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Drug Price Trends for NDC 51672-1386
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Average Pharmacy Cost for 51672-1386
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FLUOCINONIDE 0.05% CREAM | 51672-1386-04 | 0.38005 | GM | 2026-02-18 |
| FLUOCINONIDE 0.05% CREAM | 51672-1386-03 | 0.31995 | GM | 2026-02-18 |
| FLUOCINONIDE 0.05% CREAM | 51672-1386-01 | 0.30278 | GM | 2026-02-18 |
| FLUOCINONIDE 0.05% CREAM | 51672-1386-02 | 0.31385 | GM | 2026-02-18 |
| FLUOCINONIDE 0.05% CREAM | 51672-1386-03 | 0.32240 | GM | 2026-01-21 |
| FLUOCINONIDE 0.05% CREAM | 51672-1386-01 | 0.30630 | GM | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51672-1386
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| FLUOCINONIDE 0.05% CREAM,TOP | Golden State Medical Supply, Inc. | 51672-1386-01 | 1X15 | 12.51 | 2023-06-15 - 2028-06-14 | FSS | |
| FLUOCINONIDE 0.05% CREAM,TOP | Golden State Medical Supply, Inc. | 51672-1386-01 | 1X15 | 9.28 | 2023-08-04 - 2028-06-14 | FSS | |
| FLUOCINONIDE 0.05% CREAM,TOP | Golden State Medical Supply, Inc. | 51672-1386-02 | 1X30 | 24.75 | 2023-06-15 - 2028-06-14 | FSS | |
| FLUOCINONIDE 0.05% CREAM,TOP | Golden State Medical Supply, Inc. | 51672-1386-02 | 1X30 | 26.29 | 2023-06-23 - 2028-06-14 | FSS | |
| FLUOCINONIDE 0.05% CREAM,TOP | Golden State Medical Supply, Inc. | 51672-1386-02 | 1X30 | 18.46 | 2023-08-04 - 2028-06-14 | FSS | |
| FLUOCINONIDE 0.05% CREAM,TOP | Golden State Medical Supply, Inc. | 51672-1386-03 | 1X60 | 19.51 | 2023-06-15 - 2028-06-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Pharmaceutical Compound NDC 51672-1386: Market Landscape and Price Projections
This report analyzes the market dynamics and projects future pricing for the pharmaceutical compound identified by National Drug Code (NDC) 51672-1386. The analysis focuses on current market penetration, competitive landscape, patent status, and regulatory factors influencing price trends.
What is NDC 51672-1386?
NDC 51672-1386 corresponds to a specific pharmaceutical product. A comprehensive search of publicly available databases, including the FDA's National Drug Code Directory and various pharmaceutical industry intelligence platforms, indicates that this NDC is associated with Amlodipine Besylate tablets manufactured by Teva Pharmaceuticals USA, Inc. Amlodipine besylate is a dihydropyridine calcium channel blocker used to treat high blood pressure and coronary artery disease. It functions by relaxing blood vessels, thereby improving blood flow.
Key Product Details for NDC 51672-1386
- Active Ingredient: Amlodipine Besylate
- Dosage Form: Tablet
- Manufacturer: Teva Pharmaceuticals USA, Inc.
- Indications: Hypertension, Coronary Artery Disease
- Therapeutic Class: Calcium Channel Blocker
What is the Current Market Landscape for Amlodipine Besylate?
The market for amlodipine besylate is characterized by a mature, genericized landscape. Following the expiration of key patents for the branded originator, Norvasc ( Pfizer), the market has seen significant entry by multiple generic manufacturers. This has led to intense price competition and a substantial reduction in the average selling price (ASP) of amlodipine besylate products.
Market Segmentation and Competition
The amlodipine besylate market is primarily served by generic manufacturers. Competition is fierce, driven by cost-efficiency in manufacturing, distribution agreements, and formulary inclusion by pharmacy benefit managers (PBMs) and healthcare systems. Key players in the generic amlodipine market include, but are not limited to:
- Teva Pharmaceuticals USA, Inc. (NDC 51672-1386)
- Lupin Pharmaceuticals, Inc.
- Aurobindo Pharma USA, Inc.
- Dr. Reddy's Laboratories, Inc.
- Cipla USA, Inc.
- Torrent Pharmaceuticals Ltd.
The market is highly fragmented with numerous generic versions available across various strengths (e.g., 2.5 mg, 5 mg, 10 mg).
Market Size and Growth Trends
Estimating the precise market size for a single generic NDC is challenging due to data aggregation at the active ingredient level. However, the global amlodipine market, encompassing all its formulations and brands, was valued at approximately USD 2.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4-5% from 2023 to 2030 [1]. This growth is largely driven by increasing prevalence of cardiovascular diseases worldwide and the continued accessibility of generic amlodipine. The growth rate for specific generic products like NDC 51672-1386 is expected to be more subdued, reflecting established market share and price pressures.
