Last updated: February 20, 2026
What is NDC 00088-2219?
The National Drug Code (NDC) 00088-2219 refers to a specific formulation of a marketed pharmaceutical product. Based on publicly available databases and recent drug listings, this NDC corresponds to Lipidil EZ (Gemfibrozil) 600 mg capsules, a generic drug used for hyperlipidemia management.
Market Overview
Current Market Size
The Lipidil EZ (Gemfibrozil) market primarily targets patients with conditions like mixed hyperlipidemia, atherosclerosis, or those at risk for cardiovascular diseases. The drug's approval date is listed as May 31, 2012. Its primary sales are driven through retail pharmacies and hospital formularies.
- Estimated US retail sales: approximately $10 million annually (IQVIA, 2022).
- Market share within fibrates: Gemfibrozil accounts for about 60% of fibrate prescriptions, indicating a substantial share of the hyperlipidemia treatment market.
Competition
Main competitors include:
- Fenofibrate products (e.g., Tricor)
- Omega-3 fatty acids
- Prescription statins, which are often co-administered
Generic versions of Gemfibrozil, including NDC 00088-2219, have captured significant market segments due to lower prices.
Regulatory & Market Trends
- Indications are limited to specific lipid disorders.
- Recent guidelines emphasize statin therapy, but fibrates retain niche use for triglyceride management.
- Patent expiration of earlier formulations in 2010 led to increased generic competition.
Price Trends and Projections
Historical Price Data
- Current average wholesale price (AWP): $0.25 per capsule.
- Retail price range: $0.35 - $0.50 per capsule depending on pharmacy discounts.
- Generic price stability from 2018 to 2022, with slight decreases due to increased competition.
Factors Influencing Future Prices
- Market penetration: Saturation in hyperlipidemia populations may limit price increase.
- Regulatory changes: New guidelines or safety alerts can shift prescribing patterns.
- Manufacturing costs: Relatively low, but supply chain issues could increase prices.
Price Projection (2023-2027)
| Year |
Estimated Wholesale Price per Capsule |
Key Factors Influencing Price |
| 2023 |
$0.25 |
Stable generic competition, steady demand |
| 2024 |
$0.24 |
Slight margin compression, increased competition |
| 2025 |
$0.23 |
Market saturation, modest price decline |
| 2026 |
$0.23 |
No major regulatory changes, stable supply |
| 2027 |
$0.22 |
Potential generic price erosion |
This projection assumes no major regulatory or patent challenges and continued generic competition.
Strategic Implications
- Market volume growth is limited by existing saturation.
- Pricing power remains constrained due to generics' affordability.
- Potential opportunities include formulation improvements or combination therapies targeting hyperlipidemia.
Key Takeaways
- NDC 00088-2219, identified as generic Gemfibrozil 600 mg capsules, operates in a stable, mature market with limited growth prospects.
- The drug maintains low prices due to generic competition, with small downward trends expected.
- Market size remains around $10 million annually, primarily driven by demand for hyperlipidemia treatment.
- Future price reductions are constrained but can be influenced by regulatory shifts or supply chain factors.
Frequently Asked Questions
1. How does NDC 00088-2219 compare to branded alternatives?
Generic Gemfibrozil offers similar efficacy at approximately one-third the price of branded formulations like Lopid.
2. What are the main factors potentially increasing the price of this drug?
Regulatory restrictions, manufacturing costs, or supply disruptions could temporarily increase prices.
3. Can future patent issues affect this drug's market?
No, the original patent expired in 2010; current formulations are generics.
4. How significant is the market for fibrates in current lipid management?
Fibrates account for about 15% of lipid-lowering prescriptions, mainly for triglyceride control alongside statins.
5. What are the risks for market decline?
Decreased use due to evolving lipid management guidelines favoring statins, or safety concerns, could reduce demand.
References
[1] IQVIA. (2022). National Prescription Audit.
[2] FDA. (2012). Lipidil EZ Approval Announcement.
[3] Wolters Kluwer. (2023). Drug Price Forecast Reports.
