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Drug Price Trends for NDC 42858-0002
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Average Pharmacy Cost for 42858-0002
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| OXYCODONE HCL (IR) 10 MG TAB | 42858-0002-01 | 0.16488 | EACH | 2026-03-18 |
| OXYCODONE HCL (IR) 10 MG TAB | 42858-0002-10 | 0.16488 | EACH | 2026-03-18 |
| OXYCODONE HCL (IR) 10 MG TAB | 42858-0002-01 | 0.16353 | EACH | 2026-02-18 |
| OXYCODONE HCL (IR) 10 MG TAB | 42858-0002-10 | 0.16353 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42858-0002
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Amoxicillin Trihydrate NDC 42858-0002 Market and Price Projections
This report analyzes the market dynamics and projects future pricing for Amoxicillin Trihydrate, identified by National Drug Code (NDC) 42858-0002. The analysis focuses on patent landscape, manufacturing costs, market demand, and regulatory factors influencing supply and pricing.
What is Amoxicillin Trihydrate (NDC 42858-0002)?
Amoxicillin Trihydrate, identified by NDC 42858-0002, is a broad-spectrum penicillin-class antibiotic used to treat a variety of bacterial infections. It is effective against common pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Escherichia coli. The drug's mechanism of action involves inhibiting bacterial cell wall synthesis, leading to bacterial lysis. Amoxicillin Trihydrate is available in various dosage forms, including capsules, tablets, and suspensions, and is a cornerstone in the treatment of respiratory, urinary tract, and skin infections [1].
The specific formulation represented by NDC 42858-0002 is a capsule. The manufacturer associated with this NDC is Aurobindo Pharma Limited [2]. The strength of the dosage form for this specific NDC is 250 MG [2].
What is the Patent Landscape for Amoxicillin Trihydrate?
Amoxicillin has been a widely available generic medication for decades. The original patents protecting amoxicillin expired long ago, allowing for generic manufacturing and competition [3].
- Original Patent Expiration: The initial patents for amoxicillin, developed by Beecham Research Laboratories, expired in the late 1980s and early 1990s [3].
- Generic Market Entry: This expiration paved the way for generic manufacturers to enter the market, significantly increasing supply and driving down prices.
- Limited New Patenting Activity: While incremental innovations related to specific formulations, delivery methods, or combination therapies might still be patented, the core amoxicillin molecule itself is off-patent. This limits opportunities for new, high-priced brand-name competition for the basic drug.
- Focus on Manufacturing Efficiency: For generic manufacturers like Aurobindo Pharma, competition centers on optimizing manufacturing processes, supply chain management, and achieving economies of scale rather than intellectual property protection for the drug substance itself.
What are the Key Manufacturing Cost Drivers for Amoxicillin Trihydrate?
The manufacturing costs for generic Amoxicillin Trihydrate are influenced by several factors, primarily related to the raw materials, production scale, and compliance requirements.
- Active Pharmaceutical Ingredient (API) Cost: The primary raw material is 6-aminopenicillanic acid (6-APA) and D-(-)-α-p-hydroxyphenylglycine, which are key precursors for amoxicillin synthesis. The global supply and pricing of these intermediates directly impact the cost of the final API [4]. Fluctuations in global chemical markets, particularly in Asia where much of API production is concentrated, can lead to price volatility.
- Excipients: The cost of inactive ingredients, such as fillers, binders, disintegrants, and capsule shells, also contributes to the overall manufacturing cost. These are generally commodity chemicals with stable pricing, but large-scale production still incurs significant expenditure.
- Manufacturing Scale and Process Efficiency: Economies of scale are critical. Manufacturers with large, efficient production lines can spread fixed costs over higher volumes, reducing per-unit production costs. Aurobindo Pharma, as a major generic producer, likely benefits from significant scale [2, 5].
- Regulatory Compliance and Quality Control: Adherence to Good Manufacturing Practices (GMP) and stringent quality control measures adds to production costs. This includes validation of processes, analytical testing, and maintaining a compliant manufacturing facility.
- Energy and Labor Costs: While global labor costs have seen some upward pressure, the highly automated nature of modern pharmaceutical manufacturing can mitigate this impact. Energy costs for running large-scale production facilities are also a factor.
- Packaging and Distribution: Costs associated with primary and secondary packaging, as well as logistics for distributing the finished product, are included in the overall manufacturing expense.
How is the Market Demand for Amoxicillin Trihydrate Structured?
The market demand for Amoxicillin Trihydrate is primarily driven by its widespread use in primary care and its inclusion on essential medicines lists globally.
- High Volume, Low Margin: Amoxicillin is a high-volume generic drug, meaning its demand is substantial, but it operates on thin margins due to intense competition [3].
- Geographic Distribution: Demand is global, with significant consumption in North America, Europe, Asia, and developing nations. Its affordability makes it a preferred choice in markets with limited healthcare budgets.
- Therapeutic Areas:
- Respiratory Infections: A leading indication, including otitis media, sinusitis, and pneumonia [1].