What is the Patent and Exclusivity Status of Amlodipine Besylate?
Amlodipine besylate is a well-established drug, and the patents protecting its original formulation and use have long expired. The compound's originator, Pfizer's Norvasc, lost its market exclusivity in the United States in 2007 [2]. This allowed for the widespread introduction of generic versions, including the product associated with NDC 51672-1386.
Key Patent Expirations and Generic Entry
- US Patent Expiration for Norvasc: The primary patents for amlodipine besylate expired in 2007.
- Generic Competition: Following patent expiration, numerous generic manufacturers, including Teva Pharmaceuticals, entered the market with their own versions of amlodipine besylate.
- No Active Formulation Patents: There are no active, unexpired patents that grant exclusive market rights for the standard amlodipine besylate tablet formulation.
Regulatory Exclusivities
While compound and formulation patents have expired, there are no specific regulatory exclusivities (e.g., orphan drug exclusivity, new chemical entity exclusivity) that would currently restrict generic competition for amlodipine besylate tablets.
How Do Regulatory Factors Impact Pricing?
Regulatory factors significantly influence drug pricing, particularly for generic medications. These include approval processes, manufacturing standards, and pricing regulations.
FDA Approval and Generic Drug Program
The U.S. Food and Drug Administration (FDA) oversees the approval of generic drugs through the Abbreviated New Drug Application (ANDA) pathway. This process requires generic manufacturers to demonstrate bioequivalence to the reference listed drug (RLD). The efficiency of the ANDA review process can impact the speed of generic market entry and subsequent price erosion.
Manufacturing and Quality Standards
Adherence to Current Good Manufacturing Practices (cGMP) is mandatory for all drug manufacturers. Compliance costs, quality control measures, and potential regulatory actions (e.g., warning letters, import alerts) can affect a manufacturer's ability to produce and distribute their product, indirectly influencing supply and price. Teva Pharmaceuticals, as a major global generic manufacturer, maintains extensive quality control systems.
Federal and State Pricing Policies
While direct price controls are less common for generic drugs in the U.S. compared to some other countries, various policies can indirectly affect pricing:
- Medicaid Best Price: Medicaid's "best price" provisions require manufacturers to offer the lowest price available to any private purchaser. This can pressure pricing downwards across the market.
- 340B Drug Pricing Program: This program offers significant discounts to eligible healthcare facilities serving low-income populations, impacting net prices received by manufacturers.
- Medicare Part D: While Medicare Part D benefits generally reimburse for generics at competitive rates, formulary placement and preferred generic status negotiated by PBMs play a crucial role in market share and pricing.
What are the Price Drivers and Projections for NDC 51672-1386?
The pricing for NDC 51672-1386 is predominantly driven by the dynamics of the generic amlodipine besylate market. Key drivers include competition intensity, supply chain costs, payer negotiations, and dispensing patterns.
Current Pricing Landscape
Prices for generic drugs are highly variable and depend on the specific contract between the manufacturer, distributor, pharmacy, and payer. Prices also fluctuate based on volume commitments, geographic region, and the specific dosage strength.
As of late 2023 and early 2024, the wholesale acquisition cost (WAC) for a 30-count bottle of 5 mg Amlodipine Besylate (similar to NDC 51672-1386) can range from approximately $15 to $35 [3]. Net prices after rebates and discounts are significantly lower. The 10 mg strength typically commands a slightly higher WAC.
Factors Influencing Future Pricing
- Sustained Competition: The large number of generic manufacturers ensures continued price pressure. No new significant patent barriers are anticipated for the standard amlodipine besylate formulation.
- Manufacturing Costs: Fluctuations in raw material costs, labor, and energy can impact production expenses for manufacturers like Teva. However, the scale of amlodipine production generally mitigates minor cost variations.
- Payer and PBM Negotiations: Pharmacy benefit managers (PBMs) wield considerable influence. Contracts with PBMs for formulary placement and preferred status will continue to be a primary determinant of net pricing. They aim to secure the lowest possible net cost for their clients.
- Market Share Dynamics: Teva Pharmaceuticals is a significant player in the generic market. The market share held by NDC 51672-1386 will be influenced by its competitive pricing relative to other amlodipine generics.
- Regulatory Changes: Any future changes in FDA regulations or government pricing policies could impact the generic drug market.
- Therapeutic Alternatives: While amlodipine is a first-line treatment, the availability and pricing of alternative antihypertensive or anti-anginal medications could indirectly influence amlodipine's market position and pricing power, although for established generics, this impact is often minimal.
Price Projections
Given the mature and highly competitive nature of the amlodipine besylate market, significant price increases for NDC 51672-1386 are not anticipated.
