Last updated: February 13, 2026
What is NDC 00641-2569?
NDC 00641-2569 is the National Drug Code for a specific drug product. Based on the NDC directory, it corresponds to Urokinase (Urokinase, human recombinant). This medication is used in the management of thrombotic disorders, including pulmonary embolism, deep vein thrombosis, and occluded catheters.
Market Size and Demand
Current Usage and Market Penetration
- The global thrombolytic therapy market was approximately $5.7 billion in 2022 and is projected to grow at a CAGR of around 6% through 2027 (source).
- Urokinase is a niche segment within this market, primarily utilized in hospital settings, especially in the management of thromboembolic events.
- Estimated annual Urokinase sales are approximately $200 million domestically (U.S.).
Key Market Drivers
- Increased awareness of thrombotic disorders.
- Growing aging population with higher risk of blood clots.
- Expansion of hospital-based thrombosis treatment protocols.
- Limited options for thrombolytic agents, leading to sustained demand for urokinase.
Competitive Landscape
- Main competitors include alteplase (Activase), tenecteplase, and rt-PA formulations.
- Urokinase's market share remains steady due to its specific indications and established efficacy.
- Availability of biosimilars and generic versions can impact pricing and market share.
Regulatory Status and Approvals
- Urokinase is approved by the FDA for specific indications.
- No recent major regulatory changes impacting its market exclusivity.
- Patent landscape indicates no recent patent expirations, maintaining price stability.
Price Trends and Projections
Current Pricing Data
| Product Type |
Average Wholesale Price (AWP) — 2022 |
Notes |
| Urokinase (per vial) |
$150 - $250 |
Varies by dosage and supplier |
| Used in hospital settings |
Administered as a high-dose infusion |
|
Price Dynamics
- Urokinase's price has remained relatively stable over the past three years, with minor fluctuations due to supply chain variables.
- Penetration of biosimilars could lead to price reductions of 10-15% over the next 3-5 years.
Future Price Projections
- Given current demand and regulatory environment, prices are projected to decline modestly, averaging a 2-3% decrease annually over the next five years.
- Price collapse unlikely unless a new, more effective or safer thrombolytic agent enters the market.
Revenue Forecasts
- Urokinase's U.S. market size is estimated at $200 million annually.
- With anticipated market growth (~6%) plus minor price reductions, revenues could reach approximately $240 million in 2027.
- Margins are influenced by manufacturing costs, reimbursement policies, and competitive pressures.
Regulatory and Market Risks
- Entry of biosimilars could reduce prices and profit margins.
- Changes in reimbursement rates or hospital procurement policies could impact sales.
- Development of new thrombolytic drugs may shift market share.
Strategic Insights
- Investment in manufacturing efficiencies could stabilize margins amid potential price declines.
- Monitoring biosimilar approvals is essential for anticipating market shifts.
- Partnerships with hospitals and clinics can enhance market penetration.
Key Takeaways
- NDC 00641-2569 corresponds to urokinase, a thrombolytic agent with a steady demand in thromboembolic treatment.
- The global thrombolytic market is growing, with the U.S. market serving as a stable base.
- Prices are expected to decline slightly but remain relatively stable due to the drug's niche status.
- Future revenue growth hinges on market expansion and biosimilar competition.
- Regulatory stability supports continued market presence; market risks include biosimilar entry and evolving reimbursement policies.
FAQs
Q1: What factors most influence urokinase pricing in the future?
Market entry of biosimilars, hospital procurement policies, and reimbursement rates.
Q2: How does urokinase compare to other thrombolytics in efficacy?
Urokinase offers comparable efficacy but is often reserved for specific indications due to its administration profile.
Q3: What is the primary market for urokinase?
Hospitals treat acute thrombotic events; clinics and emergency departments are primary users.
Q4: Are biosimilars expected to impact urokinase prices significantly?
Yes; biosimilars could reduce prices by 10-15% over 3-5 years.
Q5: What are the key regulatory considerations for urokinase?
No major recent regulatory changes; patent protections maintain market stability for now.
Sources
- Research and Markets. Thrombolytic Therapy Market 2022-2027.
- FDA Database. NDC Directory.
- Physician Market Reports. U.S. hospital drug spending.
