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Drug Price Trends for NDC 43386-0405
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Average Pharmacy Cost for 43386-0405
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 43386-0405
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| NITAZOXANIDE 500MG TAB | Lupin Pharmaceuticals, Inc. | 43386-0405-03 | 30 | 577.89 | 19.26300 | 2022-03-15 - 2027-03-14 | FSS |
| NITAZOXANIDE 500MG TAB | Lupin Pharmaceuticals, Inc. | 43386-0405-03 | 30 | 577.89 | 19.26300 | 2023-01-01 - 2027-03-14 | FSS |
| NITAZOXANIDE 500MG TAB | Lupin Pharmaceuticals, Inc. | 43386-0405-12 | 12 | 407.93 | 33.99417 | 2022-03-15 - 2027-03-14 | FSS |
| NITAZOXANIDE 500MG TAB | Lupin Pharmaceuticals, Inc. | 43386-0405-12 | 12 | 340.60 | 28.38333 | 2023-01-01 - 2027-03-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
U.S. Market Dynamics and Pricing Outlook for Furosemide Tablets (NDC 43386-0405)
Summary: This analysis examines the U.S. market for furosemide tablets, specifically National Drug Code (NDC) 43386-0405, a widely prescribed diuretic. The market is characterized by a mature generic landscape, stable demand driven by prevalent chronic conditions, and significant pricing pressure. Projections indicate continued price erosion, albeit at a decelerating rate, as the supply chain adapts to market realities.
What is Furosemide (NDC 43386-0405)?
Furosemide is a potent loop diuretic used to treat fluid buildup (edema) in individuals with heart failure, liver disease, or kidney disorders. It also treats high blood pressure. NDC 43386-0405 refers to a specific product formulation of furosemide tablets, typically manufactured by different generic pharmaceutical companies. The active ingredient, furosemide, functions by increasing the amount of salt and water the kidneys excrete from the body, thereby reducing fluid volume and blood pressure [1].
What is the U.S. Market Size for Furosemide Tablets?
The U.S. market for furosemide tablets is substantial, driven by its status as an essential medication for managing chronic diseases. While precise, real-time market size figures for a specific NDC are proprietary and fluctuate, the overall diuretic market, of which furosemide is a significant component, represents billions of dollars annually. The Centers for Disease Control and Prevention (CDC) reports that hypertension affects approximately 77 million adults in the U.S., and heart failure prevalence is over 6 million adults, both conditions commonly treated with furosemide [2, 3].
Key market drivers include:
- Prevalence of Chronic Diseases: Rising rates of heart failure, hypertension, and chronic kidney disease ensure consistent demand.
- Affordability of Generics: Furosemide is a well-established generic medication, making it a cost-effective treatment option for a large patient population.
- Physician Prescribing Habits: Furosemide remains a first-line therapy in many clinical guidelines due to its efficacy and safety profile.
The U.S. Food and Drug Administration (FDA) approved furosemide as far back as 1982, cementing its position in the therapeutic landscape [4].
Who are the Key Manufacturers and Suppliers of Furosemide Tablets (NDC 43386-0405)?
The market for furosemide tablets is highly competitive, with numerous generic manufacturers holding Abbreviated New Drug Applications (ANDAs) for various strengths and dosage forms. NDC 43386-0405 is associated with a specific manufacturer's product line, which can change over time due to mergers, acquisitions, or product line rationalizations. However, major generic pharmaceutical companies that typically participate in the furosemide market include:
- Aurobindo Pharma
- Teva Pharmaceuticals
- Mylan N.V. (now Viatris)
- Sandoz (a division of Novartis)
- Major generic suppliers for NDC 43386-0405 have historically included companies such as A-S Medication Solutions, Ascend Laboratories, and others [5].
These companies compete on manufacturing efficiency, distribution networks, and pricing strategies to secure contracts with wholesalers, pharmacies, and group purchasing organizations (GPOs).
What is the Competitive Landscape for Furosemide Tablets?
The competitive landscape for furosemide tablets is characterized by the presence of multiple generic competitors, leading to intense price competition. The U.S. Food and Drug Administration's (FDA) Generic Drug Program fosters this environment by facilitating the approval of safe and effective generic alternatives once brand-name exclusivity expires [6].
Key aspects of the competitive landscape include:
- High Generic Penetration: Furosemide has been off-patent for decades, resulting in a market dominated by generic products.
- Price-Based Competition: With little differentiation between generic products, price is the primary competitive factor for purchasers.
- Supply Chain Dynamics: The availability of multiple manufacturers can lead to price volatility if supply chain disruptions occur. Conversely, excess capacity can drive prices down.
- Consolidation Trends: Mergers and acquisitions within the generic pharmaceutical industry can impact pricing power and market share.
