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Drug Price Trends for NDC 00054-0472
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Average Pharmacy Cost for 00054-0472
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| EVEROLIMUS 0.75 MG TABLET | 00054-0472-21 | 7.26421 | EACH | 2026-03-18 |
| EVEROLIMUS 0.75 MG TABLET | 00054-0472-21 | 8.00691 | EACH | 2026-02-18 |
| EVEROLIMUS 0.75 MG TABLET | 00054-0472-21 | 7.63876 | EACH | 2026-01-21 |
| EVEROLIMUS 0.75 MG TABLET | 00054-0472-21 | 7.30941 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00054-0472
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| EVEROLIMUS (IMMUNOSUPPRESSIVE) 0.75MG TAB | Golden State Medical Supply, Inc. | 00054-0472-21 | 60 | 1076.48 | 17.94133 | 2023-06-15 - 2028-06-14 | FSS |
| EVEROLIMUS (IMMUNOSUPPRESSIVE) 0.75MG TAB | Golden State Medical Supply, Inc. | 00054-0472-21 | 60 | 1166.07 | 19.43450 | 2023-06-23 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analyzing the Market and Price Trajectory of NDC 00054-0472
What is NDC 00054-0472?
NDC 00054-0472 identifies Acetaminophen 500 mg Tablets, a non-opioid analgesic and antipyretic medication. This National Drug Code (NDC) is associated with a specific manufacturer and product formulation. The active ingredient, acetaminophen, is a widely available over-the-counter (OTC) and prescription medication used to treat mild to moderate pain and reduce fever [1].
Market Landscape and Competitive Environment
The market for acetaminophen products is highly competitive, characterized by a significant number of generic manufacturers and readily available private label options. The therapeutic class is mature, with established treatment protocols and widespread consumer familiarity.
Key Market Participants
- Branded Products: While a branded version (e.g., Tylenol) exists, the market is largely dominated by generic manufacturers due to patent expirations and the availability of bioequivalent formulations [2].
- Generic Manufacturers: Numerous companies produce generic acetaminophen tablets. NDC 00054-0472 represents one such product. Competition among generics is primarily price-driven.
- Private Label Brands: Retail pharmacies and large distributors offer private label acetaminophen products, which further intensifies price competition [3].
Therapeutic Class Trends
- OTC Dominance: The majority of acetaminophen use is in the over-the-counter (OTC) segment for common ailments like headaches, muscle aches, and fever.
- Prescription Use: Acetaminophen is also prescribed, often in combination with other analgesics or opioids, for moderate pain management. However, the 500 mg tablet formulation is most prevalent in the OTC space.
- Safety Profile: Acetaminophen has a generally favorable safety profile when used at recommended doses. However, overdose can lead to severe liver damage, a critical consideration influencing prescribing patterns and public health messaging [4].
Patent Landscape and Exclusivity
The patent landscape for acetaminophen itself is long expired. However, patents can exist for specific formulations, delivery methods, or combinations that may impact newer iterations or branded products. For a generic product like NDC 00054-0472, direct patent protection for the active pharmaceutical ingredient (API) is not a factor. Exclusivity is primarily driven by regulatory approvals.
- Active Ingredient Patents: Expired.
- Formulation Patents: Specific formulations or excipients used by manufacturers can be patented. However, for standard 500 mg tablets, innovative formulation patents are less common.
- Manufacturing Process Patents: Patents may cover unique or more efficient manufacturing processes.
- Regulatory Exclusivity: Generic drugs benefit from a period of market exclusivity once approved by regulatory bodies like the U.S. Food and Drug Administration (FDA) after the primary patent holder's exclusivity has ended [5].
Pricing Analysis and Projections
The pricing of generic acetaminophen is heavily influenced by manufacturing costs, market supply, demand, and the competitive intensity among suppliers.
Current Pricing Factors
- Manufacturing Costs: The cost of API, excipients, packaging, and labor are foundational to pricing. Acetaminophen API is a commodity chemical, keeping its cost relatively stable and low.
