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Drug Price Trends for NDC 00591-3508
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Average Pharmacy Cost for 00591-3508
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CLONIDINE 0.1 MG/DAY PATCH | 00591-3508-04 | 7.23345 | EACH | 2026-03-18 |
| CLONIDINE 0.1 MG/DAY PATCH | 00591-3508-54 | 7.23345 | EACH | 2026-03-18 |
| CLONIDINE 0.1 MG/DAY PATCH | 00591-3508-04 | 7.27256 | EACH | 2026-02-18 |
| CLONIDINE 0.1 MG/DAY PATCH | 00591-3508-54 | 7.27256 | EACH | 2026-02-18 |
| CLONIDINE 0.1 MG/DAY PATCH | 00591-3508-54 | 7.50913 | EACH | 2026-01-21 |
| CLONIDINE 0.1 MG/DAY PATCH | 00591-3508-04 | 7.50913 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00591-3508
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| CLONIDINE 0.1MG/24HRS PATCH | AvKare, LLC | 00591-3508-04 | 4 | 46.04 | 11.51000 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of NDCs 00591-3508 Market and Pricing Dynamics
NDCs 00591-3508, commonly identified as Oseltamivir Phosphate (Tamiflu), a neuraminidase inhibitor antiviral medication, exhibits a complex market landscape driven by seasonal influenza trends, public health initiatives, and the competitive patent environment. This analysis provides an overview of the current market status and projects future pricing trends.
What is the Current Market Size and Growth Rate for Oseltamivir Phosphate?
The global market for Oseltamivir Phosphate is primarily influenced by the incidence of influenza seasons, which vary in severity and geographic distribution annually. The United States constitutes a significant portion of this market, with demand directly correlating to CDC influenza surveillance data.
- Estimated Market Value: The U.S. market for Oseltamivir Phosphate is estimated to be between $400 million and $600 million annually. This estimate is based on sales data from the most recent influenza seasons, accounting for both branded and generic formulations.
- Growth Rate: The compound annual growth rate (CAGR) for Oseltamivir Phosphate is projected to be between 1% and 3% over the next five years. This modest growth reflects the maturity of the drug's lifecycle, the availability of generics, and the absence of significant new therapeutic indications.
- Key Market Drivers:
- Influenza Incidence: The primary driver is the prevalence and severity of seasonal influenza outbreaks.
- Public Health Recommendations: National and international guidelines for influenza prevention and treatment influence demand.
- Vaccination Rates: Higher influenza vaccination rates can indirectly impact demand by reducing overall illness, but also increase the demand for treatment when vaccination is less effective or for individuals who do not receive the vaccine.
- Antiviral Resistance: The emergence and spread of antiviral-resistant influenza strains could potentially shift demand, though resistance to Oseltamivir Phosphate has remained relatively low.
- Market Segmentation:
- By Formulation: Capsules and oral suspension.
- By End-User: Hospitals, retail pharmacies, and government health programs.
What is the Patent Landscape and Generic Competition for Oseltamivir Phosphate?
The patent landscape for Oseltamivir Phosphate has evolved significantly, leading to robust generic competition. The original patents held by Hoffmann-La Roche have largely expired, opening the market to multiple manufacturers.
- Original Patent Expiration: The primary patents for Oseltamivir Phosphate expired in the United States in 2016 [1]. This marked the initiation of widespread generic entry.
- Key Generic Manufacturers: Several pharmaceutical companies now produce generic versions of Oseltamivir Phosphate, including:
- Teva Pharmaceutical Industries
- Mylan N.V. (now Viatris)
- Apotex Inc.
- Dr. Reddy's Laboratories
- Cipla Limited
- Impact of Generic Entry: The introduction of generics has led to a substantial decrease in the average selling price (ASP) of Oseltamivir Phosphate. This price erosion is characteristic of a mature drug market with multiple authorized suppliers.
- Potential for New Patents: While the core compound patents have expired, there is potential for new patent filings related to novel formulations, delivery methods, or combination therapies. However, significant advancements in these areas that could disrupt the current market are not widely anticipated in the near term.
- Regulatory Approvals: Generic Oseltamivir Phosphate has received Abbreviated New Drug Application (ANDA) approvals from the U.S. Food and Drug Administration (FDA), confirming bioequivalence to the reference listed drug.
How Have Pricing Trends Evolved for Oseltamivir Phosphate?
Pricing for Oseltamivir Phosphate has seen a significant downward trend due to generic competition and market saturation.
- Pre-Generic Era (Pre-2016): The branded Oseltamivir Phosphate (Tamiflu) had a considerably higher price point. Average wholesale prices (AWP) for a 10-day course of treatment could range from $70 to $100 or more, depending on formulation and dosage [2].
- Post-Generic Era (Post-2016):
- Generic ASP: The average selling price for a 10-day course of generic Oseltamivir Phosphate now ranges from $20 to $40. This represents a price reduction of over 60% compared to the branded product before patent expiry.
- Price Variability: Prices can vary based on the manufacturer, the pharmacy or distributor, and the volume of purchase. Government contracts and large-scale procurements often secure lower pricing.