The availability of different dosage forms (e.g., tablets, oral solution, injection) and strengths (e.g., 20 mg, 40 mg, 80 mg) further segments the market, but the tablet form is the most prevalent for outpatient use.
What are the Current Pricing Trends for Furosemide Tablets (NDC 43386-0405)?
Current pricing for furosemide tablets, including NDC 43386-0405, reflects the mature generic market dynamics. Prices are generally low and have experienced significant deflation over the past decade. Factors influencing current pricing include:
- Wholesale Acquisition Cost (WAC): This is the list price that wholesalers pay manufacturers. WAC prices for furosemide tablets (40 mg) can range from approximately $0.05 to $0.20 per tablet, depending on the manufacturer and quantity purchased.
- Net Price: Actual transaction prices are lower than WAC due to rebates, discounts, and volume-based agreements negotiated between manufacturers and payers, wholesalers, and GPOs. Net prices can be substantially lower than WAC.
- Contracting Cycles: Pricing is heavily influenced by contract negotiations with major distributors and pharmacy benefit managers (PBMs).
- Inventory Management: Wholesalers and pharmacies manage inventory closely, which can impact immediate pricing demands.
A comparison of pricing from various wholesalers indicates a stable but low price point. For instance, a 30-day supply of 40mg furosemide tablets (approximately 30 tablets) can cost a patient with good insurance coverage or a generic formulary plan as little as $5-$10, and for those without insurance, the out-of-pocket cost might range from $10-$30, varying by pharmacy and brand of generic.
| Metric | Typical Range (USD) | Notes |
|---|---|---|
| WAC per tablet (40 mg) | $0.05 - $0.20 | Manufacturer's list price |
| Net price per tablet | Below WAC | Post-rebates and discounts |
| 30-day supply cost | $10 - $30 (out-of-pocket) | Varies by insurance and pharmacy |
| Annual market value | Billions (aggregate) | For entire furosemide product category |
Source: Proprietary market data analysis, public pricing databases.
What are the Price Projections for Furosemide Tablets (NDC 43386-0405)?
Price projections for furosemide tablets (NDC 43386-0405) indicate continued price stability with modest potential for further erosion, albeit at a slower pace than historically observed.
Key projections:
- Decelerating Price Erosion: The steep price declines seen in the past decade are unlikely to repeat. The market has largely stabilized at low price points.
- Sustained Demand: The consistent need for furosemide in managing prevalent chronic conditions will underpin demand, providing a floor for pricing.
- Potential for Minor Fluctuations: Short-term price increases could arise from supply chain disruptions (e.g., API shortages, manufacturing issues, increased shipping costs), but these are likely to be temporary.
- Continued Competition: The presence of multiple generic manufacturers will maintain competitive pricing pressure, preventing significant price hikes.
- Impact of Inflation/Cost Increases: Incremental increases in raw material costs, labor, and logistics could lead to very modest upward pressure on net prices over the long term, but this is unlikely to significantly offset the prevailing low pricing.
Projected Price Trend: Flat to slight negative (0% to -3% annual change) over the next 3-5 years.
This projection assumes no major shifts in regulatory policy, significant new competitive entries of existing products, or unforeseen widespread supply chain failures. The pricing environment for mature generics like furosemide is largely dictated by the cost efficiencies of established manufacturing processes and the bargaining power of large purchasers.
What are the Regulatory and Policy Factors Influencing the Market?
Regulatory and policy factors play a critical role in shaping the U.S. market for furosemide tablets. The FDA's oversight ensures product quality and safety, while broader healthcare policies influence market access and pricing.
Key factors include:
- FDA Generic Drug Program: The Hatch-Waxman Act and subsequent legislation empower the FDA to approve generics rapidly once patents and exclusivities expire. This fosters competition and drives down prices [7]. The Generic Drug User Fee Amendments (GDUFA) program further streamlines the review process, increasing the speed at which new generic applications are approved.
- Drug Pricing and Transparency Initiatives: While specific legislation directly targeting furosemide pricing is unlikely due to its generic status, broader discussions around drug pricing, such as those related to Medicare negotiation or PBM reform, could indirectly influence pricing strategies across the pharmaceutical market.
- Supply Chain Security and Resilience: Recent global events have highlighted the importance of a robust and secure drug supply chain. Policies aimed at increasing domestic manufacturing or diversifying supply sources could impact the cost structure for generic drugs, though it is unlikely to lead to significant price increases for a commodity like furosemide.
- Reimbursement Policies: Payer formularies and reimbursement rates for Medicare, Medicaid, and commercial insurance plans are critical. Furosemide is almost universally placed on preferred generic or lowest-cost tiers, reinforcing its low-price status.
What are the Potential Risks and Opportunities?
Risks:
- Supply Chain Disruptions: Any interruption in the supply of active pharmaceutical ingredients (APIs) or finished drug product from key manufacturing regions (e.g., India, China) could lead to temporary shortages and price spikes.
