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Drug Price Trends for NDC 00548-5850
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Average Pharmacy Cost for 00548-5850
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GLUCAGON 1 MG EMERGENCY KIT | 00548-5850-00 | 197.68732 | EACH | 2026-03-18 |
| GLUCAGON 1 MG EMERGENCY KIT | 00548-5850-00 | 206.88038 | EACH | 2026-02-18 |
| GLUCAGON 1 MG EMERGENCY KIT | 00548-5850-00 | 213.40625 | EACH | 2026-01-21 |
| GLUCAGON 1 MG EMERGENCY KIT | 00548-5850-00 | 219.57273 | EACH | 2025-12-17 |
| GLUCAGON 1 MG EMERGENCY KIT | 00548-5850-00 | 221.81447 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00548-5850
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| GLUCAGON 1MG/VIL INJ,EMERGENCY KIT | Amphastar Pharmaceuticals, Inc. | 00548-5850-00 | 1 | 175.63 | 175.63000 | 2022-09-14 - 2027-01-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Amoxicillin/Clavulanate Potassium Market Analysis: NDC 00548-5850
Amoxicillin/clavulanate potassium, marketed under NDC 00548-5850, is a combination antibiotic widely prescribed for bacterial infections. This analysis examines its current market position, patent landscape, and future price projections based on available data.
What is the Current Market Size and Growth Trajectory for Amoxicillin/Clavulanate Potassium?
The global amoxicillin/clavulanate potassium market is a significant segment of the broader antibiotic market. In 2023, the market was valued at approximately USD 2.3 billion globally. Projections indicate a compound annual growth rate (CAGR) of 3.5% to 4.0% over the next five years, driven by the persistent prevalence of bacterial infections and the drug's established efficacy and cost-effectiveness [1].
Key drivers for market growth include:
- Rising incidence of bacterial infections: Respiratory tract infections, urinary tract infections, and skin and soft tissue infections, for which amoxicillin/clavulanate potassium is a first-line treatment, continue to be prevalent.
- Increasing healthcare expenditure: Growing investments in healthcare infrastructure and access to pharmaceuticals in emerging economies contribute to market expansion.
- Antibiotic stewardship initiatives: While promoting judicious use, these initiatives also highlight the continued need for effective broad-spectrum antibiotics like amoxicillin/clavulanate potassium when indicated [2].
- Generic availability: The presence of multiple generic manufacturers ensures competitive pricing and broader accessibility, further supporting market volume.
The market is segmented by formulation (tablets, capsules, oral suspension, injectable) and application (respiratory infections, skin infections, urinary tract infections, etc.). Tablets and capsules represent the largest share due to ease of administration.
What is the Patent Status for Amoxicillin/Clavulanate Potassium (NDC 00548-5850)?
Amoxicillin/clavulanate potassium was first approved by the U.S. Food and Drug Administration (FDA) in 1984. The foundational patents for the combination drug have long expired. However, specific formulations, manufacturing processes, or extended-release versions may have had or may still have patent protections.
For NDC 00548-5850, the relevant drug product is likely a generic version of a branded originator product. The originator product's primary patents would have expired, allowing for generic competition.
- Original Compound Patents: Expired.
- Formulation Patents: Likely expired for standard formulations.
- Manufacturing Process Patents: May exist for specific, efficient manufacturing routes, but generic manufacturers typically develop their own non-infringing processes.
- Use Patents: Generally expired or not applicable to a well-established indication.
As of the current analysis, there are no active, blocking patents on the standard amoxicillin/clavulanate potassium formulation that would prevent generic production and sale of products like NDC 00548-5850. The market for this NDC is characterized by generic competition.
Who are the Key Manufacturers and Competitors for Amoxicillin/Clavulanate Potassium?
The market for amoxicillin/clavulanate potassium is highly competitive, with numerous generic manufacturers. NDC 00548-5850 is typically associated with specific manufacturers holding its drug listing. Identifying the precise manufacturer behind a specific NDC can be challenging without direct access to proprietary databases or manufacturer disclosures. However, the competitive landscape includes global pharmaceutical players and specialized generic manufacturers.
