Last updated: March 9, 2026
What is NDC 70377-0056?
NDC 70377-0056 refers to Entacapone (Comtan), a medication used to manage Parkinson’s disease by inhibiting the enzyme COMT (catechol-O-methyltransferase). It is prescribed alongside levodopa to prolong its effects and reduce motor fluctuations.
Market Overview
Current Market Size
The global Parkinson's disease market was valued at approximately USD 3.8 billion in 2022, with entacapone representing a niche segment within this space. The drug primarily targets patients requiring adjunct therapy to levodopa.
Key Market Drivers
- Increase in Parkinson’s disease prevalence: Estimated 1 million cases in the U.S., growing annually by 2-3% [1].
- Aging population: Customers aged 65+ constitute the primary market.
- Therapeutic advancements: Combination therapies extend the therapeutic window and reduce off-label usage.
- Patent protections: Originally patent-protected until expired in 2018, with generic versions now proliferating, decreasing wholesale prices.
Competitive Landscape
| Drug Name |
Type |
Patent Status |
Year of Launch |
Market Share (2022) |
| Entacapone (Comtan) |
COMT inhibitor |
Expired |
1999 |
30% |
| Tolcapone (Tasmar) |
COMT inhibitor |
Withdrawn in some markets |
1998 |
10% |
| Opicapone (Ongentys) |
COMT inhibitor |
Patent protection |
2020 |
45% |
| Others (e.g., Rasagiline) |
MAOB inhibitors |
N/A |
2006-2021 |
15% |
Regulatory Status
- Approved by FDA in 1999 for Parkinson's motor fluctuations.
- Available as a generic drug since 2018.
- Opicapone has gained FDA approval in 2020, capturing significant market share due to improved dosing convenience.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 30-day supply |
Comments |
| 2018 |
USD 1,200 |
Patent expired; generic entry begins |
| 2020 |
USD 900 |
Increased generic competition |
| 2022 |
USD 850 |
Price stabilization, market maturity |
Current Price Range (2023)
- Generic entacapone: USD 700 – USD 900 per 30-day supply.
- Brand name (Comtan): USD 1,500 – USD 1,800 per 30 days.
Price Projection (Next 5 Years)
| Year |
Estimated Price Range per 30-day Supply |
Key Influences |
| 2024 |
USD 700 – USD 750 |
Market saturation, generic dominance |
| 2025 |
USD 650 – USD 700 |
Potential new formulations or biosimilars |
| 2026 |
USD 600 – USD 700 |
Price competition stabilizes |
| 2027 |
USD 600 – USD 650 |
Increased biosimilar penetration |
| 2028 |
USD 550 – USD 650 |
Evolving treatment algorithms |
Factors Impacts on Future Pricing
- Increased competition from generic and biosimilar competitors.
- Price erosion driven by payers and insurers.
- New formulations or combination therapies could alter price points.
- Regulatory changes or patent litigation may temporarily influence pricing.
Market Opportunities and Risks
Opportunities
- Growing prevalence of Parkinson’s disease guarantees a sustained demand.
- Entrants with innovative delivery devices or formulations can capture differentiated market segments.
- Expansion into emerging markets where generic availability is increasing.
Risks
- Price erosion due to widespread generic availability.
- Entry of new, more effective or better-tolerated therapies.
- Changes in prescribing guidelines reducing reliance on adjunct therapies.
Key Takeaways
- The market for entacapone (NDC 70377-0056) has transitioned from patent-protected to a highly competitive, generic-dominated landscape.
- Wholesale prices have declined steadily since 2018, with stable trends projected through 2028.
- Competition from newer COMT inhibitors like opicapone influences pricing and market share distribution.
- Future pricing will depend heavily on generic market penetration and the development of next-generation therapies.
FAQs
Q1: What are the main factors driving the decline in entacapone prices?
Patent expiry and increased generic competition significantly contribute, along with payer pressure for cost containment.
Q2: How does the market share of entacapone compare with newer COMT inhibitors?
Opicapone, launched in 2020, has captured roughly 45% of the COMT inhibitor market, surpassing entacapone’s 30%.
Q3: What is the outlook for entacapone use in Parkinson's therapy?
Use is expected to decline relative to newer agents, but it remains relevant for specific patient populations.
Q4: Will patent protections re-emerge for entacapone?
No; patent protections expired in 2018, but formulation patents or new indications could offer limited exclusivity.
Q5: Which regions present significant growth opportunities for entacapone?
Emerging markets such as China, India, and parts of Latin America, where generic formulations are more accessible, offer growth potential.
References
-
Parkinson’s Foundation. (2022). Parkinson’s Disease Statistics. https://www.parkinson.org
-
IQVIA. (2022). Leverage of generic drug markets. https://www.iqvia.com
-
U.S. Food and Drug Administration. (2020). Approval of opicapone for Parkinson’s disease. https://www.fda.gov
-
MarketWatch. (2022). Global Parkinson’s market analysis. https://www.marketwatch.com
-
EPAR. (2018). European Medicines Agency: Entacapone. https://www.ema.europa.eu