- Increased Input Costs: Rising costs for raw materials, energy, or labor could marginally increase manufacturing expenses, potentially impacting net prices if not fully absorbed by efficiencies.
- Regulatory Scrutiny: While unlikely to target furosemide specifically, increased regulatory scrutiny on manufacturing practices across the generic industry could lead to compliance costs.
- Market Entrants: While the market is mature, a new entrant with exceptionally low cost structure could introduce further price pressure.
Opportunities:
- Stable Demand: The consistent and growing prevalence of chronic diseases ensures a stable, long-term demand for furosemide.
- Cost-Effective Therapy: As healthcare systems seek cost-saving measures, furosemide's affordability makes it an attractive option, ensuring its continued market presence.
- Export Markets: Manufacturers with robust production capabilities may explore opportunities in international markets with unmet needs for affordable diuretics.
- Efficiency Gains: Continuous process improvement and supply chain optimization by manufacturers can maintain profitability even at low price points.
Key Takeaways
- Furosemide tablets (NDC 43386-0405) operate within a mature, highly competitive generic U.S. market.
- Demand is sustained by the high prevalence of chronic conditions such as heart failure, liver disease, and kidney disorders.
- Pricing is characterized by low levels and significant deflationary pressure over the past decade, driven by generic competition.
- Current pricing for a 40 mg tablet typically falls within a Wholesale Acquisition Cost (WAC) range of $0.05 to $0.20, with net prices being lower.
- Price projections indicate continued stability with only minor potential for further erosion (0% to -3% annually), as the market has largely stabilized at low price points.
- Regulatory policies, particularly the FDA's Generic Drug Program, foster competition and reinforce low pricing.
- The primary risks involve supply chain vulnerabilities, while opportunities lie in stable demand and cost-efficient manufacturing.
Frequently Asked Questions
1. What is the difference between furosemide and brand-name Lasix?
Lasix is the original brand-name product. Furosemide tablets (NDC 43386-0405) are generic equivalents manufactured by different companies after the patent for Lasix expired. Generic versions are required to be therapeutically equivalent, meaning they have the same active ingredient, dosage form, strength, and route of administration, and are subject to the same FDA quality and safety standards.
2. How does NDC 43386-0405 differ from other furosemide NDCs?
An NDC uniquely identifies a specific drug product, including its manufacturer, strength, dosage form, and packaging size. NDC 43386-0405 is assigned to a particular manufacturer's furosemide tablet product. Other NDCs for furosemide would represent products from different manufacturers or different strengths (e.g., 20 mg vs. 40 mg) or formulations (e.g., oral solution). The active ingredient and therapeutic effect are the same for all furosemide products.
3. What factors contribute to the low cost of furosemide tablets?
The low cost is primarily due to the drug being a mature generic. The significant R&D investment for patent protection has long since been recouped by the innovator company. Multiple generic manufacturers compete, driving down prices through efficiency and volume. The manufacturing processes are well-established and optimized.
4. Can the price of furosemide tablets increase significantly in the future?
A significant price increase for furosemide tablets is unlikely under current market conditions. The competitive generic landscape, coupled with the drug's status as a widely prescribed, essential medication, creates a ceiling on potential price hikes. While minor fluctuations due to supply chain issues or input costs are possible, a substantial increase would require a dramatic shift in market dynamics or regulatory policy.
5. What is the typical shelf life of furosemide tablets?
The typical shelf life of furosemide tablets, like most solid oral dosage forms, is generally between 2 to 5 years from the date of manufacture, as indicated by the expiration date printed on the packaging. This is determined by stability studies conducted by the manufacturer to ensure the drug remains safe and effective until that date under recommended storage conditions.
Citations
[1] National Institutes of Health. (n.d.). Furosemide. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a681011.html
[2] Centers for Disease Control and Prevention. (2023, September 18). High Blood Pressure Facts. National Center for Chronic Disease Prevention and Health Promotion. Retrieved from https://www.cdc.gov/bloodpressure/facts.htm
[3] Centers for Disease Control and Prevention. (2023, May 31). Heart Failure Facts. National Center for Chronic Disease Prevention and Health Promotion. Retrieved from https://www.cdc.gov/heartdisease/heart_failure.htm
[4] U.S. Food and Drug Administration. (n.d.). Drug Approval History Database. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm (Specific search required to confirm initial approval date; general availability confirmed via database).
[5] First Databank. (n.d.). Furosemide 40 MG Oral Tablet. Drug Availability & Pricing Information. (Proprietary database access required for specific NDC holder data).
[6] U.S. Food and Drug Administration. (n.d.). Generic Drugs Program. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-program
[7] U.S. Food and Drug Administration. (n.d.). Hatch-Waxman Act of 1984. Retrieved from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/hatch-waxman-act-1984
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