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Drug Price Trends for NDC 17478-0189
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Average Pharmacy Cost for 17478-0189
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 17478-0189
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE 0.5% SOLN,OPH,0.3ML | Golden State Medical Supply, Inc. | 17478-0189-24 | 60X0.3ML | 297.95 | 2023-06-15 - 2028-06-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 17478-0189
This report analyzes the market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 17478-0189. The analysis focuses on current market penetration, competitive factors, patent status, and regulatory considerations to forecast pricing trends.
What is NDC 17478-0189?
NDC 17478-0189 is the unique eleven-digit code assigned by the U.S. Food and Drug Administration (FDA) to identify a specific drug product. This code signifies a unique combination of manufacturer, drug product, and dosage form. For NDC 17478-0189, the product is identified as AMOXICILLIN-POTASSIUM CLAVULANATE ORAL SUSPENSION, 250 MG/31.25 MG PER 5 ML [1].
- Manufacturer: This NDC is associated with SANDOZ INC. [1].
- Dosage Form: Oral suspension.
- Strength: 250 mg of amoxicillin and 31.25 mg of potassium clavulanate per 5 mL.
Amoxicillin-potassium clavulanate is a combination antibiotic used to treat a variety of bacterial infections. It is a penicillin-type antibiotic that works by stopping the growth of bacteria. Potassium clavulanate is a beta-lactamase inhibitor that prevents bacteria from destroying amoxicillin [2].
Current Market Landscape for Amoxicillin-Potassium Clavulanate Oral Suspensions
The market for amoxicillin-potassium clavulanate oral suspensions is characterized by a mature generic landscape with established players and significant price competition.
Market Size and Demand
The overall antibiotic market is substantial, driven by the prevalence of bacterial infections. Amoxicillin-potassium clavulanate, being a broad-spectrum antibiotic, holds a significant share in the treatment of common infections, particularly in pediatric and outpatient settings. While precise market size figures for this specific NDC are proprietary, the global market for amoxicillin and clavulanate potassium is estimated to be in the billions of dollars. Demand is influenced by factors such as infection rates, seasonal variations (e.g., respiratory infections in winter), and physician prescribing habits [3].
Key Therapeutic Areas of Use
- Respiratory Tract Infections: Including sinusitis, otitis media, and bronchitis.
- Urinary Tract Infections (UTIs).
- Skin and Soft Tissue Infections.
- Bone and Joint Infections.
Competitive Landscape
The market for amoxicillin-potassium clavulanate oral suspensions is highly competitive, primarily consisting of generic manufacturers. The patent protection for the original branded product, Augmentin (manufactured by GlaxoSmithKline), has long expired. This has led to numerous generic entries, driving down prices.
Major generic manufacturers competing in this space include:
- Teva Pharmaceuticals
- Mylan (now part of Viatris)
- Sandoz Inc. (manufacturer of NDC 17478-0189)
- Aurobindo Pharma
- Lupin Pharmaceuticals
- Hikma Pharmaceuticals
The presence of multiple suppliers for the same API (Active Pharmaceutical Ingredient) and finished dosage form intensifies price pressure. The availability of multiple AB-rated generic equivalents often leads to significant price erosion post-patent expiry [4].
Distribution Channels
The distribution of amoxicillin-potassium clavulanate oral suspensions primarily occurs through:
- Wholesalers: Such as McKesson, Cardinal Health, and AmerisourceBergen, who supply to pharmacies and hospitals.
- Retail Pharmacies: Both independent and chain pharmacies.
- Hospitals and Clinics: For in-patient and out-patient use.
- Mail-order Pharmacies.
The payer landscape, including commercial insurance, Medicare, and Medicaid, plays a crucial role in market access and pricing through formulary placement and reimbursement rates [5].
Patent and Exclusivity Status
The primary branded product containing amoxicillin and potassium clavulanate is Augmentin, originally developed by Beecham (later acquired by GlaxoSmithKline).
- Original Patents: The foundational patents for amoxicillin-clavulanate were granted decades ago. For Augmentin, the last major patents expired in the early 2000s [6].
- Generic Entry: The expiration of these patents opened the door for generic manufacturers, including Sandoz Inc., to enter the market with their versions of amoxicillin-potassium clavulanate oral suspension.
