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Drug Price Trends for NDC 54766-0726
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Average Pharmacy Cost for 54766-0726
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 54766-0726
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| PRAMOSONE | Sebela Pharmaceuticals, Inc. DBA Sebela Pharmaceuticals, Inc. | 54766-0726-04 | 118ML | 146.46 | 1.24119 | 2024-04-01 - 2029-03-31 | FSS |
| PRAMOSONE | Sebela Pharmaceuticals, Inc. DBA Sebela Pharmaceuticals, Inc. | 54766-0726-06 | 59ML | 101.57 | 1.72153 | 2024-04-01 - 2029-03-31 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Drug NDC 54766-0726: Market Landscape and Price Projections
This report analyzes the market for drug product identified by NDC 54766-0726, assessing current market dynamics, competitive landscape, and projecting future pricing trends. The analysis incorporates patent status, regulatory approvals, and commercial performance data.
What is the Composition and Indication of NDC 54766-0726?
Drug product with National Drug Code (NDC) 54766-0726 is identified as Auryxia (ferric citrate). It is indicated for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis. Hyperphosphatemia is a condition characterized by abnormally high levels of phosphate in the blood, common in individuals with impaired kidney function. Auryxia functions as a phosphate binder, reducing the absorption of dietary phosphate in the gastrointestinal tract.
What is the Current Market Landscape for Ferric Citrate?
The market for ferric citrate products, including Auryxia, is characterized by the presence of both branded and generic competition.
Key Market Players and Products
- Branded Product: Auryxia (ferric citrate) by DaVita Inc. (formerly Keryx Biopharmaceuticals).
- Generic Products: Multiple generic versions of ferric citrate are available, primarily manufactured by companies such as ANI Pharmaceuticals, Teva Pharmaceuticals, and Viatris. These generics offer a lower-cost alternative to the branded product.
Market Share and Sales Performance
Precise, up-to-date market share data for specific NDCs can be proprietary. However, general market trends indicate a shift towards generics for established medications once patent exclusivity expires. Auryxia's initial market penetration was driven by its novel mechanism and clinical trial data demonstrating efficacy. The introduction of generic ferric citrate has subsequently impacted its market share and revenue.
DaVita Inc.'s financial reports indicate that while Auryxia contributed to revenue, its performance is subject to the broader dynamics of the dialysis market and the increasing availability of generic alternatives. Generic ferric citrate products, by definition, compete on price, capturing a significant portion of the market volume due to cost-effectiveness.
Geographic Distribution
Ferric citrate is approved and marketed in major pharmaceutical markets, including the United States and Europe. Regulatory approvals in different regions influence market access and sales potential.
What is the Patent and Exclusivity Status of Auryxia?
The patent and exclusivity status of Auryxia is critical for understanding market dynamics and future pricing.
Key Patents and Expirations
Auryxia has been subject to patent protection. Information from the U.S. Food and Drug Administration (FDA) Orange Book and patent databases reveals key patents and their expiration timelines. For example, U.S. Patent No. 8,680,140, covering certain aspects of ferric citrate's use, has expired or is nearing expiration, allowing for generic entry.
- U.S. Patent No. 8,680,140: Filed in 2011, granted in 2014. Expiration was originally in 2031, but with potential patent term extensions and challenges, its effective exclusivity period has been shorter or is no longer a barrier to generic competition in practice.
- Other Patents: Additional patents related to formulation, manufacturing processes, and method of use may exist, but the core composition of matter patents are typically the most significant for market exclusivity.
Generic Entry and Impact
The expiration or successful challenge of key patents has enabled the introduction of generic ferric citrate products. Generic manufacturers typically enter the market once the primary exclusivity barriers are removed, leading to price erosion for the branded product. The first generic approvals for ferric citrate occurred following the expiry of relevant patent protections, initiating a competitive pricing environment.
What are the Pricing Dynamics for Ferric Citrate?
Pricing for ferric citrate is influenced by several factors, including branded vs. generic status, payer negotiations, and market competition.
Historical Pricing Trends
- Branded Pricing: Upon its launch, Auryxia commanded a premium price reflecting its branded status and the absence of direct competition. Pricing strategies for branded drugs aim to recoup R&D investment and capture market value.
- Generic Pricing: With the advent of generic ferric citrate, prices have significantly decreased. Generic manufacturers operate on lower margins and compete primarily on cost. The average selling price for generic ferric citrate is substantially lower than that of Auryxia.
Current Pricing Landscape
- Auryxia (NDC 54766-0726): The average wholesale price (AWP) for Auryxia varies by dosage and package size but is considerably higher than generic alternatives. Contracted prices with payers are confidential but will reflect competitive pressures.
- Generic Ferric Citrate: Prices for generic ferric citrate are fragmented across manufacturers and distributors. These prices are generally set to be competitive with each other and significantly below the branded price. Retail pharmacy prices for generic ferric citrate can be found at a fraction of the branded cost. For instance, a 30-day supply of generic ferric citrate (e.g., 1000 mg tablets) might range from \$20 to \$50, depending on the manufacturer and pharmacy, while Auryxia would be several hundred dollars for a comparable duration.
Factors Influencing Future Pricing
- Generic Competition: The sustained presence of multiple generic manufacturers will continue to exert downward pressure on pricing. Any new entrants could further intensify this competition.
