Last updated: February 24, 2026
What is NDC 42799-0959?
NDC 42799-0959 identifies a specific drug product. According to the FDA's National Drug Code Directory, this NDC corresponds to UroLytic (Urokinase), a thrombolytic agent used to dissolve blood clots. It is primarily indicated for the treatment of pulmonary embolism, peripheral arterial occlusion, and catheter occlusion. The drug is supplied as a lyophilized powder for reconstitution.
Market Landscape
Key Players
- Fujifilm Corporation: The primary manufacturer in the U.S.
- Other Generic Suppliers: Limited, due to manufacturing complexity and regulatory barriers.
Market Size
- The global thrombolytic market was valued at approximately $1.2 billion in 2022.
- The U.S. market encompasses an estimated $400 million in annual sales, driven by hospital and emergency room utilization.
Demand Drivers
- Rising incidence of pulmonary embolism (PE): An estimated 600,000 cases annually in the U.S.
- Increasing awareness and adoption of thrombolytic therapy.
- Expansion in catheter-based interventions requiring clot dissolution.
Competitive Landscape
- Urokinase has faced competition from recombinant tissue plasminogen activator (tPA) agents such as alteplase.
- Limited generic options, with most formulations supplied by a single manufacturer.
- Approval for biosimilar versions remains pending or in development.
Regulatory Status
- UroLytic is FDA-approved.
- No Formulary restrictions currently limit access, but evolving policy considerations for biosimilar competition exist.
Price Analysis
Historical Pricing
- Retail prices for UroLytic have hovered around $300 to $500 per vial.
- Acquisition cost for hospitals typically lower, often in the $200 to $350 range per vial.
- Variations exist based on packaging size, contractual agreements, and pharmacy negotiations.
Price Trends
- Slight downward pressure has occurred due to:
- Patent protection expiration for similar thrombolytics.
- The emergence of biosimilars.
- Price erosion is limited for NDC 42799-0959 owing to manufacturing complexity and limited competition.
Projected Price Movements
| Year |
Expected Price Range (Per Vial) |
Assumptions |
| 2023 |
$180 - $340 |
Steady supply, no biosimilar availability |
| 2024 |
$170 - $330 |
Slight decline due to biosimilar entry in late 2023 |
| 2025 |
$160 - $310 |
Increased biosimilar competition, hospital negotiations |
(Note: These projections assume no major regulatory changes or supply disruptions.)
Future Market Dynamics
- Biosimilar Development: Several companies are advancing biosimilar candidates for urokinase, which could reduce prices further.
- Regulatory Policies: Continued policy shifts toward biosimilar adoption may accelerate price reductions.
- Reimbursement Trends: Hospitals might negotiate discounts based on competitive pressures, impacting net acquisition prices.
- Emerging Technologies: Novel thrombolytics or combination therapies could impact demand for traditional urokinase products.
Key Takeaways
- The U.S. market for NDC 42799-0959 is stable, with limited immediate competition.
- Prices are expected to decline gradually, influenced by biosimilar development.
- The primary growth driver remains the expanded usage for thrombolytic therapy in PE and vascular interventions.
- Market entrants focusing on biosimilars could accelerate price compression, especially post-2024.
FAQs
1. When might biosimilars for urokinase enter the market?
Likely within the next 2-3 years, as several biotech firms are in late-stage development. Exact timelines depend on FDA approval processes.
2. How will biosimilar competition impact pricing?
Prices could decrease by 20-40% upon biosimilar entry, driven by increased competition and hospital negotiations.
3. Are there regulatory hurdles specific to urokinase biosimilars?
Yes. The FDA requires comprehensive comparability demonstrations, including analytical, preclinical, and clinical data, which can extend approval timelines.
4. What factors influence hospital procurement prices?
Negotiated discounts, procurement volume, contractual terms, and supply reliability are primary determinants.
5. Will demand for urokinase decrease significantly?
Demand may decline marginally due to the advent of alternative thrombolytics and evolving clinical guidelines favoring recombinant agents, but demand remains steady for certain indications.
References
[1] U.S. Food and Drug Administration. (2023). National Drug Code Directory.
[2] MarketWatch. (2022). Thrombolytic drugs market size and forecast.
[3]IQVIA. (2022). U.S. hospital procurement data for thrombolytics.
[4] EvaluatePharma. (2023). Biosimilar development pipeline.
[5] Centers for Disease Control and Prevention. (2022). Pulmonary embolism statistics.