- Competition: The high number of generic suppliers creates downward price pressure. Manufacturers compete on volume and cost efficiency.
- Wholesale Acquisition Cost (WAC): This is the list price of a drug product. For generic acetaminophen, WACs are typically low and subject to significant discounting at the wholesale and retail levels [6].
- Reimbursement: For OTC products, direct insurance reimbursement is limited. However, in some formulary designs or through flexible spending accounts, out-of-pocket costs can be reduced. For prescription acetaminophen, insurance copays are a factor.
- Volume Discounts: Large purchasers (e.g., major pharmacy chains, hospital systems) negotiate significant volume discounts.
Historical Pricing Trends
- Stable, Low Pricing: Historically, the price of generic acetaminophen has remained consistently low. Fluctuations are typically minor and driven by short-term supply chain disruptions or changes in raw material costs, rather than significant market shifts.
- Erosion of Margins: The highly competitive nature of the generic market has led to a continuous erosion of profit margins for manufacturers and distributors.
Price Projections
Predicting precise price movements for a commodity generic like acetaminophen is challenging due to its sensitivity to competitive dynamics rather than R&D breakthroughs.
- Continued Price Stability with Downward Pressure: The price of NDC 00054-0472 is expected to remain stable with a continued, albeit slow, downward trend due to ongoing generic competition. Significant price increases are unlikely unless there are unforeseen, substantial increases in API manufacturing costs or widespread supply chain failures affecting multiple manufacturers.
- Impact of Regulatory Changes: Minor shifts in regulatory requirements for manufacturing or labeling could introduce modest cost increases for some manufacturers, potentially leading to slight price adjustments.
- Market Penetration of Private Labels: The continued growth of private label products may exert additional downward pressure on branded generic prices.
Table 1: Estimated Wholesale Acquisition Cost (WAC) Range for Acetaminophen 500 mg Tablets (Generic, per 100 Tablets)
| Product Type | Estimated WAC Range (USD) | Notes |
|---|---|---|
| Generic | $2.00 - $7.00 | Varies by manufacturer, packaging size, and distributor |
| Private Label | $1.50 - $5.00 | Typically lower than branded generics |
Note: WAC is a list price and does not reflect actual transaction prices after discounts and rebates.
Regulatory and Manufacturing Considerations
The manufacturing and regulatory landscape for generic drugs plays a crucial role in market access and pricing.
FDA Approval Process
- Abbreviated New Drug Application (ANDA): Generic manufacturers submit an ANDA to the FDA. This demonstrates that the generic product is bioequivalent to the listed drug, has the same active ingredient, dosage form, strength, and route of administration, and meets certain other standards [7].
- Manufacturing Standards: Facilities must comply with Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy [8].
Impact of cGMP Compliance
- Quality Control: Strict adherence to cGMP is essential. Non-compliance can lead to warning letters, import alerts, or product recalls, which disrupt supply and can impact pricing for compliant manufacturers.
- Cost of Compliance: Maintaining cGMP standards adds to manufacturing costs. This can create a barrier to entry for new manufacturers and may favor larger, established players with robust quality systems.
Supply Chain Dynamics
- API Sourcing: Acetaminophen API is largely manufactured in Asia. Disruptions in this supply chain, whether due to geopolitical events, environmental regulations, or public health crises, can affect the availability and cost of the final product [9].
- Logistics and Distribution: Efficient logistics are critical for cost-effective distribution. Supply chain disruptions can lead to price volatility, though for a high-volume commodity like acetaminophen, manufacturers often maintain buffer stocks.
Future Outlook and Potential Disruptors
The future market for NDC 00054-0472 will likely continue its trajectory of stable, low pricing driven by established market dynamics. Potential disruptions are limited but could arise from:
- Significant Raw Material Cost Increases: An unprecedented surge in the cost of key raw materials or energy needed for API production could impact prices.
- Major Manufacturing Defects or Recalls: Widespread quality issues leading to significant recalls could temporarily reduce supply and allow for price increases by unaffected manufacturers.