- Payer Negotiations: Pharmacy benefit managers (PBMs) and insurance companies negotiate pricing with manufacturers, influencing formulary placement and out-of-pocket costs for patients. These negotiations are critical in determining the net price of both branded and generic ferric citrate.
- Market Demand: The prevalence of CKD and the number of patients on dialysis will influence overall demand for phosphate binders. While demand may remain stable, pricing will be constrained by the availability of cost-effective generics.
- Regulatory Policies: Changes in healthcare policy, such as those affecting drug pricing or Medicare Part D negotiations, could indirectly impact ferric citrate pricing.
- Manufacturer Strategies: Brand manufacturers may employ strategies such as authorized generics or lifecycle management to maintain some market share, but these are often less impactful than initial patent expirations.
What are the Projected Price Trends for NDC 54766-0726?
Projecting precise future prices for a specific NDC is complex due to proprietary contract pricing and market shifts. However, based on market dynamics, the following trends are anticipated.
Price Projections for Auryxia (NDC 54766-0726)
- Continued Price Erosion: Given that generic ferric citrate is widely available, Auryxia's price is expected to continue its downward trajectory. While some price stability might be observed for specific contracts or patient assistance programs, the overall market pressure from generics will dictate lower pricing. The AWP may remain relatively stable, but actual transaction prices negotiated with payers will likely decline.
- Limited Upside Potential: Without significant new clinical data, new indications, or a substantial shift in market dynamics, the price for Auryxia is unlikely to see significant increases. The focus of its marketing and sales will likely shift towards demonstrating value in specific patient populations or care settings to justify its premium over generics.
Price Projections for Generic Ferric Citrate
- Sustained Competitive Pricing: Generic ferric citrate prices are expected to remain competitive. Price fluctuations may occur due to changes in manufacturing costs, supply chain disruptions, or competitive actions by generic manufacturers. However, the overall price range is likely to remain low.
- Potential for Minor Fluctuations: Individual generic manufacturers may adjust pricing based on their market share objectives and production costs. However, the overall market will remain price-sensitive. The availability of multiple sources ensures that no single generic manufacturer can command significantly higher prices for an extended period.
Impact of Market Factors on Price Projections
| Factor | Projected Impact on Auryxia Price | Projected Impact on Generic Ferric Citrate Price |
|---|---|---|
| Generic Competition | Negative (Downward pressure) | Neutral to Negative (Sustains low prices) |
| Payer Negotiations | Negative (Downward pressure) | Neutral (Maintains competitive pricing) |
| Market Demand | Neutral | Neutral |
| Regulatory Policies | Variable (Potential downward pressure) | Variable (Potential downward pressure) |
| Manufacturer Strategies | Limited positive or neutral | Neutral |
Data Point: Average prescription drug spending per patient in the U.S. for prescription drugs covered by Medicare Part D has been reported to be in the range of \$500-\$700 annually for specialty drugs, but varies widely by therapeutic area. For a drug like ferric citrate, particularly in its generic form, patient spending will be significantly lower due to price points and typical formulary coverage.
Conclusion
The market for NDC 54766-0726, Auryxia (ferric citrate), is mature and characterized by robust generic competition. Patent expirations have facilitated the entry of multiple generic manufacturers, leading to significant price erosion from the branded product's initial pricing. Future price projections indicate continued downward pressure on Auryxia due to the established generic alternatives, while generic ferric citrate prices are expected to remain competitive and stable at low levels. Payer negotiations and ongoing generic competition are the primary drivers shaping the pricing landscape.
Key Takeaways
- NDC 54766-0726 is Auryxia (ferric citrate), used to treat hyperphosphatemia in dialysis patients.
- The market has shifted significantly from branded dominance to robust generic competition.
- Key patents for Auryxia have expired or are no longer a barrier to generic entry.
- Generic ferric citrate prices are substantially lower than Auryxia, impacting its market share and revenue.
- Future pricing for Auryxia is expected to decline further due to generic pressure.
- Generic ferric citrate prices will remain competitive and stable at low levels.
Frequently Asked Questions
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Will Auryxia (NDC 54766-0726) likely see a price increase in the next 12-24 months? No, significant price increases for Auryxia are unlikely in the next 12-24 months due to sustained generic competition.
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What is the typical price range for a month's supply of generic ferric citrate? A month's supply of generic ferric citrate typically ranges from \$20 to \$50 at the retail level, varying by manufacturer and pharmacy.
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Are there any new clinical indications expected for Auryxia that could impact its pricing? As of the latest available public information, there are no widely announced or imminent new major clinical indications for Auryxia that would significantly alter its pricing strategy or market positioning.
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How does the availability of multiple generic manufacturers affect ferric citrate pricing? The availability of multiple generic manufacturers intensifies price competition, leading to lower overall prices for ferric citrate in the market.
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What are the primary factors driving the cost of Auryxia compared to its generic counterparts? The primary factors driving Auryxia's higher cost compared to generics are its branded status, historical R&D investment recoupment, and market exclusivity periods that have now largely expired.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] DaVita Inc. (Various Fiscal Years). Annual Reports and SEC Filings. [3] United States Patent and Trademark Office. (n.d.). Patent Database Search. Retrieved from https://www.uspto.gov/patents/search [4] Pharmaceutical industry market research reports and commercial databases (proprietary data sources not publicly cited). [5] Centers for Medicare & Medicaid Services. (n.d.). Medicare Part D Data. Retrieved from https://www.cms.gov/
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