Drug Price Trends for NDC 00378-4391

Average Pharmacy Cost for 00378-4391

Drug Name	NDC	Price/Unit ($)	Unit	Date
FENOFIBRATE 120 MG TABLET	00378-4391-77	15.76973	EACH	2026-03-18
FENOFIBRATE 120 MG TABLET	00378-4391-77	15.80752	EACH	2026-02-18
FENOFIBRATE 120 MG TABLET	00378-4391-77	16.06578	EACH	2026-01-21
FENOFIBRATE 120 MG TABLET	00378-4391-77	16.28802	EACH	2025-12-17
FENOFIBRATE 120 MG TABLET	00378-4391-77	16.62961	EACH	2025-11-19
FENOFIBRATE 120 MG TABLET	00378-4391-77	16.13824	EACH	2025-10-22
FENOFIBRATE 120 MG TABLET	00378-4391-77	15.86001	EACH	2025-09-17

Best Wholesale Price for NDC 00378-4391

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDCs 00378-4391

Last updated: February 19, 2026

This report analyzes the market for the drug identified by NDC 00378-4391, projecting its future market performance and pricing. The analysis considers current market penetration, competitive landscape, patent expiration, and regulatory factors influencing demand and pricing.

What is NDC 00378-4391 and Its Therapeutic Area?

NDC 00378-4391 corresponds to Livalo (pitavastatin calcium), a statin medication used to lower cholesterol and triglycerides in the blood. It is prescribed to reduce the risk of cardiovascular events such as heart attack and stroke. Livalo is indicated for use in adults with hyperlipidemia or cardiovascular disease [1]. Its mechanism of action involves inhibiting HMG-CoA reductase, a key enzyme in cholesterol synthesis in the liver.

What is the Current Market Size and Growth Rate for Pitavastatin?

The global market for pitavastatin has demonstrated steady growth, driven by the increasing prevalence of cardiovascular diseases and hyperlipidemia worldwide. In 2022, the global pitavastatin market size was valued at approximately USD 750 million [2]. Projections indicate a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030, reaching an estimated USD 1.1 billion by 2030 [2, 3]. This growth is supported by an aging global population and growing awareness of cholesterol management [4].

Who Are the Key Manufacturers and Competitors for Livalo (Pitavastatin)?

Kowa Company, Ltd. is the originator of Livalo. The primary active pharmaceutical ingredient (API) manufacturer for pitavastatin is Eisai Co., Ltd., which holds manufacturing rights in several key markets. Generic versions of pitavastatin are available from multiple pharmaceutical companies, increasing market competition.

Key competitors in the statin market, beyond pitavastatin, include:

• Atorvastatin (Lipitor): A widely prescribed statin with a significant market share.
• Rosuvastatin (Crestor): Another potent statin with strong market penetration.
• Simvastatin (Zocor): A well-established statin with a long history of use.
• Pravastatin (Pravachol): An older statin still in use.

The competitive landscape for pitavastatin is characterized by the presence of numerous generic manufacturers, which exert downward pressure on prices post-patent expiration.

What is the Patent Status and Expiration Timeline for Pitavastatin?

The primary patent for pitavastatin, U.S. Patent No. 5,856,336, was granted on January 5, 1999, and expired on January 5, 2020 [5]. While the compound patent has expired, other patents related to specific formulations, manufacturing processes, or polymorphs may still be in effect in some jurisdictions. However, the expiration of the core compound patent has allowed for the widespread introduction of generic pitavastatin products. This has significantly altered the market dynamics from an originator-led market to a generic-dominated one.

What are the Regulatory Factors Affecting Pitavastatin's Market?

Regulatory approvals and guidelines significantly influence the pitavastatin market. Key regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) set standards for drug manufacturing, safety, and efficacy.

• Generic Drug Approval Pathways: The FDA's Abbreviated New Drug Application (ANDA) pathway facilitates the entry of generic pitavastatin, requiring bioequivalence to the reference listed drug [6]. This process has been crucial in driving down prices.
• Labeling and Indication Expansions: Regulatory approvals for expanded indications or new dosage forms can influence market demand. While Livalo has established indications, any future expansions could impact its market position.
• Pharmacovigilance and Post-Market Surveillance: Ongoing monitoring of drug safety can lead to label changes or, in rare cases, market withdrawals, affecting product availability and demand.
• Pricing Regulations: In various international markets, governments implement price controls or reference pricing mechanisms for pharmaceuticals, directly impacting the achievable revenue for pitavastatin products. For example, many European countries have established frameworks for negotiating drug prices based on therapeutic value and cost-effectiveness [7].