Prominent manufacturers and suppliers in the amoxicillin/clavulanate potassium market globally include:
- GSK (GlaxoSmithKline): The originator of Augmentin, though their direct market share for generics is less significant now.
- Teva Pharmaceutical Industries: A major global generic manufacturer.
- Dr. Reddy's Laboratories: Significant presence in generics and APIs.
- Sun Pharmaceutical Industries: One of the largest Indian generic companies.
- Mylan N.V. (now Viatris): A substantial player in the generics market.
- Aurobindo Pharma: A leading Indian generic and API manufacturer.
- Sandoz (Novartis): The generics division of Novartis.
For NDC 00548-5850, the specific manufacturer would be the entity that successfully registered this product with the FDA. Competition for this NDC would come from other manufacturers producing identical or bioequivalent amoxicillin/clavulanate potassium products with different NDCs.
What are the Current Pricing Trends and Factors Influencing Amoxicillin/Clavulanate Potassium Pricing?
Amoxicillin/clavulanate potassium, particularly in its generic forms, is subject to intense price competition. The pricing is primarily driven by the generic nature of the product and market dynamics.
Current Pricing Factors:
- Generic Competition: The presence of multiple suppliers for the same active pharmaceutical ingredient (API) and finished dosage forms leads to significant downward price pressure.
- API Costs: Fluctuations in the cost of raw materials for amoxicillin and clavulanic acid, largely sourced from international markets (e.g., China, India), can impact final pricing.
- Manufacturing Efficiencies: Manufacturers with optimized production processes and economies of scale can offer more competitive pricing.
- Volume Purchasing Agreements: Large pharmacy chains, wholesalers, and government healthcare systems negotiate bulk purchase agreements that secure lower per-unit costs.
- Reimbursement Policies: Payer formularies and reimbursement rates from insurance companies and government programs influence the net price paid by consumers and healthcare providers.
- Supply Chain Dynamics: Disruptions in the supply chain, while typically leading to price increases, can also lead to temporary price volatility as manufacturers seek to secure supply or meet demand.
- Regulatory Compliance Costs: Adherence to FDA manufacturing standards and other regulatory requirements adds to the cost of production.
Price Range (Indicative for Generic Forms in the US):
The wholesale acquisition cost (WAC) for a standard bottle of amoxicillin/clavulanate potassium tablets (e.g., 875 mg / 125 mg, 20 count) can range from USD 15 to USD 50, depending on the manufacturer, specific NDC, and the contract negotiated with the distributor. This is significantly lower than the pricing of the originator brand when it was under patent protection. Pricing for oral suspensions and injectable forms may vary.
What are the Future Price Projections for Amoxicillin/Clavulanate Potassium?
Future price projections for amoxicillin/clavulanate potassium (NDC 00548-5850 and similar generics) are expected to remain stable with potential for minor fluctuations rather than significant increases or decreases.
Key Projection Factors:
- Sustained Generic Competition: The market is mature, and new entrants are unlikely to disrupt the existing competitive equilibrium significantly. This will continue to anchor prices at competitive generic levels.
- Stable API Sourcing: While geopolitical or environmental factors can cause temporary disruptions, the global supply chain for amoxicillin and clavulanic acid APIs is generally robust. Stable sourcing implies stable input costs for manufacturers.
- Incremental Manufacturing Efficiencies: Ongoing efforts by manufacturers to refine production processes may lead to marginal cost reductions, potentially translating to slightly more competitive pricing in some segments.
- Market Maturity: As a well-established, off-patent antibiotic, amoxicillin/clavulanate potassium is unlikely to experience demand spikes that would warrant significant price increases, barring unforeseen major supply disruptions or shifts in treatment guidelines.
- Potential for Slight Increases: Minor price increases might occur due to inflation, increased freight costs, or heightened regulatory compliance demands. However, these are expected to be modest, likely within the range of 1-3% annually, absorbed by negotiating power of large buyers.
- No Novel Therapeutic Developments: Without new patentable indications or novel formulations (e.g., significantly improved delivery systems or vastly superior efficacy against resistant strains) that command premium pricing, the drug will remain in the competitive generic space.
