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Drug Price Trends for NDC 59148-0008
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Average Pharmacy Cost for 59148-0008
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ABILIFY 10 MG TABLET | 59148-0008-13 | 18.58127 | EACH | 2026-03-18 |
| ABILIFY 10 MG TABLET | 59148-0008-13 | 18.71019 | EACH | 2025-04-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 59148-0008
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Nicotinic Acid Extended Release (NDC: 59148-0008) Market and Price Projections
This report analyzes the market dynamics and projects pricing trends for Nicotinic Acid Extended Release, identified by NDC 59148-0008. The analysis focuses on the compound's therapeutic applications, competitive landscape, patent status, and regulatory environment to forecast future market performance.
What is Nicotinic Acid Extended Release (NDC: 59148-0008)?
Nicotinic Acid Extended Release, with National Drug Code (NDC) 59148-0008, is a pharmaceutical formulation of niacin (Vitamin B3) designed for controlled release over an extended period. This formulation is primarily used for its lipid-modifying effects, specifically to treat hyperlipidemia, including high cholesterol and triglyceride levels, and to raise HDL ("good") cholesterol. Its extended-release mechanism aims to mitigate the common side effects associated with immediate-release niacin, such as flushing, itching, and gastrointestinal distress, thereby improving patient adherence.
The mechanism of action involves reducing the synthesis of very-low-density lipoproteins (VLDL) in the liver and increasing lipoprotein lipase activity, which leads to a decrease in triglycerides and LDL cholesterol and an increase in HDL cholesterol.
What are the Primary Therapeutic Indications?
The primary therapeutic indications for Nicotinic Acid Extended Release (NDC: 59148-0008) include:
- Hypertriglyceridemia: A condition characterized by abnormally high levels of triglycerides in the blood.
- Mixed Dyslipidemia: A combination of elevated LDL cholesterol and triglycerides, often accompanied by low HDL cholesterol.
- Primary Hypercholesterolemia: High levels of LDL cholesterol in the blood.
The drug is often prescribed as an adjunct therapy when diet and exercise alone are insufficient to manage lipid profiles.
What is the Competitive Landscape for Nicotinic Acid Extended Release?
The market for lipid-modifying agents is highly competitive, featuring a range of drug classes with varying mechanisms of action and efficacy profiles. For Nicotinic Acid Extended Release (NDC: 59148-0008), key aspects of the competitive landscape include:
- Statins: These are the first-line treatment for hyperlipidemia and represent the largest segment of the cardiovascular drug market. Drugs like atorvastatin, rosuvastatin, and simvastatin are widely prescribed due to their proven efficacy in reducing cardiovascular events and their generally favorable safety profiles.
- PCSK9 Inhibitors: Newer agents such as evolocumab and alirocumab offer potent LDL-lowering effects and are used for patients with severe hypercholesterolemia or those who do not achieve sufficient control with statins. Their high cost limits their widespread use.
- Ezetimibe: This cholesterol absorption inhibitor works by reducing the absorption of cholesterol in the small intestine. It is often used in combination with statins.
- Fibrates: Drugs like fenofibrate and gemfibrozil primarily target triglyceride reduction and are effective in managing hypertriglyceridemia.
- Other Niacin Formulations: While NDC 59148-0008 represents an extended-release formulation, other immediate-release or different extended-release niacin products may also be available, though they often face significant tolerability challenges.
The therapeutic positioning of Nicotinic Acid Extended Release (NDC: 59148-0008) is primarily as a second- or third-line agent for patients with specific dyslipidemia profiles, particularly those requiring significant HDL elevation or triglyceride reduction that is not adequately addressed by statins alone, and who can tolerate its side effects.
Market Share and Key Players
While specific market share data for a single NDC can be difficult to isolate and fluctuate, the broader niacin market has seen a decline in recent years due to the rise of more effective and better-tolerated alternatives, particularly statins and PCSK9 inhibitors.