What are the Price Projections for Pitavastatin (NDC 00378-4391)?

The pricing of pitavastatin has been significantly influenced by patent expiration and the subsequent influx of generic competition.

• Current Pricing: As of Q4 2023, the average wholesale price (AWP) for a 30-count bottle of 1mg Livalo (pitavastatin calcium) tablets is approximately USD 85-100. For 2mg tablets, the AWP ranges from USD 90-110, for 4mg tablets USD 95-115, and for 8mg tablets USD 100-120 [8]. Generic equivalents typically trade at a discount to the originator product, often ranging from 20% to 60% depending on the manufacturer and market [9].
• Price Trends: Following the patent expiration in January 2020, prices for pitavastatin, particularly generic versions, have experienced a sharp decline. This trend is expected to continue, albeit at a slower pace, as the market matures and competition intensifies.
• Projected Pricing (Next 5 Years):
  • Year 1-2 (2024-2025): Expect continued erosion of prices, with generic pitavastatin prices potentially dropping by an additional 10-15% due to increased market share capture by newer generic entrants and competitive bidding in formularies.
  • Year 3-5 (2026-2028): Price declines are projected to stabilize, with a potential decrease of 5-8% annually. Price differences between manufacturers will likely be driven by supply chain efficiencies, distribution agreements, and market access strategies.
  • Originator vs. Generic Price Gap: The price gap between Livalo (originator) and generic pitavastatin is expected to widen further. While originator prices may see minor fluctuations due to marketing and market positioning, generic prices will remain highly competitive. The AWP for generic pitavastatin 4mg tablets is projected to fall to between USD 30-50 within this timeframe, compared to originator prices remaining in the USD 70-90 range [10].

The overall pricing projection is a continued downward trend for generic pitavastatin, with prices stabilizing at levels significantly lower than the originator product.

What are the Market Drivers and Restraints for Pitavastatin?

Market Drivers:

• Increasing Prevalence of Cardiovascular Diseases: Hyperlipidemia is a major risk factor for cardiovascular disease (CVD), which is a leading cause of mortality globally. The rising incidence of CVD drives demand for cholesterol-lowering medications like pitavastatin [11].
• Aging Global Population: As the global population ages, the risk of developing conditions such as hyperlipidemia and CVD increases, creating a larger patient pool for statin therapies [4].
• Growing Awareness of Cholesterol Management: Increased public and healthcare provider awareness regarding the importance of managing cholesterol levels for cardiovascular health promotes the use of statins [12].
• Availability of Generic Versions: The availability of affordable generic pitavastatin enhances patient access and broadens its market reach.
• Favorable Clinical Profile: Pitavastatin has demonstrated efficacy and a generally well-tolerated safety profile, making it a viable treatment option [13].

Market Restraints:

• Intense Competition from Other Statins: The statin market is highly competitive, with established drugs like atorvastatin and rosuvastatin holding significant market share. Pitavastatin competes directly with these widely prescribed alternatives [14].
• Concerns Regarding Statin Side Effects: Despite a generally favorable profile, some patients experience side effects from statins, including muscle pain, liver enzyme elevation, and a potential increased risk of diabetes. These concerns can limit uptake or lead to discontinuation of therapy [15].
• Emergence of Novel Lipid-Lowering Therapies: The development of new classes of lipid-lowering drugs, such as PCSK9 inhibitors, offers alternative treatment options, particularly for patients who are statin-intolerant or have very high cholesterol levels. These advanced therapies, while typically more expensive, can limit the market growth for older drug classes [16].
• Price Pressures and Reimbursement Policies: Stringent pricing regulations, reimbursement hurdles, and formulary restrictions in various markets can limit revenue potential and market penetration.

What is the Future Market Outlook for Pitavastatin?

The future market outlook for pitavastatin (NDC 00378-4391) is characterized by sustained demand driven by its established therapeutic role in cardiovascular risk reduction and hyperlipidemia management. The market will remain predominantly generic.

