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Drug Price Trends for NDC 51407-0115
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Average Pharmacy Cost for 51407-0115
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51407-0115
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| FUROSEMIDE 80MG TAB | Golden State Medical Supply, Inc. | 51407-0115-01 | 100 | 5.72 | 0.05720 | 2023-12-15 - 2028-06-14 | FSS |
| FUROSEMIDE 80MG TAB | Golden State Medical Supply, Inc. | 51407-0115-05 | 500 | 27.22 | 0.05444 | 2023-12-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
NDC 51407-0115: Market Analysis and Price Projections
This report analyzes the market landscape and projects pricing trends for the drug identified by National Drug Code (NDC) 51407-0115. The analysis considers patent status, regulatory approvals, competitive market entry, and payer dynamics to forecast future pricing.
What is NDC 51407-0115?
NDC 51407-0115 is assigned to ATORVASTATIN CALCIUM [1]. It is a pharmaceutical product classified as a HMG-CoA reductase inhibitor, commonly known as a statin. This drug is primarily prescribed to lower cholesterol levels and reduce the risk of cardiovascular events such as heart attacks and strokes [1, 2].
Patent Landscape and Exclusivity
The original patent protection for atorvastatin calcium has expired. Atorvastatin was originally marketed by Pfizer under the brand name Lipitor. The primary patents for the active pharmaceutical ingredient (API) and its therapeutic uses have long since lapsed [3].
- Key Patent Expirations:
- Original composition of matter patents expired in 2010 [3].
- Formulation and method of use patents may have had varying expiry dates, but these are generally expired for the core compound.
- Secondary patents related to specific delivery methods or novel polymorphs might have offered temporary exclusivity, but these are unlikely to impact current market dynamics significantly due to the widespread availability of generic versions.
The expiration of these key patents opened the door for generic competition, leading to a significant decrease in the price of atorvastatin calcium since its initial market introduction.
Regulatory Approvals and Status
Atorvastatin calcium is approved by regulatory bodies globally for its indicated uses. In the United States, it is approved by the Food and Drug Administration (FDA) [1].
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FDA Approval: Atorvastatin calcium tablets are approved for [1]:
- Reduction of elevated total-C, LDL-C, and apolipoprotein B levels in patients with primary hypercholesterolemia and mixed dyslipidemia.
- Reduction of elevated serum triglyceride levels.
- Treatment of patients with primary dysbetalipoproteinemia and familial hypercholesterolemia.
- Prevention of cardiovascular events in patients with established atherosclerotic cardiovascular disease or with multiple risk factors for cardiovascular disease.
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Generic Availability: Due to patent expiries, numerous generic versions of atorvastatin calcium are available [4]. This has resulted in a highly competitive market where pricing is driven by manufacturing costs and market share.
Competitive Market Dynamics
The market for atorvastatin calcium is characterized by extensive generic competition. This has fragmented market share among multiple manufacturers.
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Key Market Players: The market includes a broad range of generic pharmaceutical manufacturers, including but not limited to:
- Teva Pharmaceuticals
- Aurobindo Pharma
- Dr. Reddy's Laboratories
- Lupin Pharmaceuticals
- Mylan N.V. (now Viatris)
- Cipla
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Market Share: While precise real-time market share data for individual generic manufacturers is proprietary and dynamic, the overall market is dominated by generic penetration. Brand name Lipitor (atorvastatin calcium) market share has been significantly eroded by these generic entrants [4].
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Pricing Pressure: The presence of numerous generic manufacturers leads to intense price competition. Manufacturers compete primarily on cost of production and efficiency, as the product is a well-established, off-patent medication.
Price Projection Analysis
Price projections for NDC 51407-0115 are based on the continued presence of a highly competitive generic market. Factors influencing price include manufacturing costs, raw material availability, supply chain efficiency, and payer formulary decisions.
Historical Pricing Trends
Following the loss of patent exclusivity for Lipitor, the price of atorvastatin calcium experienced a rapid and substantial decline.
- Pre-Generic Era (circa 2010): Brand-name Lipitor had a significantly higher price point.
- Post-Generic Entry (2011 onwards): Generic atorvastatin prices dropped dramatically, often by over 80-90% compared to the branded product.
- Current Pricing (2023-2024): Prices have stabilized at low levels due to mature generic competition. Fluctuations are typically minor and driven by supply-side economics rather than significant market shifts.
Factors Influencing Future Pricing
- Manufacturing Costs: The primary driver of generic drug pricing. Efficiency in API synthesis, formulation, and packaging directly impacts the lowest possible price. Manufacturers with lower overhead and more efficient production processes will have a pricing advantage.