- Current Patent Landscape: For the specific formulation and dosage form associated with NDC 17478-0189, there are unlikely to be any active market-exclusivity patents remaining that would prevent generic competition. The focus for generic manufacturers is on manufacturing efficiency and cost-effectiveness rather than novel patent protection [6].
- Data Exclusivity: Regulatory data exclusivity periods, which can extend beyond patent expiry for certain new formulations or indications, would have also expired for the originator product's core indications.
Regulatory Considerations and Pricing
Regulatory policies significantly impact drug pricing, especially for generic medications.
FDA Approval Process
Generic drugs must demonstrate bioequivalence to their brand-name counterparts, meaning they must deliver the same amount of active ingredient into a patient's bloodstream over the same period. This process is governed by Abbreviated New Drug Applications (ANDAs) filed with the FDA [7]. NDC 17478-0189 has undergone this rigorous approval process.
Pricing Pressures from Payers
- Formulary Placement: Pharmacy Benefit Managers (PBMs) and insurance companies utilize formularies to control costs. Preferred generic drugs are placed on formularies, often at lower tiers, encouraging their use.
- Rebates and Discounts: Manufacturers often offer rebates and discounts to PBMs and payers to secure favorable formulary placement. These negotiations are complex and opaque, influencing net prices significantly [5].
- Government Programs: Medicare and Medicaid have significant purchasing power and implement their own pricing guidelines and preferred drug lists.
Generic Drug Price Erosion
The generic drug market is subject to substantial price erosion. Upon the entry of multiple generic competitors, prices can drop rapidly. This erosion is often exacerbated by:
- Increased Competition: More generic manufacturers entering the market.
- Supply Chain Efficiencies: Manufacturers optimizing production and distribution.
- Payer Demands: Payers aggressively negotiating for lower prices.
The average selling price (ASP) for many generic antibiotics has declined over time. The ASP is a key metric used by Medicare Part B to reimburse physicians for drugs administered in their offices [8].
Price Projections for NDC 17478-0189
Forecasting precise prices for generic pharmaceuticals is challenging due to the dynamic nature of the market, including payer negotiations, competition, and supply chain dynamics. However, based on the current market conditions and historical trends for similar generic antibiotics, the following projections can be made for NDC 17478-0189.
Current Pricing Environment
The market price for amoxicillin-potassium clavulanate oral suspension (250 mg/31.25 mg per 5 mL) is highly variable and depends on the specific supplier, volume purchased, and contract terms. However, it is generally priced at a very competitive level, reflecting the mature generic status.
Estimated Wholesale Acquisition Cost (WAC) Range (per bottle, typically 75mL or 100mL):
- Low End: $2.00 - $4.00
- High End: $6.00 - $10.00
Note: WAC is the manufacturer's list price before any discounts or rebates. Actual net prices are significantly lower.
Data from sources like First Databank (FDB) and RedBook, which track drug pricing, would provide more granular, albeit often subscription-based, data. These sources typically show a trend of declining prices over the past decade for most widely used generics [9].
Factors Influencing Future Pricing
- Manufacturer Competition: The number of active manufacturers producing amoxicillin-potassium clavulanate oral suspension will continue to be a primary driver of price. If new manufacturers enter or existing ones exit, it will impact pricing.
- Raw Material Costs: Fluctuations in the cost of amoxicillin and potassium clavulanate active pharmaceutical ingredients (APIs) can affect manufacturing costs and, consequently, selling prices. However, for established generics, API costs are often optimized through long-term contracts.
- Payer Negotiations and Rebates: The ongoing power of PBMs and payers to negotiate prices and demand rebates will ensure prices remain under pressure. Net prices are expected to remain low.
- Regulatory Changes: Any shifts in FDA policies or government pricing regulations could influence market dynamics, though significant policy changes directly impacting generic pricing are infrequent.
- Demand Stability: While demand for antibiotics is generally stable, significant shifts in infection rates or the emergence of new treatment guidelines could indirectly affect volume and pricing.
- Supply Chain Disruptions: Global supply chain issues, as experienced in recent years, could temporarily lead to price spikes if supply is constrained, but this is unlikely to represent a long-term trend for a well-established generic.
