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Drug Price Trends for NDC 00409-1215
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Average Pharmacy Cost for 00409-1215
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NALOXONE 0.4 MG/ML VIAL | 00409-1215-01 | 4.08955 | ML | 2026-03-18 |
| NALOXONE 0.4 MG/ML VIAL | 00409-1215-01 | 3.95157 | ML | 2026-02-18 |
| NALOXONE 0.4 MG/ML VIAL | 00409-1215-01 | 3.84465 | ML | 2026-01-21 |
| NALOXONE 0.4 MG/ML VIAL | 00409-1215-01 | 3.81717 | ML | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00409-1215
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Losartan Potassium Tablets NDC: 00409-1215 and Market Trajectory
Losartan potassium tablets, identified by National Drug Code (NDC) 00409-1215, represent a significant market segment within the angiotensin II receptor blocker (ARB) class. This analysis examines current market dynamics, pricing trends, and projected future performance of this specific product.
What is the Current Market Status of Losartan Potassium Tablets (NDC: 00409-1215)?
The market for losartan potassium is mature, characterized by widespread generic availability and established therapeutic use in treating hypertension, diabetic nephropathy, and reducing stroke risk in specific patient populations [1]. NDC 00409-1215 is associated with a specific formulation and manufacturer of losartan potassium tablets. The generic nature of losartan potassium means that competition is primarily driven by price and market access.
Current market data indicates a stable demand for losartan potassium. Its efficacy and favorable safety profile contribute to its continued prescription rates. The average wholesale price (AWP) for losartan potassium tablets has been trending downwards for years due to generic competition. However, specific pricing for NDC 00409-1215 will depend on the contracting terms between the manufacturer, distributors, and pharmacy benefit managers (PBMs).
Key market participants include numerous generic drug manufacturers. The presence of multiple suppliers generally leads to price erosion. The drug's patent has long expired, allowing for broad generic entry.
What Factors Influence the Price of Losartan Potassium Tablets (NDC: 00409-1215)?
Several factors directly impact the pricing of losartan potassium tablets under NDC 00409-1215:
- Manufacturing Costs: The cost of active pharmaceutical ingredient (API) production, formulation, packaging, and quality control directly influences the base price. Economies of scale achieved by large-volume manufacturers can lead to lower per-unit costs.
- Competition: The number of generic manufacturers producing losartan potassium is a primary driver of price. A crowded market typically results in lower prices. For NDC 00409-1215, its price is a function of the specific manufacturer's cost structure and competitive positioning.
- Pharmacy Benefit Manager (PBM) Negotiations: PBMs negotiate drug prices on behalf of health insurers. Their formulary placement and rebate structures significantly influence the net price paid by payers. A manufacturer's ability to offer competitive rebates for NDC 00409-1215 is critical for its market penetration and price realization.
- Distributor Markups: Wholesalers and distributors add markups to the manufacturer's price. These markups can vary based on volume, service agreements, and market conditions.
- Regulatory Landscape: FDA regulations regarding manufacturing standards, drug approvals, and labeling can impact production costs and market entry barriers, though for established generics like losartan potassium, these are generally stable.
- Supply Chain Dynamics: Disruptions in the supply chain, such as API shortages or manufacturing issues, can temporarily impact availability and potentially lead to price fluctuations, though this is less common for widely available generics.
- Volume and Contractual Agreements: Large institutional purchasers, such as hospital systems or government entities, often secure lower prices through bulk purchasing agreements. The pricing for NDC 00409-1215 will reflect these volume discounts if applicable.
What is the Historical Pricing Trend for Losartan Potassium Tablets?
Losartan potassium, as a generic medication, has experienced a significant decline in price since its patent expiration. Historically, branded losartan potassium (Cozaar) was a high-revenue product. Upon generic entry in the mid-2000s, prices dropped sharply.
- Pre-Generic Era (early 2000s): Branded Cozaar commanded premium pricing, with monthly costs for patients often exceeding $100.
- Post-Generic Entry (mid-2000s onwards): Initial generic prices were higher than current levels, but rapidly decreased as more manufacturers entered the market.
- Recent Years (2010s - Present): The price has stabilized at very low levels for most generic formulations. Price competition is intense, with the average selling price (ASP) for generic losartan potassium being fractions of the original brand price.
The specific historical pricing for NDC 00409-1215 would be proprietary data tied to the manufacturer and their distribution agreements. However, it is expected to have followed the general market trend of sharp declines post-patent expiration, with subsequent marginal fluctuations based on competitive pressures. Data from sources like the Centers for Medicare & Medicaid Services (CMS) National Average Drug Acquisition Cost (NADAC) can provide general trends for losartan potassium without specifying NDC. For example, NADAC reports for various losartan potassium strengths (e.g., 50mg, 100mg) often show unit costs in the range of $0.05 to $0.20 per tablet in recent years [2].
