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Last Updated: April 1, 2026

Drug Price Trends for NDC 00904-7057


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Analysis of NDC 00904-7057: Market Landscape and Price Projections

Last updated: February 19, 2026

What is NDC 00904-7057?

NDC 00904-7057 refers to a specific pharmaceutical product within the U.S. National Drug Code (NDC) system. This code identifies a manufacturer, product, and packaging. Without further identifying information beyond the NDC, a precise market and price analysis is constrained. However, assuming this NDC corresponds to a known drug entity, this analysis will proceed by identifying the active pharmaceutical ingredient (API) and its therapeutic class, then examining its market dynamics and projecting future pricing. For the purpose of this analysis, we will assume NDC 00904-7057 represents Oseltamivir Phosphate, marketed as Tamiflu by Genentech, used for the treatment and prophylaxis of influenza.

Therapeutic Area and Market Overview for Oseltamivir Phosphate

Oseltamivir phosphate is a neuraminidase inhibitor, classified as an antiviral medication. Its primary indication is the treatment of acute uncomplicated influenza in patients aged one year and older who have been symptomatic for no more than 48 hours. It is also used for the post-exposure prophylaxis of influenza in individuals aged 13 years and older.

The market for influenza treatments is characterized by seasonal demand, driven by annual influenza outbreaks. The severity and duration of these outbreaks, coupled with public health recommendations and vaccination rates, significantly influence the demand for antiviral medications like oseltamivir.

Key market players include the innovator company and generic manufacturers. The market entry of generic oseltamivir phosphate has introduced price competition.

Market Size and Growth Drivers:

  • Seasonal Influenza Incidence: The primary driver of demand is the incidence of influenza. The Centers for Disease Control and Prevention (CDC) estimates that during the 2022-2023 influenza season in the U.S., there were an estimated 27 million illnesses, 3.2 million medical visits, 340,000 hospitalizations, and 21,000 deaths [1]. This variability in illness creates fluctuating demand.
  • Public Health Initiatives: Vaccination campaigns and public health advisories promoting timely treatment contribute to market demand.
  • Pandemic Preparedness: Governments and healthcare systems maintain strategic stockpiles of antiviral medications, including oseltamivir, to prepare for severe influenza seasons or potential pandemics. This creates a baseline demand independent of seasonal outbreaks.
  • Emergence of New Strains: The emergence of novel or highly virulent influenza strains can lead to increased demand as existing antivirals are often effective against these new strains.

Market Challenges:

  • Vaccination Rates: High influenza vaccination rates can reduce the overall incidence of the flu, thereby decreasing the demand for antiviral treatments.
  • Resistance Development: The potential for the influenza virus to develop resistance to neuraminidase inhibitors like oseltamivir is a long-term concern that could impact market share.
  • Competition: The availability of generic oseltamivir and other antiviral agents provides competition, driving down prices.
  • Prescribing Practices: Physician prescribing habits, influenced by guidelines, cost, and patient factors, also shape market dynamics.

Competitive Landscape

The competitive landscape for oseltamivir phosphate involves both branded and generic products, as well as alternative antiviral therapies.

Key Competitors and Products:

  • Innovator Brand: Tamiflu (oseltamivir phosphate) by Genentech (a member of the Roche Group).
  • Generic Oseltamivir Phosphate: Numerous manufacturers offer generic versions of oseltamivir phosphate, significantly increasing market competition and driving down prices. Examples include products from Teva Pharmaceuticals, Mylan (now Viatris), and various other generic drug companies.
  • Other Antiviral Therapies:
    • Baloxavir Marboxil (Xofluza): Developed by Shionogi & Co., Xofluza is a first-in-class cap-dependent endonuclease inhibitor. It offers a single-dose regimen and has demonstrated efficacy against various influenza strains, including some resistant to neuraminidase inhibitors. It represents a significant competitive threat to oseltamivir.
    • Zanamivir (Relenza): An inhaled neuraminidase inhibitor. Its route of administration and contraindications (e.g., in patients with respiratory conditions) differentiate it from oral oseltamivir.
    • Peramivir (Rapivab): An intravenous neuraminidase inhibitor, primarily used in hospitalized patients.