Price Projections (Next 3-5 Years)
Given the factors above, the price trajectory for NDC 17478-0189 is projected to remain stable with a slight downward trend.
- Short-term (1-2 years): Prices are expected to remain relatively stable, with minor fluctuations due to competitive bidding and seasonal demand. The WAC may see a slight decrease of 1-3% annually due to ongoing market optimization.
- Medium-term (3-5 years): The product will continue to face intense generic competition. Further price erosion is anticipated, though at a slower pace than during the initial generic entry phase. Expect an average annual price decline of 2-4% in WAC terms. The net price after rebates and discounts will be considerably lower and less predictable.
Projected WAC Range (per bottle, 75mL or 100mL):
- Current: $2.00 - $10.00
- By Year 3: $1.80 - $9.00
- By Year 5: $1.60 - $8.00
The wide range reflects the variability across different contract tiers and purchasing volumes. The lower end of the WAC range is likely to represent the pricing achieved by large GPOs (Group Purchasing Organizations) and major pharmacy chains securing high volumes.
Key Takeaways
- NDC 17478-0189 represents Amoxicillin-Potassium Clavulanate Oral Suspension (250 mg/31.25 mg per 5 mL), manufactured by Sandoz Inc.
- The product operates within a mature, highly competitive generic antibiotic market.
- All significant patents and exclusivity periods for the originator product have expired, allowing for widespread generic entry.
- Pricing is characterized by intense competition, payer pressure, and substantial rebates, leading to low net prices.
- Future pricing is projected to remain stable to slightly downward, with an anticipated annual WAC decline of 1-4% over the next five years due to ongoing market dynamics.
Frequently Asked Questions
-
What is the primary indication for Amoxicillin-Potassium Clavulanate Oral Suspension? It is used to treat a variety of bacterial infections, including those of the respiratory tract, urinary tract, and skin and soft tissues.
-
Who are the main competitors to Sandoz Inc. for this product? Major generic competitors include Teva Pharmaceuticals, Viatris (Mylan), Aurobindo Pharma, Lupin Pharmaceuticals, and Hikma Pharmaceuticals, among others.
-
How does the generic pricing of antibiotics compare to branded counterparts? Generic antibiotics are significantly less expensive than their branded origins due to the absence of patent protection and the presence of multiple manufacturers driving competition.
-
What factors are most critical in determining the actual selling price of this NDC to a pharmacy or hospital? The most critical factors are the volume of purchase, the specific contract negotiated with the distributor or payer, and the manufacturer's rebate structure.
-
Are there any foreseeable market disruptions that could significantly alter the price of this product? Significant price alterations are unlikely in the short to medium term, barring major global supply chain disruptions or substantial shifts in antibiotic prescribing guidelines or regulatory policy related to generic drug pricing.
Citations
[1] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-ndc-directory
[2] U.S. National Library of Medicine. (n.d.). Amoxicillin and Potassium Clavulanate. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a607049.html
[3] Grand View Research. (2023). Antibiotics Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/antibiotics-market (Note: Specific reports are proprietary and require purchase; this is a general industry descriptor.)
[4] U.S. Food and Drug Administration. (n.d.). Generic Drugs: The FDA's Role. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-fdas-role
[5] Schondelmeyer, S. W., & Newhouse, J. P. (2006). The role of the payer in drug pricing and utilization. Health Affairs, 25(suppl 2), w285-w299.
[6] GlaxoSmithKline. (n.d.). Intellectual Property. (Company IP statements typically detail patent expiry; specific details for Augmentin are publicly available through patent databases like USPTO or WIPO).
[7] U.S. Food and Drug Administration. (n.d.). Generic Drug Approval Process. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drug-approval-process
[8] Centers for Medicare & Medicaid Services. (n.d.). Physician Fee Schedule Lookup Tool. Retrieved from https://www.cms.gov/medicare/physician-fee-schedule/search (Note: ASP information is derived from this and other CMS datasets.)
[9] Multiple Pharmaceutical Data Providers. (Various dates). Drug Pricing Databases. (Examples include First Databank (FDB), Red Book, IQVIA. Access to this data is typically subscription-based and proprietary.)
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