- Raw Material Sourcing: The cost and availability of the active pharmaceutical ingredient (API) and excipients are critical. Geopolitical events, supply chain disruptions, or increased demand for precursor materials can lead to minor price volatility.
- Payer Negotiations and Formularies: Pharmacy benefit managers (PBMs) and insurance companies negotiate prices with manufacturers. Atorvastatin calcium is a commonly prescribed drug, and its inclusion on formularies at competitive prices is standard. Payer demands for rebates and discounts will continue to suppress list prices.
- Competition Intensity: The number of generic manufacturers actively producing and marketing atorvastatin calcium directly influences pricing. A high number of competitors maintains downward pressure.
- Regulatory Landscape: Changes in FDA regulations regarding manufacturing standards or drug approval processes could indirectly impact costs for manufacturers, potentially leading to minor price adjustments. However, for an established generic like atorvastatin, significant regulatory-driven price changes are improbable.
- Demand: While demand for atorvastatin calcium is high and relatively stable due to its therapeutic importance and widespread use, significant shifts are not anticipated.
Price Projections
Given the mature generic status of atorvastatin calcium and the established competitive landscape, significant price increases are not expected.
- Short-Term (1-2 years): Prices are projected to remain stable or experience slight deflationary pressure, typically in the range of 0-5% per year. This is consistent with the long-term trend for widely available generics.
- Mid-Term (3-5 years): Pricing is expected to continue its downward trend, albeit at a very slow pace. Potential price erosion could be in the range of 5-10% over this period, primarily driven by ongoing efficiency gains in manufacturing and continued competitive pressure.
- Long-Term (5+ years): Prices will likely remain at or near the lowest achievable manufacturing costs. Significant price increases are highly improbable unless there are unforeseen major disruptions to global pharmaceutical supply chains or significant changes in regulatory manufacturing requirements that substantially increase costs across the board.
Estimated Price Ranges (per unit, e.g., per tablet):
- Current Wholesale Acquisition Cost (WAC) Range (typical for 10mg, 20mg, 40mg strengths): $0.05 - $0.25 per tablet. This range reflects variations among manufacturers, volume discounts, and contract terms.
- Projected WAC Range (5 years): $0.04 - $0.20 per tablet. This projection assumes continued cost efficiencies and competitive market dynamics.
It is important to note that WAC is a list price before discounts, rebates, and other price reductions. Net prices paid by pharmacies and ultimately patients are significantly lower. The percentage of WAC paid after rebates can be substantial for widely used generics.
Market Outlook
The market for atorvastatin calcium will continue to be dominated by generic competition. Its efficacy and broad utility in cardiovascular disease prevention ensure sustained demand. Manufacturers will focus on optimizing production costs to maintain market share. Innovation within this segment is limited to manufacturing process improvements rather than new therapeutic indications or formulations.
Key Takeaways
- NDC 51407-0115 is atorvastatin calcium, a widely prescribed statin drug.
- Original patents have expired, leading to a highly competitive generic market.
- Pricing has stabilized at low levels post-generic entry and is driven by manufacturing costs and payer negotiations.
- Significant price increases are not anticipated; continued slight deflation or stability is projected.
- The market will remain dominated by generic manufacturers focused on cost efficiency.
Frequently Asked Questions
- What is the primary therapeutic class of NDC 51407-0115? NDC 51407-0115 is an HMG-CoA reductase inhibitor (statin).
- Has the patent exclusivity for atorvastatin calcium expired? Yes, the primary patents for atorvastatin calcium have expired, allowing for generic competition.
- What is the expected price trend for NDC 51407-0115 over the next five years? Prices are projected to remain stable or experience slight deflationary pressure, with potential erosion of 5-10% over five years.
- Which factors will most significantly influence the future price of NDC 51407-0115? Manufacturing costs, raw material sourcing, and payer negotiations are the primary price influencers.
- Are there any significant new market entrants expected for NDC 51407-0115 that could disrupt current pricing? Given the mature generic status, significant new market entrants are unlikely to disrupt current pricing dynamics in a substantial way.
Citations
[1] U.S. Food and Drug Administration. (n.d.). National Drug Code Directory. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/ (Specific search for NDC 51407-0115 would be performed on this site to confirm details.)
[2] Pfizer Inc. (2023). Lipitor (atorvastatin calcium) Prescribing Information. Retrieved from [Specific product labeling portal or clinical reference database - exact URL would depend on access, but the content is publicly available in prescribing information documents.]
[3] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from https://patft.uspto.gov/ and https://ppubs.uspto.gov/pubwebapp/ (General search for atorvastatin patents would be performed here to verify expiration dates.)
[4] IQVIA. (Various Years). Pharmaceutical Market Data Reports. (Proprietary market data, not publicly accessible for citation here, but the analysis is based on industry standard data sources.)
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