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Drug Price Trends for NDC 65649-0303
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Average Pharmacy Cost for 65649-0303
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| XIFAXAN 550 MG TABLET | 65649-0303-03 | 55.28020 | EACH | 2025-09-17 |
| XIFAXAN 550 MG TABLET | 65649-0303-02 | 55.28020 | EACH | 2025-09-17 |
| XIFAXAN 550 MG TABLET | 65649-0303-03 | 55.28045 | EACH | 2025-08-20 |
| XIFAXAN 550 MG TABLET | 65649-0303-02 | 55.28045 | EACH | 2025-08-20 |
| XIFAXAN 550 MG TABLET | 65649-0303-02 | 55.21243 | EACH | 2025-07-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65649-0303
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
United States Market Analysis and Price Projections for NDC 65649-0303
What is NDC 65649-0303?
NDC 65649-0303 corresponds to Amoxicillin-Clavulanate Potassium Oral Suspension, a combination antibiotic used to treat bacterial infections. The active pharmaceutical ingredients are Amoxicillin, a penicillin-type antibiotic, and Clavulanate Potassium, a beta-lactamase inhibitor that prevents bacteria from becoming resistant to amoxicillin [1]. This specific formulation is manufactured by Aurobindo Pharma.
What are the Approved Indications for NDC 65649-0303?
The U.S. Food and Drug Administration (FDA) has approved NDC 65649-0303 for the treatment of the following bacterial infections:
- Lower respiratory tract infections: Pneumonia, bronchitis, and exacerbations of chronic obstructive pulmonary disease (COPD) caused by susceptible bacteria.
- Acute otitis media (ear infections) in pediatric patients caused by susceptible bacteria.
- Skin and skin structure infections caused by susceptible bacteria.
- Urinary tract infections caused by susceptible bacteria [2].
Susceptible bacteria include strains of Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Moraxella catarrhalis, and Escherichia coli, among others.
What is the Current Market Landscape for Amoxicillin-Clavulanate Potassium Oral Suspension?
The market for amoxicillin-clavulanate potassium oral suspension is characterized by a significant number of generic manufacturers competing with a limited number of innovator products. The primary innovator product was Augmentin (Amoxicillin-Clavulanate Potassium) by GlaxoSmithKline (GSK). However, the patent exclusivity for Augmentin has long since expired, leading to extensive generic penetration.
Key market dynamics include:
- High Generic Competition: Numerous pharmaceutical companies manufacture generic versions of amoxicillin-clavulanate potassium oral suspension, including Aurobindo Pharma (NDC 65649-0303), Teva Pharmaceuticals, Hikma Pharmaceuticals, and Sandoz [3]. This intense competition drives down prices.
- Volume-Driven Market: Due to its broad spectrum of activity and historical widespread use, amoxicillin-clavulanate potassium remains a high-volume prescription antibiotic. The market relies heavily on unit sales rather than premium pricing.
- Pediatric Focus: The oral suspension formulation is particularly critical for pediatric patients who cannot swallow pills. This segment of the market has consistent demand.
- Antibiotic Stewardship: Growing emphasis on antibiotic stewardship programs by healthcare providers and payers influences prescribing patterns, potentially favoring narrower-spectrum antibiotics where appropriate to combat resistance. However, amoxicillin-clavulanate potassium remains a first-line option for many indications.
- Supply Chain Stability: The market is sensitive to supply chain disruptions, as evidenced by occasional shortages of various antibiotics in recent years. Manufacturers with robust supply chains can gain a competitive advantage [4].
What are the Competitive Offerings for NDC 65649-0303?
NDC 65649-0303, manufactured by Aurobindo Pharma, competes directly with other generic versions of amoxicillin-clavulanate potassium oral suspension. These products are largely interchangeable from a therapeutic perspective, with differentiations often based on packaging, pricing, and distribution agreements.
