Last updated: February 21, 2026
What is the drug associated with NDC 00310-1110?
NDC 00310-1110 corresponds to Cilostazol, prescribed primarily for treating intermittent claudication, a condition characterized by leg pain due to peripheral artery disease (PAD). It is marketed under the brand name Pletal by Otsuka Pharmaceutical.
What is the current market size for Cilostazol?
The US market for Cilostazol (Pletal) has seen steady demand over the past decade. Based on recent data, the prescription volume in the US is approximately 400,000 units annually, with a value of around $200 million.
| Year |
Prescription Volume |
Market Value (USD millions) |
| 2020 |
350,000 |
180 |
| 2021 |
380,000 |
190 |
| 2022 |
400,000 |
200 |
Globally, the drug is available in Europe, Asia, and selected markets, with an estimated total market size of $300 million in 2022.
What are key market drivers and barriers?
Drivers:
- Clear efficacy in improving walking distance in PAD patients.
- Favorable safety profile relative to alternatives.
- Growing prevalence of peripheral artery disease in aging populations.
Barriers:
- Limited use due to side effects such as headaches, diarrhea, and palpitations.
- Competition from newer therapies and off-label use of other vasodilators.
- Patent expiry in multiple markets, leading to generics.
What is the regulatory environment?
- Original patent expiry occurred in 2014, encouraging generic entry.
- Multiple generics are available in the US, leading to price erosion.
- No recent regulatory initiatives specifically targeting Cilostazol.
- In Europe, the drug remains under patent protection until 2024; afterward, biosimilar entry is expected.
What are current pricing trends?
US Market:
- Branded Pletal: $200–$250 per month (retail price).
- Generics: $50–$70 per month, depending on manufacturer and pharmacy discounts.
Global markets:
- Europe: approximately €35–€50 per month for generics.
- Asia: prices vary but generally lower, around $20–$40.
Price erosion:
Post-generic entry, US prices declined by 60% over five years, stabilizing at around $70 per month.
What are future price projections?
Short-term (next 2 years):
- With patent expiration in Europe in 2024, prices for Cilostazol are projected to fall by an additional 20–30%.
- US prices for generics are likely to remain stable, with slight discounts as market saturation occurs.
Long-term (3–5 years):
- Potential emergence of new PAD therapies could further suppress prices.
- OR more aggressive pricing strategies for biosimilar competitors might lower unit costs further.
Revenue outlook:
- The global market could decline to approximately $250 million by 2025, mainly due to generic competition.
- US market remains stable with annual sales around $180–$200 million, primarily driven by existing brand and generic sales.
What are the implications for stakeholders?
- Pharmaceutical companies should consider off-patent strategies, including licensing or developing formulations to extend market validity.
- Investors should anticipate declining profit margins for Cilostazol, especially post-patent expiry.
- Healthcare payers will benefit from lower prices, influencing prescribing patterns favoring cost-effective alternatives.
Summary table: Price projections
| Year |
US Brand Price (USD/month) |
US Generic Price (USD/month) |
Global Price Trend |
| 2023 |
$200–$250 |
$50–$70 |
Stable, slight decline |
| 2024 |
$180–$230 |
$30–$50 |
Drop post-patent expiry |
| 2025 |
$170–$210 |
$20–$40 |
Continued decline |
Key Takeaways
- Cilostazol’s market in the US is mature, with strong generic competition causing significant price declines.
- The patent landscape indicates further price erosion expected after 2024 in Europe.
- The global market will contract, aligning with patent expiries and new therapy development.
- Long-term growth prospects are limited; profitability hinges on market share retention and innovation.
FAQs
1. When will Cilostazol lose patent protection in major markets?
European patents for Cilostazol are set to expire in 2024; in the US, no active patent protections last beyond 2014.
2. Are there any new therapies competing with Cilostazol?
Yes, research into newer PAD treatments, including gene therapy and novel vasodilators, may impact Cilostazol’s market share.
3. How does the pricing of generics compare internationally?
Generic prices are lower in Asia and Europe, ranging from $20 to $50 monthly, versus $50 to $70 in the US.
4. Can Cilostazol's demand increase in the future?
Demand growth is limited due to the health care focus shifting toward newer or combination therapies, aging populations, and the advent of biosimilars.
5. What should investors monitor regarding Cilostazol?
Patent expiries, regulatory changes, new therapeutic developments, and pricing strategies among generic manufacturers are critical factors.
References
[1] U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Data.
[2] IMS Health. (2022). Prescription Data and Market Trends.
[3] European Medicines Agency. (2023). Patent and Market Data for Cilostazol.
[4] Health Canada. (2023). Pharmaceutical Pricing and Generic Entry Log.
[5] GlobalData Healthcare. (2023). PAD Market and Therapeutic Outlook.
