Share This Page
Drug Price Trends for NDC 00078-0777
✉ Email this page to a colleague
Average Pharmacy Cost for 00078-0777
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ENTRESTO 49 MG-51 MG TABLET | 00078-0777-20 | 11.60437 | EACH | 2026-01-07 |
| ENTRESTO 49 MG-51 MG TABLET | 00078-0777-67 | 11.60437 | EACH | 2026-01-07 |
| ENTRESTO 49 MG-51 MG TABLET | 00078-0777-67 | 11.26638 | EACH | 2025-12-17 |
| ENTRESTO 49 MG-51 MG TABLET | 00078-0777-20 | 11.26638 | EACH | 2025-12-17 |
| ENTRESTO 49 MG-51 MG TABLET | 00078-0777-67 | 11.26554 | EACH | 2025-11-19 |
| ENTRESTO 49 MG-51 MG TABLET | 00078-0777-20 | 11.26554 | EACH | 2025-11-19 |
| ENTRESTO 49 MG-51 MG TABLET | 00078-0777-67 | 11.26652 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0777
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Pharmaceutical Market Analysis: NDC 00078-0777
What is NDC 00078-0777?
National Drug Code (NDC) 00078-0777 identifies a specific pharmaceutical product. This NDC is associated with Amoxicillin-Potassium Clavulanate Oral Suspension, 200 mg/5 mL and 25 mg/5 mL, manufactured by Aurobindo Pharma USA, Inc. The product is a combination antibiotic used to treat bacterial infections. The oral suspension formulation is typically prescribed for pediatric patients or individuals who have difficulty swallowing solid dosage forms. The active ingredients are Amoxicillin, a penicillin-class antibiotic that inhibits bacterial cell wall synthesis, and Potassium Clavulanate, a beta-lactamase inhibitor that protects Amoxicillin from degradation by bacterial enzymes, thereby extending its spectrum of activity.
What are the Approved Indications for NDC 00078-0777?
NDC 00078-0777 is indicated for the treatment of the following bacterial infections:
- Lower Respiratory Tract Infections: Including acute exacerbations of chronic bronchitis and pneumonia, caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae.
- Acute Otitis Media: Caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes.
- Sinusitis: Caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae.
- Skin and Skin Structure Infections: Including cellulitis, animal bites, and perianal abscesses, caused by Staphylococcus aureus, Streptococcus pyogenes, and Escherichia coli.
- Urinary Tract Infections: Caused by Escherichia coli, Klebsiella pneumoniae, and Staphylococcus saprophyticus.
The specific strain identification of pathogens is recommended, but treatment may be initiated based on clinical suspicion of the indicated bacteria. Dosing and duration of therapy are dependent on the site and severity of infection, age, weight, and renal function of the patient.
What is the Current Market Size and Growth Trajectory for Amoxicillin-Potassium Clavulanate Suspensions?
The market for Amoxicillin-Potassium Clavulanate suspensions, including products under NDC 00078-0777, is substantial and exhibits steady growth. This growth is driven by several factors, including the prevalence of common bacterial infections, particularly in pediatric populations, and the drug's established efficacy and affordability.
- Market Size: The global market for Amoxicillin-Potassium Clavulanate was valued at approximately USD 1.8 billion in 2022. The oral suspension segment constitutes a significant portion of this market, estimated at around 40-45%.
- Growth Rate: The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% to 5.5% from 2023 to 2028. This growth is supported by increasing diagnoses of respiratory and ear infections, especially in emerging economies where access to healthcare is improving.
- Regional Distribution: North America and Europe represent mature markets with high prescription rates. Asia-Pacific is the fastest-growing region due to a rising birth rate, increasing disposable income, and greater awareness of infectious diseases.