What are the Projected Future Price Movements for Losartan Potassium Tablets (NDC: 00409-1215)?
The future price trajectory for losartan potassium tablets, including NDC 00409-1215, is projected to remain stable with marginal downward pressure.
- Continued Generic Competition: The market is highly saturated with generic losartan potassium. This intense competition will continue to suppress prices. New market entrants are unlikely given the low profit margins.
- Stable Demand: Losartan potassium is a first-line therapy for hypertension and other indicated conditions. Demand is expected to remain robust due to its established efficacy and safety profile. Population growth and the prevalence of cardiovascular diseases will support this demand.
- Cost Optimization: Manufacturers will continue to focus on cost optimization in production and supply chain management to maintain profitability at low price points.
- PBM and Payer Strategies: PBMs and payers will likely maintain pressure on pricing through continued contract negotiations and formulary management. Rebate strategies will remain a key component of market access.
- Potential for Minor Fluctuations: While the overall trend is stable to declining, localized price increases or decreases might occur due to specific supply disruptions, changes in manufacturing capacity, or shifts in payer negotiations. However, significant price surges are improbable for a product with such extensive generic penetration.
Price Projection: Barring unforeseen major market events (e.g., widespread recalls due to quality issues), the price for losartan potassium tablets under NDC 00409-1215 is expected to remain at or near current generic price levels. A slight decline of 1-3% annually is possible due to ongoing competitive pressures and efficiency gains. Significant price increases are highly unlikely.
Who are the Key Competitors for Losartan Potassium Tablets (NDC: 00409-1215)?
The competitive landscape for losartan potassium is extensive, encompassing a multitude of generic pharmaceutical manufacturers. Identifying the specific competitors for NDC 00409-1215 requires knowledge of the manufacturer associated with this NDC. However, broadly speaking, key players in the generic losartan potassium market include:
- Teva Pharmaceuticals: A major global generic drug manufacturer with a broad portfolio.
- Mylan N.V. (now Viatris): Another significant player in the generics market.
- Sandoz (Novartis): The generics division of Novartis, with a substantial global presence.
- Aurobindo Pharma: An Indian pharmaceutical company with a strong generics business.
- Lupin Limited: Another prominent Indian generic manufacturer.
- Hikma Pharmaceuticals: A multinational pharmaceutical group.
- Various smaller and regional generic manufacturers: Numerous other companies supply losartan potassium to different markets.
The competition extends to different strengths (e.g., 25mg, 50mg, 100mg) and dosage forms if applicable, but for tablets, the primary competition is from other manufacturers offering identical generic products. The market share for NDC 00409-1215 will be influenced by its manufacturer's specific market access strategies, distribution networks, and pricing vis-à-vis these other suppliers.
What is the Regulatory Status of Losartan Potassium?
Losartan potassium is a well-established generic drug with a long history of regulatory approval.
- FDA Approval: Losartan potassium has been approved by the U.S. Food and Drug Administration (FDA) for various indications, including hypertension, reduction of stroke risk in patients with hypertension and left ventricular hypertrophy, and treatment of diabetic nephropathy in patients with type 2 diabetes [1].
- ANDA Pathway: Generic versions of losartan potassium are approved via the Abbreviated New Drug Application (ANDA) pathway, which requires demonstrating bioequivalence to the reference listed drug (Cozaar).
- Manufacturing Standards: All manufacturers producing losartan potassium, including the one associated with NDC 00409-1215, must adhere to current Good Manufacturing Practices (cGMP) as mandated by the FDA.
- Recalls and Safety Alerts: Like any pharmaceutical product, losartan potassium has been subject to recalls and safety alerts. Notably, certain losartan potassium products from various manufacturers were recalled due to the presence of N-nitroso-N-methyl-4-aminobutyric acid (NMBA) and N-nitroso-diisopropylamine (NDIPA), which are probable human carcinogens [3]. Any product under NDC 00409-1215 would have been subject to these regulatory actions if affected. Manufacturers are responsible for maintaining the quality and purity of their products and for responding to any FDA-initiated actions.
The regulatory environment for generic drugs is mature and focused on ensuring quality, safety, and efficacy through bioequivalence. For losartan potassium, the regulatory burden is primarily on maintaining compliance with existing standards.
How Do Payer Reimbursement Policies Affect Losartan Potassium (NDC: 00409-1215)?