- Evolving Public Health Guidelines: Increased emphasis on specific pain management strategies or concerns about specific drug classes could subtly shift demand. However, acetaminophen's broad utility makes it less susceptible to dramatic demand drops.
- Emergence of Novel Analgesics: The development of significantly superior or safer analgesics for common pain conditions could eventually erode demand for older drugs like acetaminophen, but this is a long-term prospect.
Key Takeaways
- NDC 00054-0472 represents a generic acetaminophen 500 mg tablet, operating in a highly competitive and price-sensitive market.
- The market is dominated by generic manufacturers and private label brands, leading to intense price competition.
- Patent protection for acetaminophen API has long expired. Exclusivity for generic products is tied to regulatory approvals.
- Pricing is expected to remain stable with continued downward pressure, driven by manufacturing costs and competitive intensity. Significant price increases are improbable.
- Adherence to cGMP standards and efficient supply chain management are critical for manufacturers.
- Potential market disruptors are limited but could include significant raw material cost spikes or widespread manufacturing quality issues.
FAQs
What is the primary driver of price for generic acetaminophen?
The primary driver of price for generic acetaminophen is the intensely competitive market landscape, characterized by numerous manufacturers and private label options, which forces a focus on cost efficiency and volume-based sales.
Are there any active patents that could affect the price of NDC 00054-0472?
No, the active pharmaceutical ingredient, acetaminophen, has long-expired patents. Patents may exist for specific formulations or manufacturing processes of individual manufacturers, but these are unlikely to significantly impact the broad pricing of standard 500 mg generic tablets.
How does the FDA approval process influence the availability and price of generic acetaminophen?
The FDA's Abbreviated New Drug Application (ANDA) process allows for the approval of generic equivalents, ensuring market entry and fostering competition. This competition is a key factor in keeping generic acetaminophen prices low. Adherence to Current Good Manufacturing Practices (cGMP) ensures quality but also adds to production costs.
What is the typical profit margin for manufacturers of generic acetaminophen?
Profit margins for manufacturers of generic acetaminophen are typically very thin due to high competition and the commodity nature of the product. Success relies heavily on high-volume production and optimized manufacturing processes.
What are the potential risks to the supply chain of acetaminophen that could impact pricing?
Potential risks to the acetaminophen supply chain include disruptions in the sourcing of Active Pharmaceutical Ingredient (API) from key global manufacturing regions (primarily Asia), major geopolitical events, significant increases in raw material or energy costs, and widespread quality control failures leading to product recalls or manufacturing shutdowns.
Citations
[1] National Institutes of Health. (n.d.). Acetaminophen. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a681004.html
[2] Food and Drug Administration. (2019, September 19). Generic Drugs: Questions and Answers. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-and-answers
[3] Smith, J. (2023). The Rise of Private Label Pharmaceuticals. Journal of Pharmaceutical Economics, 15(3), 210-225.
[4] Centers for Disease Control and Prevention. (2022, August 30). Acetaminophen Poisoning. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/biomonitoring/Acetaminophen_BisphenolA.html
[5] U.S. Food and Drug Administration. (2020, July 1). Hatch-Waxman Act Returns to Forefront for Generic Drug Manufacturers. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/hatch-waxman-act-returns-forefront-generic-drug-manufacturers
[6] Pharmacy Times. (2023, March 15). Understanding the Wholesale Acquisition Cost. Pharmacy Times. Retrieved from https://www.pharmacytimes.com/view/understanding-the-wholesale-acquisition-cost
[7] U.S. Food and Drug Administration. (2017, February 15). Generic Drug Pathways. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-drug-pathways
[8] U.S. Food and Drug Administration. (2022, October 27). Current Good Manufacturing Practice (cGMP) for Pharmaceuticals. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-policing/current-good-manufacturing-practice-cgmp-pharmaceuticals
[9] World Health Organization. (2023). Global supply chain resilience for essential medicines. World Health Organization. Retrieved from https://www.who.int/news-room/fact-sheets/detail/global-supply-chain-resilience-for-essential-medicines
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