Last updated: March 1, 2026
What is NDC 00591-3509?
NDC 00591-3509 identifies a specific drug. Based on available data, it corresponds to Ropinirole Hydrochloride tablets, used primarily for Parkinson’s disease and restless leg syndrome (RLS). The drug's label mentions dosages mainly at 0.25 mg, 1 mg, 2 mg, and 5 mg.
Market Landscape
Product Class and Competition
Ropinirole is a dopamine agonist. Major competitors include:
- Pramipexole (Mirapex)
- Rotigotine (Neupro)
- Apomorphine (Apokyn)
Market share favors Pramipexole slightly, with Ropinirole holding approximately 25-30% of the US RLS and Parkinson’s market, according to IQVIA data[1].
Market Size and Demand
In 2022, the U.S. market for dopamine agonists was valued at approximately USD 1.1 billion. The Ropinirole segment contributed around USD 300 million, with a projected compound annual growth rate (CAGR) of 4% through 2027[2].
Key Market Factors
- Increasing prevalence of Parkinson’s disease (estimated at 1 million cases in the US[3])
- Growing diagnosis rates of RLS
- Adoption of long-term pharmacological management
- Patent expirations affecting generics and biosimilars
Patent Status and Regulatory Environment
The original patent of Ropinirole expired in 2014. Multiple generics entered the market afterward, leading to price erosion. Recent regulatory actions by the FDA continue to shape entry barriers for new competitors in this space.
Price Analysis
Historical Pricing Trends
The wholesale acquisition cost (WAC) for Ropinirole has declined by approximately 40-50% since patent expiry. In 2014, the average WAC for a 30-day supply at 1 mg dosage was about USD 300. By 2022, this decreased to approximately USD 160.
Current Market Prices
| Dosage |
Average Wholesale Price (USD) |
2022 Data |
Source |
| 0.25 mg |
USD 55 per 30 tablets |
USD 55 |
[4] |
| 1 mg |
USD 160 per 30 tablets |
USD 160 |
[4] |
| 2 mg |
USD 250 per 30 tablets |
USD 250 |
[4] |
| 5 mg |
USD 350 per 30 tablets |
USD 350 |
[4] |
Note: Prices vary depending on the supplier, pharmacy, and geographic location.
Price Drivers for Future Projections
- Patent and exclusivity period impacts
- Number of generic manufacturers
- Regulatory changes incentivizing biosimilar entry
- Healthcare policies, including formulary preferences
- Production costs and supply chain factors
Price Projections (2023–2028)
Assumptions
- Continued generic competition maintains downward pressure
- No significant patent litigations or exclusivity extensions
- Market growth aligns with overall Parkinson’s and RLS prevalence trends
Forecast
| Year |
Projected Average Wholesale Price (USD) |
Notes |
| 2023 |
USD 150 - USD 180 |
Slight price stabilization as new generics enter |
| 2024 |
USD 140 - USD 170 |
Increased competition further reduces prices |
| 2025 |
USD 130 - USD 160 |
Mature generics market with stable pricing |
| 2026 |
USD 125 - USD 155 |
Potential for slight price increases if shortages occur |
| 2027 |
USD 120 - USD 150 |
Market reaches competitive equilibrium |
These projections reflect an approximate 10-15% decline over five years from current levels, with potential stabilization due to market saturation.
Key Market Trends
- Biosimilar and generic expansion will continue to suppress prices.
- Reimbursement policies may affect access and pricing dynamics.
- Emerging therapies, such as gene or cell therapies, could modify market growth.
Closing Summary
The market for Ropinirole (NDC 00591-3509) is characterized by significant price erosion stemming from generic competition. Prices are expected to stabilize slightly above current levels due to market saturation. The overall market remains sizable amid increasing prevalence rates, with continued growth driven by aging populations and disease awareness.
Key Takeaways
- Ropinirole remains a key treatment for Parkinson's and RLS, but face continuous generic competition.
- Prices declined about 50% since patent expiry, expected to stabilize within the next five years.
- The U.S. market size is approximately USD 300 million, with steady growth forecast.
- Prices will be influenced by regulatory actions, supply chain dynamics, and new therapeutic options.
- Investment and R&D decisions should consider patent landscapes, generic market penetration, and evolving healthcare policies.
Frequently Asked Questions
1. What are the main drivers influencing Ropinirole prices?
Generic competition, patent expiry, healthcare policies, and supply chain costs.
2. How does the competition from other dopamine agonists impact Ropinirole?
It puts downward pressure on prices and influences market share due to similar efficacy.
3. Are there upcoming regulatory changes expected to affect this market?
While no major patent litigation is scheduled, biosimilar and generics approvals regularly influence pricing.
4. What are emerging therapeutic alternatives that could replace Ropinirole?
Gene therapies and neurostimulation devices are under development but are not yet mainstream.
5. How should investors approach Ropinirole-related opportunities?
Focus on labeling, patent status of new formulations, and market share shifts among competitors.
References
[1] IQVIA. (2022). US Market Data on Dopamine Agonists.
[2] MarketLine. (2023). Parkinson’s Disease Drugs Report.
[3] Parkinson’s Foundation. (2022). Disease Statistics.
[4] Red Book. (2022). Wholesale Acquisition Cost Data.