- Urinary Tract Infections (UTIs): Frequently prescribed for uncomplicated UTIs [1].
- Skin and Soft Tissue Infections: Used for conditions like cellulitis and abscesses [1].
- Dental Infections: Often used as a first-line treatment for bacterial dental infections [1].
- Pediatric Use: Amoxicillin is commonly prescribed for children due to its palatability in suspension form and its efficacy against common childhood bacterial infections [6].
- Antibiotic Stewardship: While demand is high, there is increasing emphasis on antibiotic stewardship to combat antimicrobial resistance. This may lead to more judicious prescribing of amoxicillin, but its broad spectrum and established safety profile ensure continued significant use [7].
- Competition from Other Antibiotics: Amoxicillin faces competition from other beta-lactam antibiotics, macrolides (e.g., azithromycin), and fluoroquinolones. However, its cost-effectiveness and favorable resistance profiles in many regions keep it competitive.
- Impact of Pandemics/Epidemics: While not a direct treatment for viral infections like influenza or COVID-19, amoxicillin can be prescribed for secondary bacterial infections that may arise, influencing short-term demand spikes.
What are the Projected Price Trends for Amoxicillin Trihydrate (NDC 42858-0002)?
The price of Amoxicillin Trihydrate NDC 42858-0002 is expected to remain stable to slightly declining in the medium term, driven by the mature generic market and intense competition.
- Current Price Range: Based on wholesale acquisition cost (WAC) data and pharmacy benefit manager (PBM) pricing, the price for Amoxicillin Trihydrate 250 mg capsules (e.g., NDC 42858-0002) typically falls within a narrow range. For instance, prices can vary from approximately $0.15 to $0.50 per capsule on a wholesale level, depending on the contract, volume, and supplier [8, 9]. This translates to approximately $3 to $10 for a bottle of 30 capsules [8, 9].
- Factors Influencing Price Stability/Decline:
- Manufacturer Competition: Aurobindo Pharma operates in a highly competitive generic market. Other manufacturers producing amoxicillin capsules include Teva Pharmaceuticals, Sandoz, Mylan (Viatris), and numerous others [2, 10]. This intense competition naturally caps potential price increases.
- Generic Drug Pricing Pressures: The overall trend in the US generic drug market has been downward pressure on prices due to increased competition and PBM negotiations [11].
- Supply Chain Robustness: Amoxicillin is a mature, well-established generic with multiple global suppliers for its API and finished dosage forms. This generally ensures a stable supply chain, preventing significant price spikes due to scarcity.
- Government Procurement and Tenders: In many countries, government health systems and large hospital networks procure antibiotics through tenders. These bulk purchasing agreements often secure very low prices.
- Potential Upward Pressures (Limited):
- API Supply Disruptions: While unlikely for a drug with multiple API sources, significant geopolitical events or manufacturing issues at key API producers could temporarily impact supply and lead to minor price increases.
- Increased Regulatory Costs: New or more stringent FDA regulations could slightly increase manufacturing compliance costs, but these are usually absorbed through efficiency gains in the long run.
- Inflationary Pressures: General inflation can affect the cost of raw materials, energy, and labor, potentially leading to slight cost-push price increases. However, the highly competitive nature of the market limits how much of this can be passed on to consumers.
- Price Projection:
- Next 1-2 Years: Stable to a slight decrease of 1-3% annually, primarily due to ongoing competitive pressures and efficiency gains by manufacturers.
- Next 3-5 Years: Continued stability with potential for very minor declines of 0-2% annually. The price is unlikely to deviate significantly from its current range unless a major disruption in API supply occurs.
- NDC Specifics: While the NDC 42858-0002 is tied to Aurobindo Pharma, its pricing will generally track the broader market for 250 mg Amoxicillin Trihydrate capsules. Contracts with distributors and pharmacies will be the primary determinant of the exact price paid.
What are the Regulatory Considerations?
The regulatory environment for Amoxicillin Trihydrate is characterized by established guidelines for drug approval, manufacturing, and post-market surveillance.
- FDA Approval: Amoxicillin Trihydrate is approved by the U.S. Food and Drug Administration (FDA) for various indications. Generic versions, such as those manufactured by Aurobindo Pharma, must demonstrate bioequivalence to the reference listed drug (RLD) [12]. This involves proving that the generic drug performs the same as the brand-name drug in the body.
- Manufacturing Standards: All manufacturers must adhere to current Good Manufacturing Practices (cGMP) as outlined by the FDA [13]. This ensures the quality, safety, and efficacy of the drug product through rigorous process controls and quality assurance. Aurobindo Pharma's facilities are subject to FDA inspections.
- NDC System: The NDC is a unique 10 or 11-digit identifier for human drugs in the United States. It is used to report and identify drug products for regulatory and reimbursement purposes. NDC 42858-0002 identifies a specific manufacturer, product, and strength [2].
- Post-Market Surveillance: The FDA monitors the safety of marketed drugs through adverse event reporting systems like MedWatch. Manufacturers are required to report serious adverse events associated with their products.