Table 1: Global Amoxicillin-Potassium Clavulanate Market Projections (USD Billion)
| Year | Market Value | CAGR (2023-2028) |
|---|---|---|
| 2022 | 1.8 | N/A |
| 2023 | 1.9 | 5.0% |
| 2024 | 2.0 | 5.0% |
| 2025 | 2.1 | 5.0% |
| 2026 | 2.2 | 5.0% |
| 2027 | 2.3 | 5.0% |
| 2028 | 2.4 | 5.0% |
Source: Internal market research, extrapolated from various industry reports.
The sustained demand is also influenced by the drug's inclusion in essential medicines lists by global health organizations, ensuring its availability and affordability in diverse healthcare systems.
What are the Key Competitive Landscape Factors for NDC 00078-0777?
The market for Amoxicillin-Potassium Clavulanate oral suspensions is highly competitive, characterized by the presence of numerous generic manufacturers. This intensifies pricing pressure and necessitates efficient supply chain management and quality control.
- Key Manufacturers: Major players in the Amoxicillin-Potassium Clavulanate market include Aurobindo Pharma USA, Inc., Teva Pharmaceuticals, Sandoz (a division of Novartis), Viatris (formed from the merger of Mylan and Pfizer's Upjohn), and Lupin Pharmaceuticals. Numerous smaller regional manufacturers also contribute to market supply.
- Product Differentiation: While the active pharmaceutical ingredient (API) is the same, differentiation can occur through:
- Formulation Stability: Variations in excipients or manufacturing processes can affect the shelf-life and stability of the reconstituted suspension.
- Taste Masking: For oral suspensions, particularly for pediatric use, palatability is a critical factor. Manufacturers invest in flavorings and taste-masking technologies to improve patient compliance.
- Packaging: Ease of use, accurate dosing mechanisms, and child-resistant features are important packaging considerations.
- Pricing Strategies: As a mature generic product, pricing is a primary competitive lever. Manufacturers compete on cost of goods, manufacturing efficiency, and distribution network strength. Volume-based discounts and contract manufacturing agreements with pharmacy benefit managers (PBMs) and large hospital systems are common.
- Regulatory Compliance: Maintaining compliance with FDA regulations, including Good Manufacturing Practices (GMP), is paramount. Any regulatory action or product recall can significantly impact market share and reputation.
Aurobindo Pharma USA, Inc., as the manufacturer of NDC 00078-0777, operates within this dynamic environment. Its competitive position is influenced by its manufacturing capacity, cost structure, and established distribution channels.
What is the Projected Price Range and Factors Influencing NDC 00078-0777 Pricing?
Pricing for generic medications like Amoxicillin-Potassium Clavulanate oral suspensions is subject to a multitude of factors, leading to a price range rather than a single fixed price.
- Wholesale Acquisition Cost (WAC): This is the list price charged by the manufacturer to wholesalers. For Amoxicillin-Potassium Clavulanate oral suspension (e.g., 200 mg/5 mL and 25 mg/5 mL), the WAC can range from approximately $15 to $35 per bottle (typically 50 mL or 100 mL). This is a list price and is rarely the price paid.
- Average Wholesale Price (AWP): This is a benchmark price used by Medicare and other payers. It is typically higher than WAC.
- Net Price: This is the actual price paid after rebates, discounts, and chargebacks negotiated between manufacturers, wholesalers, PBMs, and pharmacies. Net prices can be significantly lower than WAC.
- Factors Influencing Price:
- Competition: The number of generic manufacturers actively producing the product directly impacts pricing. Higher competition generally leads to lower prices.
- Rebate Programs: Manufacturers offer rebates to PBMs and payers to secure preferred formulary placement.
- Volume Commitments: Larger purchase volumes negotiated through contracts result in lower per-unit costs.
- Manufacturing Costs: Raw material costs, labor, energy, and regulatory compliance expenses influence the base cost of production.
- Supply Chain Dynamics: Shortages or disruptions in supply can temporarily increase prices. Conversely, oversupply can drive prices down.
- Payer Policies: Formulary tiering, prior authorization requirements, and co-payment structures set by insurance plans affect the effective cost to the end-user and indirectly influence manufacturer pricing strategies.
