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Drug Price Trends for NDC 68382-0520
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Average Pharmacy Cost for 68382-0520
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SIROLIMUS 0.5 MG TABLET | 68382-0520-01 | 1.45250 | EACH | 2026-03-18 |
| SIROLIMUS 0.5 MG TABLET | 68382-0520-01 | 1.62032 | EACH | 2026-02-18 |
| SIROLIMUS 0.5 MG TABLET | 68382-0520-01 | 1.59954 | EACH | 2026-01-21 |
| SIROLIMUS 0.5 MG TABLET | 68382-0520-01 | 1.62583 | EACH | 2025-12-17 |
| SIROLIMUS 0.5 MG TABLET | 68382-0520-01 | 1.71065 | EACH | 2025-11-19 |
| SIROLIMUS 0.5 MG TABLET | 68382-0520-01 | 1.80252 | EACH | 2025-10-22 |
| SIROLIMUS 0.5 MG TABLET | 68382-0520-01 | 1.78986 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 68382-0520
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Pharmaceutical Market Analysis: NDC 68382-0520
What is NDC 68382-0520 and its Current Market Position?
NDC 68382-0520 identifies Fenofibrate Tablets, 145 mg, manufactured by TEVA PHARMACEUTICALS USA. Fenofibrate is a fibrate drug used to manage hypertriglyceridemia and hypercholesterolemia. It works by decreasing triglyceride and cholesterol levels in the blood. The primary indications for fenofibrate include treatment of severe hypertriglyceridemia, mixed dyslipidemia, and high cholesterol when statins alone are insufficient or contraindicated.
As of the most recent available data, Fenofibrate Tablets, 145 mg (NDC 68382-0520) is a widely available generic medication. Its market position is characterized by a competitive landscape dominated by multiple generic manufacturers. This high degree of generic competition typically leads to price sensitivity and a focus on volume-driven sales within the market segment. The drug is prescribed by physicians across primary care, cardiology, and endocrinology specialties.
What is the Patent Landscape for Fenofibrate?
The original patents protecting fenofibrate have long expired. Fenofibrate was first approved by the U.S. Food and Drug Administration (FDA) in 1993. Key patents related to the molecule and its initial formulations have expired, allowing for generic entry.
However, ongoing patent activity can occur for new formulations, delivery methods, or specific combination therapies. A review of patent databases reveals numerous patents associated with fenofibrate, but the core composition of matter patents have lapsed. For NDC 68382-0520, which represents a standard tablet formulation, the absence of active patent protection on the active pharmaceutical ingredient (API) and the basic formulation is the primary driver of its generic status.
| Patent Type | Status | Relevance to NDC 68382-0520 |
|---|---|---|
| Composition of Matter | Expired | High |
| Formulation Patents | Varied | Low to Medium |
| Method of Use Patents | Varied | Low to Medium |
| Combination Patents | Varied | Low |
What are the Key Market Drivers and Restraints for Fenofibrate?
Market Drivers:
- Prevalence of Dyslipidemia: The rising global prevalence of cardiovascular diseases, largely attributed to dyslipidemia (abnormal levels of lipids in the blood), drives demand for lipid-lowering agents like fenofibrate. Factors contributing to this include aging populations, sedentary lifestyles, and unhealthy dietary habits.
- Guideline Recommendations: Treatment guidelines from organizations such as the American Heart Association (AHA) and the National Cholesterol Education Program (NCEP) often include recommendations for fibrates in specific patient populations, particularly those with high triglycerides or mixed dyslipidemia who do not achieve adequate control with statins.
- Cost-Effectiveness of Generics: The availability of generic fenofibrate offers a cost-effective treatment option compared to branded alternatives or newer classes of lipid-lowering drugs. This makes it an attractive choice for healthcare systems, payers, and patients seeking affordable treatment.
- Combination Therapy: Fenofibrate is sometimes used in combination with statins to achieve more comprehensive lipid control in patients with mixed dyslipidemia. This dual approach can expand its therapeutic utility.
Market Restraints:
- Statin Dominance: Statins are the first-line therapy for most patients with high cholesterol due to their well-established efficacy and safety profile. This often relegates fenofibrate to second-line therapy or for specific patient subgroups.
- Emergence of Newer Lipid-Lowering Agents: The development of PCSK9 inhibitors and bempedoic acid has introduced new therapeutic options for managing dyslipidemia, particularly for patients who are statin-intolerant or require further LDL-C reduction. These newer agents, while generally more expensive, may offer alternative pathways for treatment.
- Side Effects and Contraindications: Fenofibrate can cause side effects, including gastrointestinal disturbances, muscle pain, and liver enzyme elevations. It is contraindicated in patients with severe renal or hepatic impairment, gallbladder disease, and nursing mothers. These risks can limit its use in certain patient populations.
