Pricing strategies: Emphasize value through improved efficacy or reduced side effects.
- Market expansion: Explore emerging markets with rising healthcare infrastructure and Parkinson’s burden.
Conclusion
The market for NDC 00009-3475 will remain stable but faces downward pressure on prices owing to generic competition. Revenue forecasts suggest slight declines in per-unit pricing over the next three years with sustained demand driven by demographic trends. Companies should focus on product differentiation and market expansion to mitigate price erosion.
Key Takeaways
- The U.S. market value for entacapone combinations approximates $985 million annually.
- Wholesale prices are declining, with a projected drop to below $7 per tablet by 2025.
- Prescription volume is expected to grow at 3-5% annually, offsetting some price declines.
- Patent expiry and generic entry are primary factors influencing future pricing.
- Strategic growth relies on expanding into emerging markets and product innovation.
FAQs
What factors most significantly influence entacapone pricing?
Market competition from generics, prescription volumes, reimbursement policies, and manufacturing costs.
Are there upcoming patent protections that could stabilize prices?
No, patent expiration has occurred or is imminent, with generic options dominating.
What is the future outlook for Parkinson’s drug market growth?
Stable demand with a compound annual growth rate (CAGR) of approximately 3-4% driven by aging demographics.
How do biosimilars impact this market?
While biosimilars are less relevant for small-molecule drugs like entacapone, similar generic strategies will push prices downward.
What strategies can manufacturers adopt to sustain revenue?
Product differentiation through formulations, geographic expansion, and value-based pricing.
References
- MarketWatch. (2022). Parkinson’s Disease Drugs Market Size. [Online] Available at: https://www.marketwatch.com/
- IQVIA. (2022). Prescription Trends Report. [Online]
- World Health Organization. (2022). Parkinson's Disease Fact Sheet. [Online] Available at: https://www.who.int/