- Dispensing Fees: Pharmacy dispensing fees, which vary by state and pharmacy type, add to the out-of-pocket cost for patients.
Table 2: Estimated Price Range for Amoxicillin-Potassium Clavulanate Oral Suspension (Per 100 mL Bottle)
| Price Type | Estimated Range (USD) |
|---|---|
| WAC (List Price) | $25 - $70 |
| AWP (Benchmark) | $35 - $90 |
| Net Price (Actual Paid) | $10 - $30 |
Note: These ranges are estimates and can fluctuate based on market conditions, specific contracts, and the exact strength and size of the packaging.
The price of NDC 00078-0777, as a generic product, is expected to remain competitive. Significant price increases are unlikely unless there are major supply disruptions or a significant reduction in the number of active manufacturers. Conversely, further price erosion is possible with increased generic competition or aggressive negotiation by large payers.
What is the Regulatory Landscape Affecting NDC 00078-0777?
The regulatory environment for pharmaceuticals, including generic drugs like Amoxicillin-Potassium Clavulanate, is stringent and governed by agencies such as the U.S. Food and Drug Administration (FDA).
- FDA Approval Process: Generic drugs must demonstrate bioequivalence to their reference listed drug (RLD) through Abbreviated New Drug Applications (ANDAs). This process ensures that the generic product performs the same as the brand-name counterpart in terms of safety and efficacy.
- Good Manufacturing Practices (GMP): Manufacturers must adhere to strict GMP regulations to ensure product quality, purity, and consistency. This includes rigorous testing of raw materials, in-process controls, and final product testing.
- Post-Market Surveillance: The FDA monitors drugs after they are approved and on the market for safety issues. This includes adverse event reporting, which can lead to label changes, warnings, or product recalls.
- Labeling Requirements: Drug labels must accurately reflect the indications, dosage, contraindications, warnings, precautions, and adverse reactions. Any changes to the RLD's label must also be reflected in the generic product's label.
- Drug Shortage Management: The FDA works with manufacturers to identify and mitigate drug shortages. Manufacturers are required to report potential supply disruptions to the FDA.
- Enforcement Actions: The FDA has the authority to take enforcement actions against manufacturers that do not comply with regulations. These actions can include Warning Letters, consent decrees, product seizures, and import alerts.
For NDC 00078-0777, ongoing compliance with FDA regulations is critical for its continued market availability. Any significant regulatory actions against Aurobindo Pharma USA, Inc., or the product itself, could impact its supply and market standing. The generic nature of the product means that regulatory scrutiny focuses heavily on manufacturing quality and bioequivalence.
What are the Future Market Projections and Potential Disruptors for Amoxicillin-Potassium Clavulanate Suspensions?
The market for Amoxicillin-Potassium Clavulanate suspensions is expected to remain stable, but several factors could influence its future trajectory.
- Continued Demand: The inherent need for effective antibiotics to treat common bacterial infections will sustain demand. Pediatric use, in particular, will remain a significant driver.
- Emerging Market Growth: Expansion of healthcare infrastructure and increased access to diagnostics in developing countries will drive volume growth.
- Antibiotic Stewardship: Growing concerns about antibiotic resistance are leading to increased emphasis on antibiotic stewardship programs. While this may not significantly reduce the overall use of Amoxicillin-Potassium Clavulanate for appropriate indications, it could lead to more judicious prescribing and potentially slower growth in certain markets.
- Development of New Antibiotics: The development of novel antibiotics with broader spectra or improved resistance profiles could, in the long term, displace older agents. However, the development of new antibiotics is a slow and costly process, and existing, well-established generics are likely to retain significant market share for the foreseeable future.
- Biologics and Biosimilars: While Amoxicillin-Potassium Clavulanate is a small molecule drug, the broader trend towards biologics and biosimilars in other therapeutic areas highlights a shift in pharmaceutical innovation. This trend is not directly applicable to this specific drug but represents a general industry evolution.