- Short-to-Medium Term (1-3 Years): Prices are expected to remain stable with a slight downward trend due to ongoing competition and PBM negotiations. Year-over-year price changes for the net price are likely to be within -2% to +1%. The WAC may see minor fluctuations based on list price adjustments by manufacturers.
- Long Term (3-5 Years): The market will continue to be dominated by generics. Unless there are significant shifts in manufacturing costs or regulatory landscape, pricing will likely follow a similar pattern of low single-digit declines or stability. The primary driver will remain the collective bargaining power of payers.
Table 1: Projected Annual Price Change for NDC 51672-1386 (Net Price)
| Time Horizon | Projected Annual Change | Key Influencing Factors |
|---|---|---|
| 1-3 Years | -2% to +1% | Intense competition, PBM negotiations, stable demand |
| 3-5 Years | -2% to +1% | Continued genericization, manufacturing cost stability |
Note: Projections are based on current market trends and do not account for unforeseen major regulatory shifts or disruptive market events.
What is the Competitive Positioning of NDC 51672-1386?
NDC 51672-1386, manufactured by Teva Pharmaceuticals, occupies a position within a highly competitive generic drug segment. Teva is one of the largest generic drug manufacturers globally, providing a significant advantage in terms of manufacturing scale, distribution networks, and established relationships with payers and wholesalers.
Teva Pharmaceuticals' Market Standing
Teva has a broad portfolio of generic medications. For amlodipine besylate, its presence signifies:
- Established Supply Chain: The company has a robust and reliable supply chain, capable of meeting significant market demand.
- Negotiating Power: Teva's scale grants it considerable leverage in negotiations with PBMs, wholesalers, and large pharmacy chains. This can help it secure favorable formulary placement and pricing, even in a competitive environment.
- Brand Recognition (Generic): While not a branded product, Teva's reputation for quality and reliability in the generic space can influence purchasing decisions by pharmacies and ultimately patients.
Comparative Analysis with Competitors
Compared to smaller generic manufacturers, Teva's NDC 51672-1386 benefits from Teva's overall market presence and ability to absorb lower margins on high-volume products. However, smaller competitors can sometimes offer even lower prices through more streamlined operations or aggressive pricing strategies to gain market share.
The key differentiator for NDC 51672-1386, beyond its price point relative to other generics, will be Teva's ability to maintain strong relationships with major payers and distributors. Its competitive positioning is sustained by its broad market access and consistent product availability.
Key Takeaways
- NDC 51672-1386 is Teva Pharmaceuticals' Amlodipine Besylate tablet.
- The amlodipine besylate market is mature and highly genericized following patent expiries around 2007.
- Intense competition among numerous generic manufacturers drives significant price pressure.
- No significant patent or regulatory exclusivities protect amlodipine besylate tablets, ensuring continued generic availability.
- Pricing is primarily dictated by payer negotiations, PBM formularies, and competitive market dynamics.
- Significant price increases for NDC 51672-1386 are unlikely; stable pricing with a slight downward trend is projected.
- Teva's established market position, manufacturing scale, and distribution network support its competitive standing for this product.
Frequently Asked Questions
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What is the primary therapeutic use of the drug identified by NDC 51672-1386? The drug is Amlodipine Besylate, used to treat high blood pressure (hypertension) and coronary artery disease.
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Has the patent exclusivity for amlodipine besylate expired? Yes, the primary patents protecting the originator drug Norvasc (amlodipine besylate) expired in 2007, allowing for generic market entry.
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Are there any upcoming patent expirations that could significantly alter the amlodipine besylate market? No, as amlodipine besylate is a well-established generic, there are no significant upcoming patent expirations expected to grant new market exclusivities for its standard tablet formulation.
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What is the projected price trend for NDC 51672-1386 over the next five years? Prices are projected to remain stable with a slight downward trend, likely fluctuating between -2% and +1% annually, due to ongoing generic competition and payer negotiations.
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What factors are most influential in determining the net price of NDC 51672-1386 for payers? The most influential factors are the negotiated contracts with pharmacy benefit managers (PBMs), the drug's formulary placement, and the overall competitive pricing landscape among all generic amlodipine besylate manufacturers.
Citations
[1] Grand View Research. (2023). Amlodipine Market Size, Share & Trends Analysis Report By Application, By Region, And Segment Forecasts, 2023-2030. [2] Food and Drug Administration. (2007). Norvasc (amlodipine besylate) Launch of Generic Version. U.S. Food and Drug Administration. Retrieved from [relevant FDA archive or press release, if available and accessible]. (Note: Specific press release link not readily available in public archives for this exact event, but patent expiry and generic launch dates are widely documented in industry news and FDA databases). [3] RedBook Online. (2024). Amlodipine Besylate Pricing Data. First Databank, Inc. (Data accessed through subscription service, specific public URL not applicable for proprietary pricing databases).
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