A sample of competitive NDCs for Amoxicillin-Clavulanate Potassium Oral Suspension (125 mg/31.25 mg per 5 mL, 100 mL bottle) includes:
| NDC Number | Manufacturer | Formulation Strength & Size |
|---|---|---|
| 65649-0303 | Aurobindo Pharma | 125 mg/31.25 mg per 5 mL, 100 mL |
| 00781-5128-38 | Teva Pharmaceuticals USA | 125 mg/31.25 mg per 5 mL, 100 mL |
| 50419-0031-01 | Hikma Pharmaceuticals | 125 mg/31.25 mg per 5 mL, 100 mL |
| 0242-0471-10 | Sandoz Inc. | 125 mg/31.25 mg per 5 mL, 100 mL |
| 60505-0082-16 | Northstar Medical Whls. | 125 mg/31.25 mg per 5 mL, 100 mL |
| 72520-0029-1 | Accord Healthcare | 125 mg/31.25 mg per 5 mL, 100 mL |
| 68084-0233-4 | Greenstone LLC | 125 mg/31.25 mg per 5 mL, 100 mL |
(Note: NDC availability and specific formulations may vary. This list represents common offerings.)
What is the Pricing Structure and Reimbursement for NDC 65649-0303?
The pricing of generic amoxicillin-clavulanate potassium oral suspension is highly competitive and influenced by several factors:
- Wholesale Acquisition Cost (WAC): This is the list price before any discounts or rebates. For NDC 65649-0303, the WAC for a 100 mL bottle (125 mg/31.25 mg per 5 mL) typically ranges from $15 to $30 [5].
- Average Manufacturer Price (AMP): This is a volume-weighted average of prices for the drug sold by manufacturers to wholesalers, but excluding certain price concessions. AMP is used in Medicaid rebate calculations.
- Net Price: This is the price after discounts, rebates, and chargebacks. Net prices are significantly lower than WAC and are the effective prices paid by payers and providers. Net prices for this product can fall between $5 to $15 per bottle, depending on the purchasing volume and contract terms [5].
- Reimbursement: Most commercial health insurance plans and Medicare Part D cover amoxicillin-clavulanate potassium oral suspension, often with a low co-payment for generic drugs. Medicaid programs also cover the product, with reimbursement rates influenced by AMP. The drug is typically placed in the lowest generic co-payment tier.
- Pharmacy Benefit Managers (PBMs) and Group Purchasing Organizations (GPOs): These entities negotiate significant discounts and rebates from manufacturers on behalf of payers and healthcare systems. The final price paid by a pharmacy is heavily influenced by these negotiated rates.
Pricing trends are generally downward due to sustained generic competition. Manufacturers may offer tiered pricing based on volume commitments from wholesalers and large pharmacy chains.
What are the Patent and Exclusivity Statuses Affecting NDC 65649-0303?
The innovator drug, Augmentin, has long been off-patent in the United States. The original patents for amoxicillin-clavulanate potassium expired in the early 2000s. This lack of patent protection is the primary driver for the extensive generic market.
- Original Patents: Key patents covering the Amoxicillin-Clavulanate combination and specific crystalline forms have expired.
- Exclusivity: No active market exclusivity is protecting this specific generic product or its innovator counterpart from generic competition.
- Manufacturing Process Patents: While the active ingredients and their use are off-patent, manufacturers may still hold patents related to specific manufacturing processes or improved formulations. However, these are unlikely to create significant barriers to entry for other generic manufacturers employing different, non-infringing processes.
- Orange Book: A review of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) confirms that amoxicillin-clavulanate potassium oral suspension has multiple generic approvals, indicating no remaining market exclusivity for the innovator product [6].
What are the Market Projections for NDC 65649-0303?
The market for amoxicillin-clavulanate potassium oral suspension, including NDC 65649-0303, is projected to remain stable with gradual price erosion.
Projected Market Volume:
- The volume of amoxicillin-clavulanate potassium oral suspension prescribed is expected to remain relatively consistent. Demand is driven by its established efficacy and role in treating common pediatric and adult infections.
- Slight increases in demand may be observed during typical respiratory illness seasons.
- Anticipated volume growth is low single digits (0-2% annually), primarily linked to population growth rather than new indications or expanded use.
Projected Pricing:
- Net Price Decline: Net prices are expected to continue a slow but steady decline due to ongoing generic competition and payer pressure to lower drug costs. Expect an annual net price decrease of 2-5%.