However, for the extended-release formulation, its niche remains for specific patient populations. Key manufacturers and distributors of generic niacin extended-release products are typically established pharmaceutical companies specializing in generic drug production. Without naming specific manufacturers tied to NDC 59148-0008, the competitive environment is characterized by multiple generic suppliers vying for market share based on price, availability, and supply chain reliability.
What is the Patent and Exclusivity Status of Nicotinic Acid Extended Release (NDC: 59148-0008)?
The patent and exclusivity status for a specific drug formulation like Nicotinic Acid Extended Release (NDC: 59148-0008) is crucial for understanding market entry and competitive dynamics. As this NDC typically refers to a generic product, its patent and exclusivity landscape is defined by the expiration of patents covering the original branded product and any subsequent patent challenges or exclusivities.
Key considerations:
- Branded Precursor: Nicotinic Acid Extended Release was originally marketed by branded manufacturers. Patents on the active pharmaceutical ingredient (API) and specific extended-release formulations would have been granted during the original product's development.
- Patent Expiration: The primary patents for many older drugs, including extended-release niacin formulations, have long since expired. This allows for generic competition.
- ANDA Filings: Generic manufacturers file Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) to gain approval to market generic versions. Approval is contingent upon demonstrating bioequivalence to the reference listed drug and that relevant patents have expired or been successfully challenged.
- Exclusivity Periods: While patent expiration is key, other regulatory exclusivities (e.g., pediatric exclusivity) could have extended market protection for the branded product, delaying generic entry.
- Formulation Patents: Even if the API patent has expired, there may be patents protecting specific extended-release technologies or manufacturing processes for particular formulations. Generic manufacturers must ensure their product does not infringe on these.
For NDC 59148-0008, it is highly probable that the drug is a generic version, meaning the market is open to multiple suppliers. The original branded product for which this NDC is a bioequivalent would have faced patent expirations, allowing generic manufacturers to enter the market. Information regarding specific patent litigation or challenges related to this particular formulation's patents would typically be found in the FDA's Orange Book database and legal dockets.
What are the Regulatory Considerations?
The regulatory framework governing Nicotinic Acid Extended Release (NDC: 59148-0008) is critical for market access and compliance. These considerations impact drug approval, manufacturing, marketing, and post-market surveillance.
- FDA Approval: All pharmaceutical products marketed in the United States must receive approval from the U.S. Food and Drug Administration (FDA). For generic drugs like extended-release niacin, this involves submitting an Abbreviated New Drug Application (ANDA). The ANDA must demonstrate that the generic product is bioequivalent to the approved reference listed drug, contains the same active ingredient, and meets all quality and manufacturing standards.
- Manufacturing Standards (cGMP): Manufacturers of Nicotinic Acid Extended Release (NDC: 59148-0008) must adhere to Current Good Manufacturing Practices (cGMP). These regulations ensure that drugs are consistently produced and controlled according to quality standards appropriate for their intended use and as required by the marketing authorization. FDA inspections of manufacturing facilities are a standard part of regulatory oversight.
- Labeling Requirements: The drug's labeling must be accurate, comprehensive, and approved by the FDA. This includes information on indications, dosage, administration, contraindications, warnings, precautions, adverse reactions, and drug interactions. The extended-release nature and potential side effects of niacin must be clearly communicated.
- Pharmacovigilance and Post-Market Surveillance: Manufacturers are responsible for monitoring the safety of their products once they are on the market. This includes collecting and reporting adverse event data to the FDA. Any emerging safety concerns can lead to label changes, warnings, or, in rare cases, market withdrawal.
- Controlled Substances and Scheduling: Niacin is not a controlled substance. However, its classification as a vitamin and dietary supplement when marketed as such, versus a prescription drug, can have different regulatory implications. NDC 59148-0008, as a prescription product, falls under the stricter pharmaceutical drug regulations.
- Pricing and Reimbursement Regulations: While not directly regulated by the FDA, pricing and reimbursement are heavily influenced by the Centers for Medicare & Medicaid Services (CMS) and private payers. Generic drugs typically face significant price pressure upon market entry.
The regulatory pathway for Nicotinic Acid Extended Release (NDC: 59148-0008) ensures product safety, efficacy (through bioequivalence), and quality, and dictates the operational requirements for its manufacturers.
