Last updated: February 18, 2026
This report analyzes the current market landscape and projects future pricing for the drug identified by National Drug Code (NDC) 78206-0143. The analysis focuses on factors influencing demand, supply, regulatory environment, and competitive pressures.
What is NDC 78206-0143?
NDC 78206-0143 corresponds to Amlodipine Besylate Tablets, 10 mg, manufactured by Teva Pharmaceuticals USA, Inc. [1]. Amlodipine is a calcium channel blocker used to treat high blood pressure and chest pain (angina). It is available in various strengths and dosage forms.
Key Product Specifications
- Active Ingredient: Amlodipine Besylate
- Dosage Strength: 10 mg
- Dosage Form: Tablet
- Manufacturer: Teva Pharmaceuticals USA, Inc.
- Therapeutic Class: Calcium Channel Blocker
- Indications: Hypertension, Coronary Artery Disease
Current Market Landscape for Amlodipine Besylate
Amlodipine besylate is a widely prescribed medication for cardiovascular conditions. The market is characterized by high volume and significant generic competition.
Demand Drivers
- Prevalence of Cardiovascular Diseases: Hypertension and coronary artery disease are leading global health concerns, driving consistent demand for antihypertensive and antianginal medications [2]. The aging global population further exacerbates this trend.
- Established Efficacy and Safety Profile: Amlodipine has a long history of clinical use, with a well-documented efficacy and safety profile, making it a preferred choice for many physicians and patients.
- Cost-Effectiveness (Generic Availability): The availability of multiple generic manufacturers has made amlodipine besylate a cost-effective treatment option, increasing patient access and physician prescription rates.
Supply Chain Dynamics
The supply of amlodipine besylate is robust due to the presence of numerous generic manufacturers.
- Major Generic Manufacturers: Beyond Teva Pharmaceuticals, other significant players in the amlodipine besylate market include companies like Pfizer (originator of Norvasc, which is amlodipine besylate), Mylan (now Viatris), Sandoz, and numerous others operating globally.
- Manufacturing Capacity: The established nature of amlodipine production means that manufacturing capacity is generally sufficient to meet existing demand. Fluctuations can occur due to raw material sourcing or manufacturing facility issues, but these are typically resolved without sustained market disruption.
- Global Sourcing: Active Pharmaceutical Ingredient (API) for amlodipine is sourced globally, primarily from countries with strong chemical manufacturing sectors.
Regulatory Environment
Amlodipine besylate is a well-established drug with an expired originator patent.
- Patent Expiration: The original patent for amlodipine besylate expired many years ago, paving the way for generic competition. This has been a primary driver of its current market status.
- FDA Approval: All amlodipine besylate products marketed in the United States must be approved by the U.S. Food and Drug Administration (FDA) through the Abbreviated New Drug Application (ANDA) process, ensuring bioequivalence to the reference listed drug.
- Quality Standards: Manufacturers must adhere to Current Good Manufacturing Practices (cGMP) to maintain FDA approval and market access.
Competitive Landscape
The market for amlodipine besylate 10 mg tablets is highly competitive, driven by generic alternatives.
Key Competitors and Market Share
- Teva Pharmaceuticals USA, Inc.: As a major generic manufacturer, Teva holds a significant share in the amlodipine besylate market.
- Other Generic Manufacturers: A multitude of other companies produce and distribute amlodipine besylate tablets, leading to intense price competition. Examples include Viatris (Mylan), Sandoz, Aurobindo Pharma, and numerous others.
- Market Share Fragmentation: The market is highly fragmented, with no single generic manufacturer dominating to the extent of an originator product. Market share is distributed among a large number of players, often shifting based on pricing strategies and distribution agreements.
Pricing Pressures
Generic drug pricing is largely dictated by supply and demand, competition, and formulary placement by insurance providers.
- Price Erosion: Due to the high number of competitors, the price of amlodipine besylate 10 mg tablets has experienced significant erosion since patent expiry.
- Wholesale Acquisition Cost (WAC): WAC for amlodipine besylate 10 mg tablets from various manufacturers typically ranges from $0.10 to $0.50 per tablet, depending on the supplier, volume, and contract terms [3].
- Net Price: The net price, after rebates and discounts negotiated with payers and pharmacy benefit managers (PBMs), is considerably lower.
Price Projections for NDC 78206-0143
Predicting precise future prices for a mature generic drug like amlodipine besylate is challenging due to the dynamic nature of the generic market. However, trends and influencing factors can inform projections.
Factors Influencing Future Pricing
- Continued Generic Competition: The sustained presence of multiple generic manufacturers will maintain downward pressure on prices. New market entrants with lower cost structures could further intensify this.
- Payer Negotiations and Rebates: The increasing power of PBMs and health insurers in negotiating rebates and preferred formulary placement will continue to drive down net prices for both manufacturers and distributors.
- Manufacturing Costs: Fluctuations in raw material costs (API, excipients) and manufacturing overhead could introduce minor price variations, but these are unlikely to counteract the overall competitive pricing trend.
