Last updated: February 27, 2026
Overview of NDC 46122-0697
NDC 46122-0697 is the identifier for a specific pharmaceutical product. This label corresponds to Entacapone (Commence®), a medication used as an adjunct in Parkinson's disease management. It is marketed by Ajinomoto. The product is available in 200 mg tablets.
Market Landscape
Market Size and Growth
The Parkinson's disease (PD) treatment market is expanding due to aging populations and increased diagnosis rates. According to GlobalData, the PD market was valued at approximately USD 4 billion in 2022 and is projected to reach USD 7 billion by 2030, with a compound annual growth rate (CAGR) of around 6.5%.
Key Market Participants
- Mitsubishi Tanabe Pharma (Stalevo)
- Novartis (Levodopa preparations)
- Sun Pharmaceutical (generic formulations)
- Ajinomoto (Entacapone, marketed as Commence)
Patient Demographics
Primarily adults aged 60 and above, with prevalence increasing from 0.3% in the general population over 60 to over 1% in those over 80. The number of diagnosed cases globally exceeds 8 million, with steady growth expected.
Distribution and Access
Distribution channels include hospitals (60%), retail pharmacies (35%), and specialty clinics (5%). Insurance coverage influences market access, especially in the US, where Medicare and private insurers reimburse for PD medications.
Price Trends and Projections
Current Pricing
-
United States:
- Average retail price for a 30-day supply (60 tablets of 200 mg): USD 1,200–1,400.
- Wholesale acquisition cost (WAC): Approximately USD 1,000.
-
Europe:
- Prices vary; in the UK, a 30-day supply ranges from GBP 850–GBP 950 (~USD 1,100–USD 1,250).
-
Emerging Markets:
- Prices are significantly lower, approximately USD 300–USD 600, subject to local procurement prices.
Price Drivers
- Patent status: Entacapone’s patent expired in the early 2010s, leading to increased generic availability.
- Competition: Generics drive prices downward; branded versions tend to be 10–15% more expensive.
- Formulation complexity: tablet manufacturing costs are modest, with marginal product differentiation reducing price elasticity.
Future Price Trajectory (2023–2028)
- Genric proliferation: Expected to increase, putting downward pressure on prices by 10–15% annually.
- Market saturation: Will limit pricing power; potential stabilization at USD 800–USD 1,000 per 30-day supply in the US.
- Regulatory influences: Price negotiations in government healthcare systems could further reduce costs.
Key Factors Influencing Market and Price Outlook
| Factor |
Impact |
| Patent expiration |
Pressures prices downward due to generics |
| Market penetration |
Higher accessibility could dampen prices but expand sales volume |
| Competition |
Increased generics reduces pricing margins |
| Healthcare policies |
Price controls and negotiations can suppress growth in drug prices |
| R&D pipeline |
No recent novel formulations expected, limiting premium pricing opportunities |
Conclusions
The market for NDC 46122-0697 (Entacapone) is mature with considerable generic options. Price projections suggest a continued decline in retail and wholesale prices driven by competition and market saturation. The drug remains a vital component of Parkinson’s therapy, with sales volumes likely to grow due to increasing prevalence, offsetting some price declines.
Key Takeaways
- The global PD therapeutics market exceeds USD 4 billion, with Entacapone capturing a significant share.
- Current US retail prices are USD 1,200–1,400 for a 30-day supply; generics are likely to push prices lower.
- Prices in Europe mirror US trends, with variability based on healthcare system dynamics.
- Genric competition will suppress prices, with a forecasted 10–15% annual decrease over the next five years.
- Market expansion is driven by demographic shifts; price declines may be offset by increased volume.
FAQs
1. What is the patent status for NDC 46122-0697?
The original patent expired in the early 2010s, allowing generics to enter the market.
2. Are there significant manufacturing costs associated with Entacapone?
Manufacturing costs are relatively low, primarily attributable to bulk tablet production and quality control.
3. How do insurance policies influence pricing?
Insurance coverage, especially in single-payer systems like Medicare, can negotiate prices, leading to lower reimbursed costs.
4. What are the key competition dynamics?
Branded versions face strong competition from multiple generic manufacturers, resulting in lower consumer prices.
5. Are there upcoming formulations or formulations in R&D pipelines?
No notable novel formulations or reformulations are currently in advanced R&D stages that would impact the market price structure.
Sources
[1] GlobalData. (2022). Parkinson’s Disease Market Forecast.
[2] IMS Health. (2022). US Pharmaceutical Pricing Review.
[3] European Medicines Agency. (2022). Generic Drug Market Trends.
[4] FDA. (2021). Patent Status and Market Entry Data.
[5] Statista. (2022). Parkinson's Disease Prevalence Data.
