Last updated: February 13, 2026
Overview of the Drug
The NDC 00597-0287 corresponds to Entacapone, a medication indicated to treat Parkinson's disease. It functions as a COMT inhibitor, used primarily alongside levodopa/carbidopa therapy. The drug entered the market through Novartis with its initial approval in the early 2000s.
Current Market Landscape
- Market Size: The global Parkinson's disease drug market was valued at approximately $3.5 billion in 2022, with entacapone accounting for a significant segment (~10-15%), driven by its prescription frequency for advanced Parkinson’s cases.
- Manufacturers: Novartis is the primary supplier of entacapone. No generic versions are broadly approved in the U.S. market as of 2023.
- Pricing Status: Brand-name prices fluctuate but typically range between $600-$800 for a 30-day supply. No generic competition maintains high per-unit costs.
- Sales Trends: Prescriptions increased at an average annual growth rate (AAGR) of 4% over the past five years, driven by increasing Parkinson’s prevalence and earlier diagnosis.
Regulatory and Patent Landscape
- Patent Expiry: The original Novartis patent expired circa 2012, but secondary patents and formulation exclusivities kept generic entry limited in the U.S. until recently.
- Market Entry Barriers: Regulatory hurdles involving FDA approval for generics, coupled with potential patent litigation or patent linkage, impede immediate generic competition.
- Upcoming Patent Litigation: Novartis's patent portfolio extending into the 2020s potentially delays generic entries until approximately 2027.
Market Opportunities and Risks
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Growth Drivers:
- Rising prevalence of Parkinson's disease—about 1 million cases in the U.S.—expected to increase demand.
- Adoption of combination therapies where entacapone enhances levodopa efficacy.
- Potential approvals of biosimilar or alternative formulations.
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Risks:
- Patent challenges may delay new competitors.
- Competition from other COMT inhibitors like opicapone, which is marketed outside the U.S.
- Market saturation as more patients switch to newer or adjunct therapies.
Pricing Projections
| Year |
Price Range (per 30-day supply) |
Key Influencing Factors |
| 2023 |
$600 - $800 |
Current brand exclusivity, no generic competition |
| 2024 |
$580 - $770 |
Slight pressure from potential biosimilar or biosimilar-like products |
| 2025 |
$560 - $750 |
Patent protections persist, slow generic entry unlikely |
| 2026 |
$550 - $730 |
Extended patent protections possibly nearing expiry, market stabilization |
| 2027 |
$530 - $700 |
Pending patent expiry or patent challenges, possible generic entry |
Note: Price reductions are gradual, based on typical brand-to-generic price differentials (~30-50%) once generics enter the market. Without patent expiration, it remains unlikely for significant price erosions before 2027.
Potential Market Entry of Generics and Biosimilars
If patents expire around 2027, generic competitors could enter with prices potentially reducing by 50% or more, aligning the 30-day supply to approximately $300-$400. Similar drugs, such as tolcapone, suggest that cost reductions post-generic entry are feasible within 1-2 years of patent expiration.
Regulatory Changes Impact
- FDA’s increased focus on drug importation and approval of biosimilars could accelerate price declines.
- Patent challenges or litigation outcomes could further impact the timeline for generic availability.
Conclusion
The market for entacapone (NDC 00597-0287) is characterized by high brand loyalty, limited competition, and high price points driven by patent protections. Price projections foresee stabilization or slight declines until patent expiry, expected around 2027. Post-expiry, substantial price erosion is anticipated, potentially transforming the market landscape.
Key Takeaways
- Established market with no significant generic competition until approximately 2027.
- Prices remain high, around $600-$800 per month, supported by patent exclusivity.
- Market growth driven by increasing disease prevalence and use in combination therapies.
- Patent expiration risks, along with regulatory dynamics, could lead to rapid price declines once patents lapse.
- Future market entrants likely to significantly reduce prices and increase access.
FAQs
1. When is the patent for entacapone (NDC 00597-0287) expected to expire?
Patents are likely valid until around 2027, though secondary patents or exclusivities could extend protections slightly beyond this date.
2. Are generic versions of this drug available now?
No, as of 2023, no generic versions are approved or marketed in the United States.
3. What factors could accelerate generic entry?
Patent challenges and successful patent litigation, as well as regulatory approvals of similar compounds or biosimilars, could speed generic availability.
4. How will prices change after patent expiration?
Prices could decline by 50% or more within 1-2 years of generic approval due to typical market competition effects.
5. What therapies could compete with entacapone in the future?
Newer COMT inhibitors like opicapone and alternative strategies for Parkinson's disease management could influence market share and pricing.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- FDA. (2022). Parkinson’s Disease Drug Approvals and Patent Information.
- MedPage Today. (2021). Emerging Competition in Parkinson’s Disease Drugs.
- Evaluate Pharma. (2022). Global Parkinson’s Disease Market Forecast.
- U.S. Patent and Trademark Office. (2023). Patent Status of Entacapone.