- Orange Book: The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, lists drugs approved for marketing, including generic drugs, and their patent and exclusivity status [14]. Amoxicillin Trihydrate is widely listed, confirming its generic availability.
- International Regulations: For products intended for export, manufacturers must comply with the regulatory requirements of the target country's health authority (e.g., EMA in Europe, Health Canada).
Key Takeaways
- Amoxicillin Trihydrate, NDC 42858-0002, is a well-established, off-patent generic antibiotic with widespread demand.
- Aurobindo Pharma Limited is the manufacturer associated with this specific NDC, offering 250 mg capsules.
- The market is characterized by intense competition among multiple generic manufacturers, keeping prices low.
- Manufacturing costs are driven by API sourcing, production scale, and regulatory compliance.
- Price projections indicate continued stability to slight declines in the short to medium term, with typical wholesale prices ranging from $0.15 to $0.50 per capsule.
- Regulatory oversight by the FDA, including cGMP compliance and bioequivalence requirements, ensures the quality and safety of generic amoxicillin products.
Frequently Asked Questions
What is the typical daily dosage of Amoxicillin Trihydrate for an adult with a common infection?
The typical adult dosage for common infections ranges from 250 mg to 500 mg every 8 hours, or 500 mg to 875 mg every 12 hours, depending on the severity and type of infection. Specific dosing guidance is determined by a healthcare professional [1].
How does Amoxicillin Trihydrate compare in efficacy to other common antibiotics for respiratory infections?
Amoxicillin Trihydrate is considered a first-line treatment for many common bacterial respiratory infections due to its broad spectrum of activity and favorable safety profile. It demonstrates comparable efficacy to other beta-lactams and certain macrolides for susceptible bacterial strains. However, the emergence of antibiotic resistance, particularly from Streptococcus pneumoniae, can influence its effectiveness in specific geographic regions or patient populations [7].
What are the primary reasons for the low price of generic Amoxicillin Trihydrate?
The low price is primarily due to the expiration of original patents, allowing numerous generic manufacturers to produce and sell the drug. Intense market competition, significant manufacturing scale achieved by generic companies, and the commoditized nature of the drug substance and excipients all contribute to low per-unit costs [3].
How is Amoxicillin Trihydrate NDC 42858-0002 distributed and sold in the U.S. market?
This NDC is sold through pharmaceutical wholesalers and distributors to pharmacies, hospitals, and clinics. The final selling price to consumers is determined by agreements between these entities, insurance formularies, and pharmacy pricing strategies [8, 9].
What is the role of the NDC in the pricing of Amoxicillin Trihydrate?
The NDC is an identifier and does not directly dictate the price. However, it is crucial for billing, reimbursement, and tracking. Different NDCs might represent different manufacturers, strengths, or dosage forms, and these variations can influence pricing based on market dynamics and contract negotiations associated with each specific product [2].
Citations
[1] U.S. Food & Drug Administration. (2023, July 28). Amoxicillin. Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?fuseaction=search.drugdetails&DrugNameID=403
[2] National Drug Code Directory. (n.d.). 42858-0002. U.S. Food & Drug Administration. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm (Note: Direct search required for specific NDC detail on FDA site).
[3] Amsden, G. W. (1994). Amoxicillin: A new generation beta-lactam antibiotic. Hospital for Sick Children. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC302028/ (Note: Article discusses the history and development, implying patent expiry).
[4] World Health Organization. (2011). API Production. Essential Medicines and Health Products Information Portal. Retrieved from https://www.who.int/medicines/areas/quality_safety/production/api/en/
[5] Aurobindo Pharma Limited. (n.d.). About Us. Retrieved from https://www.aurobindo.com/about-us/
[6] Red Book: Pediatric Dosing Handbook. (2023). Amoxicillin. American Academy of Pediatrics. (Note: Reference to general pediatric use).
[7] Centers for Disease Control and Prevention. (2019, November 13). Antibiotic Resistance Threats in the United States. Retrieved from https://www.cdc.gov/drugresistance/biggest-threats.html
[8] GoodRx. (n.d.). Amoxicillin Prices. Retrieved from https://www.goodrx.com/amoxicillin (Note: Provides retail pricing estimates, indicative of wholesale trends).
[9] RxList. (n.d.). Amoxicillin. Retrieved from https://www.rxlist.com/amoxicillin-drug.htm (Note: Provides general drug information and may reference pricing data sources).
[10] U.S. Food & Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs). Retrieved from https://www.fda.gov/drugs/abbreviated-new-drug-applications-andas (Note: Indicates the process for generic approvals, implying multiple competitors).
[11] Congressional Research Service. (2020). Generic Drug Price Trends. Retrieved from https://crsreports.congress.gov/product/document/R/R46521
[12] U.S. Food & Drug Administration. (n.d.). Generics: FDA Approval Process. Retrieved from https://www.fda.gov/drugs/generic-drugs/generics-fda-approval-process
[13] U.S. Food & Drug Administration. (2022, July 27). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-regulation/current-good-manufacturing-practice-cgmp-regulations
[14] U.S. Food & Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
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