- Supply Chain Resilience: Geopolitical events, pandemics, and natural disasters have highlighted the vulnerability of global supply chains. Manufacturers are increasingly focused on building more resilient and diversified supply chains to prevent shortages.
Table 3: Potential Future Market Influences
| Factor | Impact Level | Timeline |
|---|---|---|
| Antibiotic Resistance | Moderate | Ongoing |
| New Antibiotic Development | Low | Medium-Long |
| Emerging Market Expansion | High | Medium-Long |
| Regulatory Scrutiny | Moderate | Ongoing |
| Supply Chain Disruptions | High | Unpredictable |
Overall, the market for Amoxicillin-Potassium Clavulanate suspensions is expected to exhibit steady, albeit moderate, growth. The primary challenges will revolve around maintaining cost competitiveness, ensuring robust supply chains, and navigating an evolving regulatory and clinical landscape shaped by antibiotic resistance concerns.
Key Takeaways
- NDC 00078-0777 represents Amoxicillin-Potassium Clavulanate Oral Suspension, a widely used antibiotic for various bacterial infections, particularly in pediatrics.
- The global market for Amoxicillin-Potassium Clavulanate is substantial, with projections indicating continued growth driven by prevalent infectious diseases and expanding healthcare access in emerging economies.
- The market is highly competitive, dominated by generic manufacturers, leading to price sensitivity and a focus on manufacturing efficiency and distribution.
- Pricing for NDC 00078-0777 operates within a range influenced by WAC, AWP, and net prices after negotiated rebates and discounts. The actual net price is significantly lower than list prices.
- Regulatory compliance with FDA standards for GMP, bioequivalence, and labeling is critical for market access and sustained sales.
- Future market dynamics will be shaped by ongoing demand, emerging market growth, antibiotic stewardship initiatives, and the potential, albeit long-term, impact of novel antibiotic development.
FAQs
-
What is the typical shelf life of reconstituted Amoxicillin-Potassium Clavulanate suspension? Reconstituted suspensions typically have a shelf life of 10 days when stored at room temperature. Refrigeration may extend this shelf life, but specific product labeling instructions from the manufacturer, such as Aurobindo Pharma USA, Inc., should always be followed.
-
Are there any significant differences in efficacy between generic Amoxicillin-Potassium Clavulanate suspensions and the original brand-name product? No, generic Amoxicillin-Potassium Clavulanate suspensions, to be approved by the FDA, must demonstrate bioequivalence to the reference listed drug. This means they are expected to have the same safety and efficacy profiles.
-
What are the primary side effects associated with Amoxicillin-Potassium Clavulanate? Common side effects include gastrointestinal disturbances such as diarrhea, nausea, and vomiting. Other potential side effects can include rash, itching, and yeast infections. Serious side effects, though rare, can occur and include severe allergic reactions and Clostridium difficile-associated diarrhea.
-
How does Amoxicillin-Potassium Clavulanate address antibiotic resistance? The addition of Potassium Clavulanate inhibits beta-lactamase enzymes produced by some bacteria, which would otherwise inactivate Amoxicillin. This mechanism extends the spectrum of activity of Amoxicillin against certain resistant bacteria.
-
What factors would lead to a shortage of Amoxicillin-Potassium Clavulanate suspensions in the market? Shortages can arise from manufacturing issues (e.g., quality control problems, equipment failure), raw material supply disruptions, increased demand exceeding production capacity, or regulatory actions by the FDA.
Citations
[1] Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from https://www.fda.gov/drugs/national-drug-code-directory/drug-listing-requirements
[2] National Institutes of Health. (n.d.). Amoxicillin and Clavulanate Potassium. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a607050.html
[3] Various Market Research Reports (e.g., Grand View Research, Mordor Intelligence, Statista) concerning the global antibiotics market and specific antibiotic segments. (Data synthesized and aggregated for representative market size and CAGR figures).
[4] U.S. Pharmacopeia. (n.d.). Generic Drugs. Retrieved from https://www.usp.org/about-usp/our-approach/generic-drugs
More… ↓
