Last updated: February 23, 2026
What is NDC 00143-9595?
NDC 00143-9595 refers to Entacapone, a drug used in the management of Parkinson’s disease. It functions as a COMT inhibitor, extending the effect of levodopa by preventing its breakdown.
Market Size and Growth
Current Market Size
- The global Parkinson’s disease therapeutics market was valued at approximately $4.3 billion in 2022.
- Entacapone accounts for roughly 15-20% of the COMT inhibitor segment, estimated at $800 million to $1 billion.
- The drug's market share is primarily concentrated in North America and Europe, with increasing penetration in Asia-Pacific.
Growth Drivers
- Rising prevalence of Parkinson’s disease: Estimated at 10 million cases worldwide and growing annually at 4%.
- Increased adoption of combination therapy: Entacapone is often used with levodopa.
- Patent expirations and generic entry: May influence pricing and market share.
Competitive Landscape
- Main competitors include Tolcapone (Tasmar) and Opicapone (Ongentys).
- Opicapone has gained FDA approval in 2020, capturing a significant portion of market share due to improved safety profile and dosing convenience.
Price Trends
Current Pricing Dynamics
| Product |
Average Wholesale Price (AWP) |
Estimated Patient Out-of-Pocket Price |
Marketed Forms |
| Brand (Comtan) |
~$350 per 200 mg tablet |
~$30 per tablet |
Oral tablets, 200 mg dosage |
| Generics |
~$150–220 per 200 mg tablet |
~$10–$20 per tablet |
Multiple manufacturers, biosimilar |
- In 2022, brand price has declined approximately 10-15% due to increasing generic availability.
- Patient out-of-pocket varies based on insurance, with high deductibles driving reliance on generics.
Price Projections (Next 5 Years)
| Year |
Estimated Wholesale Price for 200 mg |
Key Assumptions |
Notes |
| 2023 |
~$150 |
Continued generic competition; stable demand |
Reduced from peak brand pricing (~$350) |
| 2024 |
~$130 |
Increased generic market penetration |
Possible biosimilar competition emerges |
| 2025 |
~$100 |
Patent expirations; biosimilars gain market share |
Regulatory approvals for biosimilars expected in this period |
| 2026 |
~$80–90 |
Consolidation of biosulis; demand stabilizes |
Price reduction driven by economies of scale and market saturation |
| 2027 |
~$70–80 |
Widespread biosimilar use; insurance negotiations |
Pricing normalizes to generic levels |
Influencing Factors
- Patent cliffs: The patent for Comtan expired in 2019; generic competition has since increased.
- Regulatory actions: Fast-track approval of biosimilars could accelerate price declines.
- Healthcare policies: Cost containment efforts may pressure drug prices further.
- Market penetration of alternatives: Opicapone has shown competitive advantages, impacting Entacapone’s market share and prices.
Regulatory and Patent Status
- Patent status: The original patent for Entacapone expired in 2019.
- Generic availability: Multiple manufacturers produce generics; market share increases.
- Biosimilar prospects: No biosimilar approved yet, but possible future entries.
Investment and R&D Outlook
- R&D efforts focus on longer-acting formulations of COMT inhibitors and combination therapies.
- Market shifts favor drugs with better safety profiles and adherence features.
- The rise of personalized medicine could influence future demand.
Key Takeaways
- Market size for Entacapone remains significant within Parkinson’s therapeutics, approximately $800 million to $1 billion.
- The drug’s price has declined markedly due to generic competition, dropping from $350 to around $150 per 200 mg tablet.
- Projected prices will decrease further, potentially reaching $70–80 by 2027 due to biosimilar and generic proliferation.
- Competitive pressures from Opicapone and other therapies impact market share and pricing strategies.
- Regulatory developments and healthcare policy shifts will influence future market dynamics.
Frequently Asked Questions
1. What are the primary factors driving the decline in Entacapone prices?
Generic competition, patent expiration, and biosimilar development pressure lead to price declines. Insurance and reimbursement policies also influence retail prices.
2. How does Entacapone compare with newer COMT inhibitors?
Opicapone is a once-daily formulation with a better safety profile. It is gaining market share, which impacts Entacapone's pricing and volume.
3. What is the outlook for Entacapone's market share?
Market share is expected to decrease gradually with biosimilar entries and newer drugs offering improved safety and efficacy profiles.
4. How susceptible is the market to regulatory changes?
Regulatory actions that expedite biosimilar approvals or impose price controls can significantly impact market dynamics and pricing.
5. What are potential opportunities for investment in the Parkinson’s therapy space?
Investments in biosimilars, novel COMT inhibitors, and combination therapy formulations represent growth opportunities, especially as competition increases.
References
[1] MarketWatch. (2023). Parkinson’s Disease Drugs Market Size & Trends.
[2] IQVIA. (2022). Global Pharma Market Insights.
[3] US Food and Drug Administration. (2020). FDA Approves Opicapone for Parkinson’s Disease.
[4] STAT. (2022). Biosimilars gain traction in neurodegenerative disorders.
[5] National Institute of Neurological Disorders and Stroke. (2022). Parkinson’s Disease Fact Sheet.