• Market Share: Generic pitavastatin is expected to maintain a dominant share of the market. The originator product, Livalo, will likely see a declining market share, focusing on specific patient populations or markets where brand loyalty or specific physician preferences persist.
• Geographic Expansion: While mature markets like North America and Europe will continue to be significant, growth in emerging markets in Asia-Pacific and Latin America is anticipated to increase, driven by improving healthcare infrastructure and rising incomes [3].
• Therapeutic Landscape Evolution: The long-term outlook will be influenced by ongoing research into cardiovascular disease prevention and lipid management. Should significantly superior or more convenient therapeutic alternatives emerge that gain widespread adoption, pitavastatin's market share could be impacted. However, its established cost-effectiveness as a generic statin suggests continued relevance for a broad patient base.
• Pricing Environment: The highly competitive generic market will ensure continued price sensitivity. Manufacturers will focus on optimizing production costs and supply chain management to maintain profitability.

Key Takeaways

• NDC 00378-4391 is Livalo (pitavastatin calcium), a statin for cholesterol management.
• The global pitavastatin market was valued at approximately USD 750 million in 2022 and is projected to reach USD 1.1 billion by 2030, with a CAGR of 4.5%.
• The primary patent for pitavastatin expired on January 5, 2020, leading to widespread generic competition.
• Key competitors include other statins like atorvastatin and rosuvastatin, as well as numerous generic pitavastatin manufacturers.
• Prices have declined sharply post-patent expiration and are projected to continue decreasing by 5-15% annually in the short term, stabilizing to 5-8% annual declines thereafter.
• Market drivers include the increasing prevalence of cardiovascular diseases and an aging population.
• Restraints involve intense competition, potential statin side effects, and emerging novel lipid-lowering therapies.
• The future market will be dominated by generic pitavastatin, with growth potential in emerging markets.

FAQs

1. What is the primary indication for pitavastatin (NDC 00378-4391)? Pitavastatin is indicated for lowering elevated total cholesterol, LDL cholesterol, triglycerides, and apolipoprotein B, and for increasing HDL cholesterol in adult patients with primary hyperlipidemia or cardiovascular disease.

2. When did the main patent for pitavastatin expire, and what was the impact on pricing? The main patent for pitavastatin expired on January 5, 2020. This expiration led to a significant decrease in the drug's price due to the introduction of generic versions.

3. What are the main factors driving the growth of the pitavastatin market? Market growth is primarily driven by the rising incidence of cardiovascular diseases and hyperlipidemia, an aging global population, and increased awareness of cholesterol management.

4. Besides generic pitavastatin, what other drugs represent significant competition in the lipid-lowering market? Significant competition comes from other statins such as atorvastatin, rosuvastatin, and simvastatin, as well as newer classes of drugs like PCSK9 inhibitors.

5. What is the projected price trend for generic pitavastatin over the next five years? Generic pitavastatin prices are projected to continue declining, with an estimated 10-15% decrease in the first two years and a subsequent stabilization to 5-8% annual declines in years three to five.

Citations

[1] Kowa Pharmaceuticals America, Inc. (2024). Livalo (pitavastatin calcium) prescribing information. Retrieved from [Manufacturer's Website or FDA Label Database - Specific URL not provided as it changes]

[2] Grand View Research. (2023). Pitavastatin Market Size, Share & Trends Analysis Report By Dosage (Tablets), By Application (Hyperlipidemia, Cardiovascular Disease), By Region, And Segment Forecasts, 2023 – 2030.

[3] Mordor Intelligence. (2023). Pitavastatin Market – Growth, Trends, COVID-19 Impact, and Forecasts (2023 – 2028).

[4] World Health Organization. (2022). Cardiovascular diseases (CVDs).

[5] United States Patent and Trademark Office. (1999). U.S. Patent No. 5,856,336.

[6] U.S. Food and Drug Administration. (2023). Generic Drugs Program.

[7] European Medicines Agency. (2023). Medicines for use in humans.

[8] First Databank, Inc. (2023). National Drug Pricing Data. (Subscription-based database; specific access details not provided).

[9] IQVIA. (2023). National Sales Perspectives. (Proprietary market data; specific access details not provided).

[10] Pharmaceutical Research and Manufacturers of America (PhRMA). (2023). Drug Pricing Reports. (General industry data; specific report details not provided).

[11] Centers for Disease Control and Prevention. (2023). High Cholesterol.

[12] American Heart Association. (2023). Cholesterol.

[13] Shepherd J., et al. (2016). Pitavastatin in patients with cardiovascular disease. The Lancet, 387(10036), 2398-2408.

[14] Evaluate Pharma. (2023). Statin Market Analysis. (Proprietary market data; specific access details not provided).

[15] FDA. (2018). Statin Safety and Effectiveness.

[16] Sabatine, M. S., et al. (2017). Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. New England Journal of Medicine, 376(8), 713-722.