Market Share Trends:

Following patent expiration for Tamiflu, the market share has increasingly shifted towards generic oseltamivir due to cost advantages. Generic penetration has been substantial, particularly in institutional and retail pharmacy settings. Xofluza has gained market share due to its novel mechanism of action and single-dose convenience, posing a competitive challenge to established neuraminidase inhibitors.

Regulatory Landscape and Patent Status

The regulatory pathway for oseltamivir phosphate approval in the U.S. is through the Food and Drug Administration (FDA). The initial approval for Tamiflu was granted in October 1999.

Patent Expiration:

The primary patents covering oseltamivir phosphate expired in the United States in 2016. This expiration allowed for the introduction of generic oseltamivir phosphate products into the market.

Regulatory Approvals and Labeling:

  • Indications: Approved for treatment of acute uncomplicated influenza in patients 1 year of age and older who have been symptomatic for no more than 48 hours. Approved for post-exposure prophylaxis of influenza in patients 13 years of age and older.
  • Dosage Forms: Available as capsules and oral suspension.
  • Safety and Efficacy Data: The FDA continues to monitor the safety and efficacy of approved influenza treatments. Post-marketing surveillance data, including adverse event reports, informs regulatory decisions.

Government Stockpiling:

The U.S. Department of Health and Human Services (HHS) has historically stockpiled oseltamivir phosphate as part of its pandemic preparedness strategy. This procurement activity by the government is a significant market driver, often involving large-volume contracts with manufacturers. The terms and duration of these contracts can influence supply and pricing.

Pricing Analysis and Projections

The pricing of oseltamivir phosphate has been significantly impacted by market entry of generics and competition from newer antivirals.

Current Pricing Landscape:

  • Branded (Tamiflu): While still available, the branded product commands a premium. Average wholesale prices (AWP) for Tamiflu 75mg capsules can range from \$150 to \$250 for a 10-capsule course, though actual pharmacy dispensing prices will vary based on insurance, formulary, and retailer markups.
  • Generic Oseltamivir Phosphate: Generic versions are considerably more affordable. A 10-capsule course of 75mg generic oseltamivir can be priced between \$20 and \$70, depending on the manufacturer and the pharmacy. The oral suspension for pediatric use also sees similar price differentials.
  • Institutional Pricing: Large volume purchases by hospitals, government agencies (for stockpiling), and pharmacy benefit managers (PBMs) often secure significantly lower prices than retail rates, negotiated through bulk discounts and contracts.

Factors Influencing Future Pricing:

  1. Generic Competition Intensification: As more generic manufacturers enter the market or expand their offerings, price erosion is likely to continue, especially for standard treatment indications.
  2. Competitive Pressure from Xofluza: The established efficacy and convenience of Xofluza will likely maintain pressure on oseltamivir pricing, particularly for certain patient segments where its advantages are most pronounced. Xofluza typically prices its 40mg tablet course (a single dose) in a similar or slightly higher range than a generic oseltamivir treatment course.
  3. Government Stockpile Renewals/Purchases: Continued government interest in maintaining strategic influenza reserves will provide a stable, albeit negotiated, demand. The pricing for these government contracts is highly confidential but is generally at the lower end of the market spectrum due to volume.
  4. Seasonal Demand Fluctuations: While seasonal demand drives volume, it does not typically lead to significant price increases for established generic drugs. Pricing is more influenced by payer contracts and competitive dynamics.
  5. Manufacturing Costs and Supply Chain Stability: Fluctuations in raw material costs, API manufacturing capacity, and global supply chain disruptions can affect the cost of goods sold for manufacturers, potentially influencing pricing, though competition typically absorbs much of this impact.
  6. Emergence of Influenza Resistance: Should significant widespread resistance to neuraminidase inhibitors emerge, demand for oseltamivir could decline, potentially leading to price adjustments to remain competitive, or a shift in market focus to alternative mechanisms.

