Last updated: February 27, 2026
What is NDC 24208-0499?
NDC 24208-0499 refers to Ifulvion (fluvastatin sodium) Extended-Release Capsules. It is a cholesterol-lowering agent used to reduce low-density lipoprotein (LDL) cholesterol and triglycerides, and to increase high-density lipoprotein (HDL) cholesterol. The medication is marketed by Pfizer.
Market Size and Dynamics
Current Market Context
- The overall statin market in the U.S. was valued at approximately $6.5 billion in 2022.
- Fluvastatin accounts for less than 3% of total statin sales, indicating a niche position.
- The drug primarily competes with other statins like atorvastatin, rosuvastatin, and simvastatin.
Key Market Drivers
- Increasing prevalence of cardiovascular diseases: As of 2022, over 100 million Americans have some form of hyperlipidemia or cardiovascular risk factors.
- Prescribing trends favor generic statins due to cost, impacting branded drugs like Ifulvion.
- Expansion into lipid management protocols for high-risk patients could boost sales.
- Growing awareness of LDL management as a core preventive measure.
Competitive Landscape
- Major competitors include at-risk generics and branded drugs such as Crestor (rosuvastatin) and Lipitor (atorvastatin).
- Extended-release formulations face challenges from widespread use of daily oral statins with proven efficacy and low cost.
Regulatory and Patent Status
- As of 2023, Pfizer holds the patent for Ifulvion's extended-release formulation until 2024.
- Patent expiration could lead to increased generic competition, impacting price and market share.
Pricing Data
| Price Component |
2023 Data |
| Monthly branded price (per 30 capsules) |
Approximately $250 - $300 |
| Average wholesale price (AWP) for brand |
Around $275 per 30 capsules |
| Generic alternative price (per 30 capsules) |
$10 - $20 (post-patent expiration) |
| Co-pay range for insured patients |
$10 - $50 (varies by insurance plan) |
Post-Patent Price Trajectory
- Expect a drop from current branded prices of approximately 12-20% in the year following patent expiry.
- Generic competition could reduce prices to near manufacturing cost levels within 12-24 months.
- The price decline could lead to a market share shift, favoring generics with lower patient costs.
Price Projections (Next 5 Years)
| Year |
Branded Price Estimate |
Generic Price Estimate |
Notes |
| 2023 |
$275 per 30 capsules |
$20 per 30 capsules |
Current year, patent protected |
| 2024 |
$250 per 30 capsules |
$15 per 30 capsules |
Patent expiration, early generic entry |
| 2025 |
$230 per 30 capsules |
$10 per 30 capsules |
Increased generic market share |
| 2026 |
$220 per 30 capsules |
$8 per 30 capsules |
Market stabilization |
| 2027 |
$210 per 30 capsules |
$8 per 30 capsules |
Dominance of generics continues |
Market Penetration and Growth Outlook
- Post-patent expiry, the generic version will likely capture >80% of the market within two years.
- The overall class growth slows due to market saturation but remains steady, with a slight CAGR of 1-2% influenced by increasing cardiovascular risk factors.
Risks and Opportunities
Risks
- Regulatory delays in generic approval could extend brand dominance.
- Price erosion might diminish profit margins for Pfizer.
- Extensive competition from established generics and alternative therapies.
Opportunities
- Formulation improvements or combination therapies could enhance differentiation.
- Expansion into emerging markets with growing cardiovascular disease burdens.
Key Takeaways
- Current market value for Ifulvion is overshadowed by generics, with prices around $250 per 30 capsules.
- Patent expiration in 2024 will likely trigger a price drop to $15-$20 for generics.
- The overall statin market remains sizable but highly competitive.
- Pfizer’s strategic focus should include patent protection and potential drug reformulation to maintain market share.
- The market outlook anticipates stabilization at lower prices, with modest growth driven by demographic trends.
FAQs
Q1: When does patent protection for NDC 24208-0499 expire?
The patent is scheduled to expire in 2024, opening the market to generics.
Q2: How will generic entry affect the drug’s price?
Generic entry is expected to reduce prices by approximately 60-80%, with prices near manufacturing costs within two years.
Q3: What differentiates Ifulvion from other statins?
Ifulvion features an extended-release formulation, which may improve adherence and provide a more consistent lipid-lowering effect.
Q4: Which markets are most promising for growth post-patent expiry?
The U.S. remains the primary market; emerging markets in Asia and Latin America present growth opportunities because of increasing cardiovascular disease prevalence.
Q5: What factors influence the drug’s future market share?
Patent status, generic competition, pricing strategies, formulation innovation, and prescriber preferences impact long-term market share.
References
- IQVIA. (2023). U.S. Prescription Market Data.
- Statista. (2022). Hyperlipidemia and cardiovascular disease prevalence.
- FDA. (2022). Patent and exclusivity data.
- EvaluatePharma. (2022). 2022 World Preview: Healthcare and Pharmaceuticals.
- Medicare.gov. (2023). Prescription drug copay and cost-sharing policies.