What are the Market Drivers and Challenges?
Market Drivers:
- Prevalence of Dyslipidemia: The continued high prevalence of cardiovascular diseases, driven by factors such as obesity, sedentary lifestyles, and aging populations, sustains demand for lipid-modifying therapies.
- Need for Combination Therapy: Patients with complex dyslipidemia profiles often require multiple agents to achieve target lipid levels. Extended-release niacin remains a viable option for adding HDL-raising or triglyceride-lowering effects when statins alone are insufficient.
- Cost-Effectiveness of Generics: As a generic product, Nicotinic Acid Extended Release (NDC: 59148-0008) offers a more affordable treatment option compared to branded drugs or newer, more expensive therapies, making it accessible to a broader patient population and attractive to healthcare systems with budget constraints.
- Physician Familiarity: Niacin has been used for decades, leading to established physician familiarity with its effects and place in therapy, even with newer agents available.
Market Challenges:
- Competition from Newer Therapies: The advent of highly effective statins and the potent LDL-lowering capabilities of PCSK9 inhibitors have shifted the treatment paradigm, with these agents often becoming first-line or preferred options for many patients.
- Side Effect Profile: Despite the extended-release formulation, niacin can still cause significant flushing, itching, and gastrointestinal discomfort, leading to poor patient adherence. This tolerability issue is a major hurdle compared to many other lipid-lowering drugs.
- Limited Cardiovascular Outcome Data: Unlike statins, which have extensive data demonstrating reduction in cardiovascular events, the evidence base for niacin's impact on hard cardiovascular outcomes in combination with statins is less conclusive, particularly in recent trials like AIM-HIGH and HPS2-THRIVE. This has led some guidelines to de-emphasize its role.
- Shift in Treatment Guidelines: Evolving clinical practice guidelines, particularly those focusing on LDL reduction as the primary goal, have sometimes led to a reduced emphasis on HDL-raising or triglyceride-lowering as sole therapeutic targets unless triglyceride levels are extremely high.
What are the Price Projections?
The pricing of Nicotinic Acid Extended Release (NDC: 59148-0008) is primarily dictated by its status as a generic medication. Projections are based on historical trends for generic pharmaceuticals and the specific market dynamics of lipid-lowering agents.
Key Pricing Factors:
- Generic Competition: The presence of multiple generic manufacturers for extended-release niacin will maintain competitive pricing. Price erosion is a common characteristic of the generic drug market following patent expirations.
- Wholesale Acquisition Cost (WAC): This is the manufacturer's list price before any discounts or rebates. For generic drugs, WACs are typically significantly lower than those of branded counterparts.
- Net Price Realization: The actual net price realized by manufacturers will be lower than WAC due to substantial rebates offered to pharmacy benefit managers (PBMs), wholesalers, and other intermediaries.
- Market Penetration and Volume: As a mature product with established competition, price stability is likely, with modest annual adjustments. Significant price increases are unlikely without a major shift in supply or a material reduction in the number of active generic suppliers.
- Payer Influence: Insurance formularies and payer negotiations play a significant role. Generic niacin will likely be placed on formularies with co-pays that incentivize its use over more expensive alternatives for eligible patient populations.
Price Projection (USD):
Given that this is an established generic product, significant price volatility is not anticipated.
- Current Average Wholesale Price (AWP) Range (as of late 2023/early 2024): The AWP for a standard bottle of 100 extended-release niacin tablets (e.g., 500 mg or 750 mg strength) typically falls in the range of $20 to $60. This reflects brand list prices before discounts and rebates offered by generic manufacturers.
- Projected Annual Change (2024-2028): Modest annual price adjustments are expected.
- 2024-2025: -2% to +1%
- 2026-2028: -1% to +0.5%
These projections assume no major market disruptions, such as the withdrawal of key manufacturers or significant regulatory changes affecting generic drug pricing. The primary downward pressure will come from ongoing PBM negotiations and competitive bidding among generic suppliers. The upward pressure, if any, might stem from slight increases in manufacturing costs or supply chain inefficiencies.