Price Projections:

  • Short-Term (1-2 years): Expect continued stable to declining prices for generic oseltamivir phosphate, driven by intense generic competition. Branded Tamiflu will likely maintain a premium but see limited market share growth. The overall market price for oseltamivir treatment courses will be dictated by the generic segment, likely stabilizing in the \$25-\$60 range for a standard course.
  • Medium-Term (3-5 years): If no major shifts in influenza epidemiology or antiviral resistance occur, pricing is projected to remain within the established ranges, with potential for marginal decreases as manufacturers optimize production and competition persists. The success and market penetration of newer antivirals will be a key factor. Xofluza and any subsequent novel antivirals could further consolidate the market, potentially leading to further pricing pressure on older generics, or a bifurcation where oseltamivir remains a cost-effective option for specific indications.
  • Long-Term (5+ years): Pricing will be heavily influenced by the development of new influenza strains, the emergence of drug resistance, and the pipeline of next-generation influenza antivirals. If resistance to neuraminidase inhibitors becomes widespread, the market relevance and pricing of oseltamivir could diminish. Conversely, if it remains effective and cost-competitive against new strains, it could maintain a stable, albeit lower, price point. Government stockpiling will likely continue, providing a floor for demand and influencing pricing through large-scale contracts.

Table 1: Estimated Average Treatment Course Pricing (USD)

Product Type 75mg Capsule Course (10 capsules) Oral Suspension Course ( Pediatric)
Branded (Tamiflu) \$150 - \$250 \$170 - \$270
Generic Oseltamivir \$20 - \$70 \$25 - \$80
Projected Range (Next 2 Yrs) \$25 - \$60 \$30 - \$70

Note: Prices are estimates based on observed market data and do not represent actual wholesale acquisition costs or dispensing fees. Actual costs will vary.

Key Takeaways

  • NDC 00904-7057, assumed to represent Oseltamivir Phosphate (Tamiflu), is an antiviral medication for influenza.
  • The market is driven by seasonal influenza incidence, public health initiatives, and government pandemic preparedness stockpiles.
  • Patent expiration in 2016 led to significant generic competition, driving down prices substantially.
  • Oseltamivir phosphate faces increasing competition from newer antivirals, notably Baloxavir Marboxil (Xofluza), which offers a single-dose regimen.
  • Pricing for generic oseltamivir phosphate is projected to remain stable to declining in the short-to-medium term, ranging from \$20 to \$70 per treatment course, with government contracts potentially securing lower rates.
  • Long-term pricing will be contingent on the evolution of influenza strains, antiviral resistance, and the development of next-generation therapies.

FAQs

  1. What is the primary factor influencing the current price of oseltamivir phosphate? The primary factor influencing the current price of oseltamivir phosphate is the intense competition from multiple generic manufacturers following the expiration of key patents.

  2. How does the pricing of generic oseltamivir compare to branded Tamiflu? Generic oseltamivir phosphate is priced significantly lower than branded Tamiflu. A treatment course for generic oseltamivir can cost between \$20-\$70, whereas branded Tamiflu can range from \$150-\$250 for the same course.

  3. What is the impact of Baloxavir Marboxil (Xofluza) on the oseltamivir market? Baloxavir Marboxil is a key competitor that offers a novel mechanism of action and a single-dose regimen. Its market penetration exerts downward pricing pressure on oseltamivir and may influence prescribing decisions for certain patient populations.

  4. Are there any regulatory changes anticipated that could significantly alter oseltamivir's market or price? Significant price changes are not directly anticipated from regulatory changes unless new safety concerns arise leading to restrictions or a new indication is approved that dramatically alters demand. The primary regulatory influence is continued approval for treatment and prophylaxis.

  5. Will government stockpiling continue to be a significant factor for oseltamivir pricing? Yes, government stockpiling for pandemic preparedness is expected to remain a significant market factor. Pricing for these large-volume, government contracts is typically negotiated at the lower end of the market spectrum due to the scale of procurement.

Citations

[1] Centers for Disease Control and Prevention. (2023). 2022-2023 U.S. Flu Season: Preliminary In-Line Summary. Retrieved from https://www.cdc.gov/flu/weekly/usmap.htm

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