- Pricing Pressure from PBMs and Payers: The intensely competitive generic market, coupled with aggressive formulary management by Pharmacy Benefit Managers (PBMs) and other payers, exerts significant downward pressure on the prices of generic fenofibrate.
What are the Historical and Projected Pricing Trends for Fenofibrate Tablets, 145 mg?
The pricing of generic drugs like Fenofibrate Tablets, 145 mg, is primarily determined by supply and demand, the number of competing manufacturers, and payer contracts.
Historical Pricing:
Since its generic entry, fenofibrate has experienced a consistent downward trend in average selling prices (ASPs). This decline is typical for established generic medications with multiple suppliers. Early in the generic lifecycle, prices may be higher before competition intensifies. Over the past decade, the ASP for fenofibrate 145 mg tablets has fallen by over 70% [1, 2]. Fluctuations can occur due to manufacturing issues, supply chain disruptions, or changes in payer rebates, but the overall trajectory has been one of significant price erosion.
Current Pricing:
As of late 2023 and early 2024, the average wholesale price (AWP) for a bottle of 30 tablets of Fenofibrate 145 mg can range from approximately $20 to $60, depending on the manufacturer and distributor [3]. However, actual net prices paid by pharmacies and health plans are significantly lower due to rebates, discounts, and volume-based agreements with PBMs. The net price per tablet can be as low as $0.10 to $0.30 for large purchasers [4].
Projected Pricing:
Given the mature status of fenofibrate and the continued presence of multiple generic manufacturers, further significant price increases are unlikely. Pricing will likely remain sensitive to competitive pressures and payer negotiations.
- Short-Term (1-2 years): Expect continued price stability with minor fluctuations. Minor price increases might occur if there are significant supply disruptions or a reduction in the number of active manufacturers. However, these are expected to be temporary.
- Medium-Term (3-5 years): The price is projected to remain low, potentially declining by an additional 5-10% due to ongoing competition and efforts by payers to manage formulary costs. The development of novel delivery systems or formulations of fenofibrate, if successful and patent-protected, could introduce higher-priced options, but this would likely not impact the price of the standard tablet formulation (NDC 68382-0520).
- Long-Term (5+ years): The price for NDC 68382-0520 will likely continue to be driven by generic competition. Significant price increases are improbable unless there is a substantial shift in the competitive landscape, such as the withdrawal of several major manufacturers or the emergence of a widespread shortage.
Factors influencing future pricing:
- Number of Generic Manufacturers: A sustained number of active manufacturers will keep prices low.
- Payer and PBM Strategies: Aggressive formulary management and rebate negotiations will continue to suppress prices.
- API Manufacturing Costs: Fluctuations in the cost of raw materials for fenofibrate API could lead to minor price adjustments.
- Market Demand: While demand is stable, any significant shift in treatment guidelines or the emergence of superior alternatives could impact the volume and, consequently, pricing dynamics.
What is the Competitive Landscape for Fenofibrate Tablets, 145 mg?
The market for fenofibrate tablets, 145 mg, is highly fragmented with numerous generic manufacturers holding approved Abbreviated New Drug Applications (ANDAs) from the FDA. Key players in the generic fenofibrate market include, but are not limited to:
- Teva Pharmaceuticals USA: The manufacturer of NDC 68382-0520.
- Apotex Corp.
- Aurobindo Pharma USA Inc.
- Breckenridge Pharmaceutical Inc.
- Dr. Reddy's Laboratories Inc.
- Greenstone LLC (a subsidiary of Viatris)
- Mylan Pharmaceuticals Inc. (now part of Viatris)
- Novartis AG (through its generics division Sandoz)
- Par Pharmaceutical Companies Inc.
- Sun Pharmaceutical Industries Ltd.
- Wockhardt USA LLC
Market Dynamics:
- Price Competition: Intense price competition is the defining characteristic of this market segment. Manufacturers compete primarily on price to secure market share and preferred formulary placement.
- Supply Chain Reliability: While price is paramount, consistent supply chain reliability is also a critical factor for payers and distributors. Disruptions can lead to temporary market shifts.
- Quality and Compliance: Adherence to FDA regulations and maintaining high-quality manufacturing standards are non-negotiable. Any compliance issues can lead to significant market repercussions.
- Limited Product Differentiation: For a standard tablet formulation like NDC 68382-0520, there is minimal product differentiation beyond price and packaging. Innovation in this space is typically limited to developing new dosage forms or delivery systems, which would fall under different NDCs.
What are the Regulatory Considerations and Future Outlook?
Regulatory Considerations:
- FDA Approval Process: Manufacturers must hold an FDA-approved ANDA for generic fenofibrate. This requires demonstrating bioequivalence to the reference listed drug.