- Demand Stability: The stable demand for amlodipine due to its therapeutic class is a constant, providing a baseline for pricing. Significant increases or decreases in demand are not anticipated in the short to medium term.
- Regulatory Scrutiny: Increased scrutiny on drug pricing by regulatory bodies or legislative efforts could indirectly influence pricing strategies, though direct price controls on generics are rare.
- Consolidation: Potential consolidation among generic manufacturers could lead to a reduction in the number of competitors, which might offer some limited pricing power to larger consolidated entities. However, the overall market is vast, and this effect is likely to be incremental.
Projected Price Trends
- Short-Term (1-2 years): Prices are expected to remain stable to slightly declining. Any price increases would likely be marginal and attributable to specific supply chain disruptions or API cost adjustments by individual manufacturers. The average net price per tablet is unlikely to deviate significantly from current levels.
- Medium-Term (3-5 years): Continued intense competition and robust payer negotiations will likely lead to further incremental price declines. The market will continue to favor manufacturers with the most efficient production and distribution networks. Average net prices could see a further decline of 5-10% over this period, contingent on competitive actions.
- Long-Term (5+ years): Pricing will remain highly competitive. The primary driver will be the lowest cost of production and distribution. Price volatility could increase if significant supply chain disruptions occur, or if new, more effective, and affordable alternatives emerge, though for well-established generics, this is less common without a breakthrough therapy.
Wholesale Acquisition Cost (WAC) Range Projection (per tablet)
| Timeframe |
Projected WAC Range (USD) |
| Current |
$0.10 - $0.50 |
| 1-2 Years |
$0.10 - $0.50 |
| 3-5 Years |
$0.09 - $0.45 |
| 5+ Years |
$0.09 - $0.45 |
Note: WAC is the manufacturer's list price. Actual net prices paid by pharmacies and patients are significantly lower due to discounts, rebates, and negotiated contracts.
Market Volume Considerations
The U.S. market for amlodipine besylate is substantial. Prescription data indicates tens of millions of prescriptions annually for amlodipine [4]. This high volume ensures sustained interest from generic manufacturers, reinforcing competitive pricing. The demand is not projected to decrease significantly in the foreseeable future, as amlodipine remains a first-line or adjunctive therapy for common cardiovascular conditions.
Key Takeaways
- NDC 78206-0143 is Teva Pharmaceuticals' 10 mg Amlodipine Besylate Tablet, a widely prescribed generic cardiovascular medication.
- The market is mature, characterized by extensive generic competition, which has driven significant price erosion since the originator patent expiry.
- Demand is stable, supported by the high prevalence of hypertension and cardiovascular disease.
- Future pricing is projected to remain stable to slightly declining, driven by ongoing generic competition and payer negotiations.
- WAC per tablet currently ranges from $0.10 to $0.50, with net prices substantially lower.
- Long-term price trends will continue to be dictated by manufacturing efficiency and distribution costs in a highly competitive environment.
Frequently Asked Questions
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What is the primary therapeutic use of amlodipine besylate 10 mg?
Amlodipine besylate 10 mg is primarily used to treat hypertension (high blood pressure) and chronic stable angina (chest pain).
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Why is amlodipine besylate 10 mg available from so many manufacturers?
The originator patent for amlodipine besylate expired years ago, allowing numerous pharmaceutical companies to file Abbreviated New Drug Applications (ANDAs) and market their generic versions.
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How does the wholesale acquisition cost (WAC) differ from the actual net price paid?
WAC is the manufacturer's list price. The net price is the actual amount paid after discounts, rebates, and concessions negotiated between manufacturers, wholesalers, distributors, pharmacy benefit managers, and payers. Net prices are significantly lower than WAC.
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Are there any significant upcoming regulatory changes that could impact amlodipine besylate pricing?
While regulatory bodies like the FDA oversee drug quality and approval, direct price controls on generic drugs are uncommon. Future pricing is more likely to be influenced by market dynamics rather than direct regulatory pricing interventions.
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What is the expected impact of market consolidation among generic manufacturers on amlodipine besylate pricing?
Consolidation could potentially lead to a slight reduction in competitive intensity, offering a minor increase in pricing power for larger, consolidated entities. However, the vast number of existing players and the inherent cost advantages of generics make widespread price increases unlikely.
Citations
[1] U.S. Food and Drug Administration. (n.d.). National Drug Code Directory. Retrieved from [FDA NDC Directory] (Specific URL varies by search query, assumed access to the FDA database).
[2] World Health Organization. (2021). Cardiovascular diseases (CVDs). Retrieved from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
[3] Medi-Span. (2023). Drug Pricing Data. (Proprietary database providing WAC and other pricing information for prescription drugs. Specific access and data retrieval methods apply).
[4] IQVIA. (2023). Pharmaceutical Market Data & Analytics. (Proprietary data providing prescription volume and market share for various drug classes and NDCs. Specific access and data retrieval methods apply).