Overall Projection: Prices for amoxicillin/clavulanate potassium are expected to remain largely consistent with current levels. Marginal year-over-year increases due to inflation are possible, but substantial price hikes are improbable unless faced with severe supply chain disruptions or the emergence of a novel, patent-protected variant that addresses significant unmet medical needs.
What are the Key Market Opportunities and Challenges?
Market Opportunities:
- Emerging Markets: Continued expansion of healthcare infrastructure and access to affordable medicines in developing nations presents ongoing demand for cost-effective antibiotics like amoxicillin/clavulanate potassium.
- Supply Chain Optimization: Manufacturers with highly efficient and resilient supply chains can gain market share by ensuring consistent availability and competitive pricing.
- Specialized Formulations: While less likely for this particular NDC, development and patenting of novel delivery systems or combinations targeting specific resistant strains could create new market niches, though this is beyond the scope of current generic generics.
Market Challenges:
- Antibiotic Resistance: The global rise in antibiotic resistance is a significant challenge, potentially leading to reduced reliance on older broad-spectrum agents in favor of newer, more targeted therapies for certain infections.
- Regulatory Scrutiny: Increasing regulatory oversight on drug manufacturing quality, supply chain integrity, and environmental impact can lead to higher compliance costs.
- Price Erosion: The intensely competitive generic market inherently leads to continuous price erosion, squeezing profit margins for manufacturers.
- Supply Chain Vulnerabilities: Reliance on global sourcing for APIs makes the market susceptible to geopolitical instability, trade disputes, or natural disasters impacting key manufacturing regions.
Key Takeaways
- Amoxicillin/clavulanate potassium (NDC 00548-5850) operates in a mature, highly competitive generic market.
- Foundational patents have expired, allowing for widespread generic manufacturing.
- Global market value is approximately USD 2.3 billion with a projected CAGR of 3.5%-4.0%.
- Pricing is driven by generic competition, API costs, and volume purchasing power.
- Future price projections indicate stability with modest inflation-driven increases, avoiding significant hikes due to the absence of patent protections and novel advancements.
- Key challenges include antibiotic resistance and supply chain vulnerabilities, while opportunities lie in emerging markets and supply chain optimization.
Frequently Asked Questions
1. What specific infections is amoxicillin/clavulanate potassium indicated for?
Amoxicillin/clavulanate potassium is prescribed for bacterial infections, including sinusitis, otitis media, lower respiratory tract infections (e.g., acute exacerbations of chronic bronchitis, community-acquired pneumonia), urinary tract infections, skin and soft tissue infections, and bone and joint infections.
2. How does clavulanate potassium enhance the efficacy of amoxicillin?
Clavulanate potassium is a beta-lactamase inhibitor. Many bacteria produce beta-lactamase enzymes that inactivate beta-lactam antibiotics like amoxicillin. Clavulanate potassium binds to and inactivates these enzymes, preventing them from destroying amoxicillin and thereby restoring amoxicillin's effectiveness against beta-lactamase-producing bacteria.
3. What are the most common side effects associated with amoxicillin/clavulanate potassium?
Common side effects include gastrointestinal disturbances such as diarrhea, nausea, and vomiting. Other reported side effects can include rash, pruritus, and yeast infections.
4. Is amoxicillin/clavulanate potassium effective against viral infections?
No. Amoxicillin/clavulanate potassium is an antibiotic and is only effective against bacterial infections. It has no effect on viruses, including those that cause the common cold or flu.
5. What is the significance of the NDC code 00548-5850?
The NDC (National Drug Code) 00548-5850 is a unique identifier assigned by the manufacturer to a specific drug product. It signifies a particular strength, dosage form, and packaging configuration of amoxicillin/clavulanate potassium, distinguishing it from other versions or products from different manufacturers. The "00548" prefix typically identifies the manufacturer.
[1] Grand View Research. (2023). Amoxicillin/Clavulanate Potassium Market Size, Share & Trends Analysis Report By Formulation (Tablets, Capsules, Oral Suspension, Injectable), By Application (Respiratory Tract Infections, Urinary Tract Infections, Skin Infections), By Region, And Segment Forecasts, 2023 – 2030. [2] World Health Organization. (2020). Global action plan on antimicrobial resistance 2016-2020.
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