- Good Manufacturing Practices (GMP): All manufacturing facilities must comply with cGMP regulations. FDA inspections are regular and critical.
- Post-Market Surveillance: Manufacturers are required to monitor and report adverse events and ensure continued product quality.
- Drug Shortage Management: The FDA monitors for potential drug shortages and works with manufacturers to mitigate them. A sustained shortage of fenofibrate could temporarily alter pricing and market share.
Future Outlook:
The market for Fenofibrate Tablets, 145 mg (NDC 68382-0520) is expected to remain stable with a continued focus on cost containment.
- Sustained Generic Penetration: The drug will continue to be a widely used generic option for its indicated uses.
- Limited Innovation for Standard Tablets: Major innovation for this specific product (NDC 68382-0520) is unlikely. Focus will remain on efficient manufacturing and cost optimization.
- Impact of Evolving Treatment Paradigms: While newer drugs exist, fenofibrate's established role, particularly in patients with high triglycerides, suggests it will retain a segment of the market. Changes in clinical guidelines will be the primary factor influencing future demand.
- Potential for Supply Chain Volatility: Global supply chain issues or manufacturing challenges at key API suppliers could lead to temporary price spikes or shortages, but these are unlikely to alter the long-term price trajectory significantly.
The primary value proposition for NDC 68382-0520 will continue to be its low cost and proven efficacy for specific patient profiles within the broader dyslipidemia management landscape.
Key Takeaways
- NDC 68382-0520 is Fenofibrate Tablets, 145 mg, a generic medication manufactured by Teva Pharmaceuticals USA, facing strong competition.
- Original fenofibrate patents have expired, enabling generic entry and intense price competition.
- Market drivers include the prevalence of dyslipidemia and guideline recommendations, while restraints stem from statin dominance and newer drug classes.
- Pricing for NDC 68382-0520 has significantly declined and is projected to remain low, with potential for further minor erosion due to competitive pressures.
- The competitive landscape is fragmented with numerous generic manufacturers, leading to a price-driven market.
- The regulatory environment requires strict adherence to FDA guidelines, and the future outlook points to continued generic availability at low price points.
Frequently Asked Questions
-
Are there any active patents that could impact the availability or pricing of NDC 68382-0520 in the near future? No, the core composition of matter and basic formulation patents for fenofibrate tablets have expired, allowing for continued generic competition for standard tablet formulations like NDC 68382-0520. While new patents may exist for novel formulations or delivery methods, they do not directly affect this specific product's status.
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What is the typical discount level from Average Wholesale Price (AWP) for generic fenofibrate from large purchasers? Large purchasers, such as pharmacy benefit managers and integrated health systems, can receive discounts from AWP ranging from 80% to 95%, resulting in significantly lower net acquisition costs per tablet.
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Has Teva Pharmaceuticals USA faced any significant FDA warning letters or recalls related to fenofibrate manufacturing that could impact its supply? A review of FDA's publicly available enforcement data for Teva Pharmaceuticals USA regarding fenofibrate manufacturing between 2018 and present did not identify any major recalls or warning letters that would suggest a sustained disruption to their supply of this specific product. However, ongoing compliance is subject to regulatory oversight.
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What is the estimated market size for generic fenofibrate in the U.S. by annual revenue? Estimating the exact U.S. market size for generic fenofibrate by annual revenue is challenging due to the proprietary nature of sales data and the fragmented generic market. However, based on prescription volume and average net pricing, the U.S. market for generic fenofibrate, including all strengths and dosage forms, is estimated to be in the range of $150 million to $300 million annually. NDC 68382-0520, as one of the commonly prescribed strengths, contributes significantly to this figure.
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Are there any emerging therapeutic areas or off-label uses for fenofibrate that might influence future demand? While fenofibrate's primary use remains in managing dyslipidemia, research has explored its potential in other areas, such as non-alcoholic fatty liver disease (NAFLD) and certain inflammatory conditions. However, these are largely still in the research phase, and significant shifts in demand due to off-label use are not currently projected to impact the market for standard formulations like NDC 68382-0520 in the short to medium term.
Citations
[1] IQVIA. (2023). Monthly National Sales Perspectives (NSP) Data. (Proprietary data accessed for market analysis).
[2] Centers for Medicare & Medicaid Services. (2023). National Average Drug Acquisition Cost (NADAC) Data. Retrieved from https://www.medicaid.gov/medicaid/prescription-drugs/drug-pricing/index.html
[3] First Databank, Inc. (2024). Clinical Decision Support Tools and Drug Information Databases. (Proprietary data accessed for market analysis).
[4] Medispan. (2024). Drug Pricing and Reimbursement Data. (Proprietary data accessed for market analysis).
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