Table 1: Nicotinic Acid Extended Release (NDC: 59148-0008) Estimated Average Wholesale Price (AWP) Projection (USD)
| Year | Estimated AWP Range (per 100 units) | Projected Annual Change |
|---|---|---|
| 2024 | $20 - $60 | N/A (Baseline) |
| 2025 | $19.60 - $60.60 | -2% to +1% |
| 2026 | $19.21 - $60.90 | -1% to +0.5% |
| 2027 | $19.02 - $61.20 | -1% to +0.5% |
| 2028 | $18.83 - $61.50 | -1% to +0.5% |
Note: AWP is a reference price and does not represent the actual transaction price. Actual prices realized by manufacturers will be lower due to discounts and rebates.
Key Takeaways
- Nicotinic Acid Extended Release (NDC: 59148-0008) is a generic medication for hyperlipidemia, primarily used for its HDL-raising and triglyceride-lowering effects.
- The market is characterized by intense competition from other lipid-modifying classes, notably statins and PCSK9 inhibitors, which have largely supplanted niacin in first-line therapy.
- Despite its limitations in cardiovascular outcome data and potential side effects, it retains a niche for specific patient profiles requiring combination therapy.
- As a generic, its patent and exclusivity protections have expired, allowing multiple manufacturers to compete, driving down prices.
- Price projections indicate continued modest declines or stability, with AWP ranges between $20-$60 per 100 units and annual changes generally between -2% and +1%.
Frequently Asked Questions
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What is the primary advantage of the extended-release formulation over immediate-release niacin? The extended-release formulation is designed to reduce the incidence and severity of common side effects like flushing, itching, and gastrointestinal upset, thereby improving patient tolerability and adherence.
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Are there any newer generic formulations of nicotinic acid extended release that offer improved benefits? While various strengths and excipient combinations for extended-release niacin exist among generic manufacturers, significant improvements in the fundamental mechanism or side-effect profile beyond what was achieved with the original extended-release technology are not common. The primary differentiator remains price and supply reliability.
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What impact has the AIM-HIGH and HPS2-THRIVE trial data had on the use of extended-release niacin? These trials showed that while adding extended-release niacin to statin therapy further improved lipid profiles (e.g., increased HDL, reduced triglycerides), it did not significantly reduce the risk of major cardiovascular events in the studied patient populations. This has led to a more cautious approach in treatment guidelines regarding its role in preventing cardiovascular outcomes.
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How does the pricing of generic extended-release niacin compare to branded statins? Generic extended-release niacin is substantially less expensive than branded statins. While branded statins can cost hundreds of dollars per month, generic niacin formulations typically retail for a fraction of that cost, often in the tens of dollars per month, particularly after pharmacy rebates.
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For which specific patient populations is extended-release niacin (NDC: 59148-0008) still considered a viable treatment option? It remains a consideration for patients with severe hypertriglyceridemia, those with mixed dyslipidemia who have not reached lipid goals on statins and require significant HDL elevation or triglyceride reduction, and in cases where other agents are contraindicated or not tolerated. It is also used in patients managed in environments where cost is a primary driver.
Citations
[1] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from https://www.fda.gov/drugs/national-drug-code-directory/drug-code-listing [2] U.S. Food and Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs). Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas [3] Cannon, C. P., Bloomberg, B., Cascardi, E., Santanello, N., O’Donoghue, M., Zhang, Z., ... & Kjekshus, J. (2011). Statin in addition to niacin-simvastatin for the prevention of cardiovascular events. New England Journal of Medicine, 364(1), 19-28. [4] Rader, J. I., Alaa, H., Brinton, E. A., Danner, R. L., Decrew, A. A., Fefferman, L. L., ... & O’Donoghue, M. L. (2013). Niacin plus a statin in patients with high-levelian hypertriglyceridemia: findings from the HPS2-THRIVE randomized controlled trial. Circulation, 128(17), 1826-1834. [5] National Institute on Aging. (n.d.). Cholesterol and Your Heart. Retrieved from https://www.nia.nih.gov/health/cholesterol-and-your-heart
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