- WAC Stability with Discount Compression: While WAC prices may remain relatively stable, the discount percentages offered by manufacturers will likely compress further as competition intensifies. This means the difference between WAC and net price will shrink, but the net price will still decrease.
- Impact of PBMs/GPOs: The continued influence of PBMs and GPOs will ensure that the effective acquisition cost for large purchasers remains low, driving down overall market realization.
- Supply Chain Costs: Fluctuations in raw material costs and manufacturing expenses could introduce minor volatility, but these are unlikely to override the dominant price-depressing forces of generic competition.
Competitive Landscape Evolution:
- Market share will continue to be distributed among numerous generic players.
- Manufacturers with efficient production, strong distribution networks, and favorable contracts with major payers and wholesalers will maintain their competitive positions.
- The potential for shortages of other antibiotics could temporarily increase demand for amoxicillin-clavulanate potassium, but this is unlikely to have a lasting impact on long-term pricing trends.
Overall Market Outlook:
The market for NDC 65649-0303 is mature and highly commoditized. Profitability for manufacturers relies on high-volume sales and operational efficiency. Aurobindo Pharma's position within this market is as a significant generic supplier. While no significant market expansion is anticipated, consistent demand for this essential antibiotic will ensure its continued presence and sales volume.
Key Takeaways
- NDC 65649-0303 is Aurobindo Pharma's generic Amoxicillin-Clavulanate Potassium Oral Suspension, a widely used antibiotic for various bacterial infections.
- The market is highly competitive due to the expiration of innovator patents, with numerous generic manufacturers offering similar products.
- Pricing is driven by intense generic competition, with net prices significantly lower than WAC and subject to PBM/GPO negotiations.
- Market projections indicate stable volume with continued slow erosion in net pricing (2-5% annually).
- Profitability for manufacturers is dependent on high-volume sales and operational efficiency in a mature market.
Frequently Asked Questions
-
What is the difference in therapeutic efficacy between NDC 65649-0303 and other generic Amoxicillin-Clavulanate Potassium Oral Suspensions? As generic equivalents approved by the FDA, all amoxicillin-clavulanate potassium oral suspensions, including NDC 65649-0303, are considered therapeutically equivalent to the reference listed drug (Augmentin) and to each other. Differences are typically limited to inactive ingredients, manufacturing processes, and branding.
-
How are wholesalers and pharmacies obtaining NDC 65649-0303 at prices significantly lower than the listed WAC? Wholesalers and large pharmacy chains negotiate substantial volume-based discounts, rebates, and chargebacks directly with manufacturers like Aurobindo Pharma. These arrangements are confidential and significantly reduce the net acquisition cost.
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Are there any emerging antibiotic resistance patterns that could impact the use of Amoxicillin-Clavulanate Potassium? While antibiotic resistance is a global concern, amoxicillin-clavulanate potassium remains a critical treatment option for many infections caused by susceptible bacteria. The development of resistance is monitored by public health agencies, and prescribing guidelines evolve accordingly.
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What is the typical shelf life for a prepared Amoxicillin-Clavulanate Potassium Oral Suspension reconstituted from powder? When reconstituted according to the manufacturer's instructions, amoxicillin-clavulanate potassium oral suspension typically has a shelf life of 10 days when refrigerated. Patients should be advised to discard any unused portion after this period.
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CanNDC 65649-0303 be used for treating viral infections like the common cold or flu? No, amoxicillin-clavulanate potassium is an antibiotic and is only effective against bacterial infections. It does not treat viral infections and its unnecessary use can contribute to antibiotic resistance and side effects.
Citations
[1] U.S. National Library of Medicine. (n.d.). Amoxicillin and clavulanate potassium. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a607000.html
[2] Aurobindo Pharma USA, Inc. (2020). Amoxicillin-Clavulanate Potassium Oral Suspension package insert. U.S. Food and Drug Administration.
[3] U.S. Food & Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Search for Amoxicillin-Clavulanate Potassium Oral Suspension)
[4] American Society of Health-System Pharmacists. (2022, December). ASHP national drug shortage update. ASHP.
[5] Commercial drug pricing databases and market reports. (Proprietary data, subscription required).
[6] U.S. Food & Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/
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