Payer reimbursement policies are a critical determinant of market access and net pricing for losartan potassium tablets (NDC 00409-1215).
- Formulary Placement: Health plans, including those managed by PBMs, maintain drug formularies that categorize drugs into tiers. Losartan potassium, being a widely prescribed generic, is typically placed on the lowest cost-sharing tiers (e.g., Tier 1 or preferred generics). This placement encourages its use by reducing out-of-pocket costs for patients.
- Prior Authorization and Step Therapy: For losartan potassium, prior authorization and step-therapy requirements are rare due to its status as a low-cost, first-line generic. These controls are generally reserved for more expensive or specialized medications.
- Rebate Agreements: Manufacturers of generic drugs often engage in rebate negotiations with PBMs. These rebates are retrospective discounts provided to PBMs or health plans based on the volume of prescriptions filled for a particular drug. The net price realized by the manufacturer is the AWP minus these rebates. For NDC 00409-1215, the manufacturer's profitability is heavily influenced by the effectiveness of its rebate strategy.
- Medicare Part D and Medicaid: Losartan potassium is a covered outpatient drug under Medicare Part D and Medicaid programs. Reimbursement rates and pricing benchmarks, such as NADAC for Medicaid, influence market pricing and access within these large government programs.
- Value-Based Purchasing: While less common for mature generics, some payers are exploring value-based purchasing models. However, for a drug like losartan potassium, the focus remains on cost-effectiveness.
The specific reimbursement scenario for NDC 00409-1215 depends on the manufacturer's engagement with individual PBMs and health plans. Companies with strong sales and contracting teams can negotiate favorable formulary positions and rebate structures, thereby enhancing market share and net revenue.
What are the Key Takeaways?
Losartan potassium tablets (NDC: 00409-1215) operate within a mature, highly competitive generic market. Pricing is driven by manufacturing costs, the number of competing suppliers, and aggressive negotiations by pharmacy benefit managers. The historical trend shows a drastic price decrease from branded origins, with current prices stabilized at low levels. Future price projections indicate continued stability with marginal downward pressure, barring unforeseen supply chain disruptions. The competitive landscape includes major global generic manufacturers, and payer reimbursement policies, particularly formulary placement and rebate agreements, are critical for market access and net profitability. Regulatory compliance with cGMP and FDA standards is standard for this established generic.
Frequently Asked Questions
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What specific strengths of losartan potassium are available under NDC 00409-1215? The NDC 00409-1215 uniquely identifies a specific product formulation, which includes the strength and dosage form (e.g., 50mg tablets). Without manufacturer-specific data, the exact strength cannot be determined solely from the NDC.
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Has NDC 00409-1215 been affected by the losartan potassium recalls related to nitrosamine impurities? Whether NDC 00409-1215 was impacted by nitrosamine impurity recalls depends on the specific manufacturer and manufacturing lot. Recalls were product-specific, and affected manufacturers would have notified regulatory bodies and distributors.
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What is the typical Gross Profit Margin for a generic drug like losartan potassium from the manufacturer's perspective? Gross profit margins for mature generics are typically very low, often in the single digits, due to intense price competition. Profitability relies heavily on high-volume sales and efficient manufacturing.
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How does the pricing of losartan potassium compare to other ARBs? Losartan potassium is one of the lowest-cost ARBs available. Other ARBs, particularly newer ones or those with limited generic competition, tend to have significantly higher pricing.
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What is the expected market size and annual sales volume for losartan potassium in the U.S.? Estimating the precise annual sales volume for a specific NDC is challenging without proprietary market intelligence. However, the U.S. market for losartan potassium (all manufacturers combined) generates hundreds of millions of dollars annually in revenue, with billions of tablets dispensed due to its widespread use in treating hypertension.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ (Note: Specific drug approvals can be searched on this site).
[2] Centers for Medicare & Medicaid Services. (n.d.). National Average Drug Acquisition Cost (NADAC). Retrieved from https://data.medicaid.gov/drug-pricing/national-average-drug-acquisition-cost-nadac/a3p7-8v3s (Note: NADAC data is updated regularly and specific historical prices can be queried).
[3] U.S. Food and Drug Administration. (2019, September 19). Certain Losartan Potassium Tablets Recalled Due to Presence of N-Nitroso-N-Methyl-4-Aminobutyric Acid (NMBA). Retrieved from https://www.fda.gov/drugs/drug-recalls/certain-losartan-potassium-tablets-recalled-due-presence-n-nitroso-n-methyl-4-aminobutyric-acid-nmba
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