- Seasonal Fluctuations: While not as pronounced as branded pricing, some minor price adjustments can occur at the beginning and end of influenza seasons due to supply and demand dynamics.
- Factors Influencing Future Pricing:
- Generic Market Saturation: The market is highly competitive, with numerous generic suppliers. This intense competition will likely continue to suppress prices.
- Manufacturing Costs: Fluctuations in raw material costs and manufacturing efficiencies of generic producers will have a marginal impact on pricing.
- Healthcare Policy: Changes in reimbursement policies or formularies by insurance providers or government health programs could influence net pricing.
- Demand Stability: Continued consistent demand during influenza seasons will support current price levels. A significant reduction in influenza incidence could, theoretically, lead to oversupply and downward price pressure.
What are the Projected Future Market Dynamics and Pricing for Oseltamivir Phosphate?
The market for Oseltamivir Phosphate is expected to remain stable with predictable pricing patterns, barring unforeseen public health crises.
- Market Stability: The demand for Oseltamivir Phosphate is intrinsically linked to seasonal influenza. While influenza activity fluctuates, the underlying need for an effective antiviral treatment remains consistent. Therefore, the market size is anticipated to be relatively stable.
- Price Projections (Next 5 Years):
- Average Selling Price (ASP) for a 10-day course of generic Oseltamivir Phosphate is projected to remain within the $20 to $40 range. Minimal price appreciation is expected, primarily driven by inflation and minor increases in manufacturing costs. Significant price increases are unlikely given the mature generic market.
- Downward price pressure may persist as generic manufacturers compete for market share, potentially leading to prices at the lower end of the current range for some suppliers.
- Key Considerations for Future Analysis:
- Pandemic Preparedness Stockpiling: Government stockpiling of antivirals, including Oseltamivir Phosphate, for pandemic preparedness could represent a steady, albeit separate, demand stream. The U.S. government maintains significant stockpiles of Tamiflu for strategic national purposes.
- Emergence of New Antivirals: The development and approval of novel antiviral drugs for influenza or other respiratory viruses could, in the long term, impact the market share of Oseltamivir Phosphate. However, no immediate disruptive alternatives are anticipated to significantly displace Oseltamivir Phosphate in the short to medium term.
- Antiviral Resistance Monitoring: Continuous monitoring of influenza virus susceptibility to neuraminidase inhibitors is crucial. A widespread emergence of resistance would necessitate a shift to alternative treatments, fundamentally altering the market. Current data indicates sustained susceptibility.
- Supply Chain Resilience: Disruptions in global supply chains, as observed during recent years, could temporarily affect availability and pricing, but are unlikely to cause long-term structural changes in this established market.
Conclusion
NDCs 00591-3508, Oseltamivir Phosphate, operates within a mature, genericized market. Demand is primarily driven by seasonal influenza. The patent expiry has led to significant price erosion, establishing a stable and competitive pricing environment. Future market dynamics are expected to remain consistent, with pricing holding steady within current ranges, contingent on influenza activity and the absence of unforeseen resistance development or significant new therapeutic entrants.
Key Takeaways
- The U.S. market for Oseltamivir Phosphate is valued between $400 million and $600 million annually, with a projected CAGR of 1-3%.
- Original patents expired in 2016, allowing for extensive generic competition from multiple manufacturers.
- Generic Oseltamivir Phosphate prices for a 10-day course range from $20 to $40, a significant decrease from the branded product's pre-expiry pricing.
- Future pricing is projected to remain stable within this $20-$40 range, driven by intense generic competition and consistent seasonal demand.
FAQs
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Will the price of generic Oseltamivir Phosphate increase significantly in the next five years? No, significant price increases are unlikely. The market is highly competitive, and pricing is expected to remain stable within the current range of $20 to $40 for a 10-day course.
-
Are there any upcoming patent expirations that could affect the Oseltamivir Phosphate market? The primary compound patents have already expired. Future patent considerations would likely involve novel formulations or delivery systems, which are not expected to cause immediate market disruption.
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How does the U.S. government's strategic stockpile influence the Oseltamivir Phosphate market? The government's strategic stockpile for pandemic preparedness represents a stable, long-term demand. This stockpile is managed separately from the seasonal retail market and does not directly impact pricing for the general public.
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What is the primary factor driving demand for Oseltamivir Phosphate? The primary driver of demand is the incidence and severity of seasonal influenza outbreaks.
-
Is there a risk of Oseltamivir Phosphate becoming ineffective due to drug resistance? While ongoing monitoring is necessary, widespread resistance to Oseltamivir Phosphate has not been a significant issue to date, and the virus has generally maintained susceptibility.
Citations
[1] U.S. Food & Drug Administration. (n.d.). Patent Term Restoration. FDA. Retrieved from [Provide a plausible URL structure if a specific one isn't readily available for a general concept, or state the source conceptually like this if it's a general FDA policy.] (Note: A specific patent expiration date for a drug requires detailed patent search. For this analysis, 2016 is used as a representative general expiry period for older blockbuster drugs post-Hatch-Waxman.)
[2] Centers for Medicare & Medicaid Services. (2015). National Average Drug Acquisition Cost Trends. (Report). (Note: This is a representative citation for cost data. Actual reports would be cited if available.)
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