Last updated: February 15, 2026
What is NDC 16571-0694?
NDC 16571-0694 designates a specific pharmaceutical product. According to the FDA’s National Drug Code Directory, this identifier corresponds to Urokinase (recombinant), indicated for dissolving blood clots in certain clinical settings.
What is the Current Market Landscape?
- Approved Use: Tissue plasminogen activator for thrombolytic therapy.
- Manufacturers: Currently, no marketed recombinant urokinase in the U.S. marketplace. The product is under development or has limited regional availability.
- Existing Competition: Alternative therapies include alteplase, reteplase, and tenecteplase, all of which have established markets and substantial R&D backing.
- Market Size: The global thrombolytic therapy market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a CAGR of 8% through 2030, driven by rising stroke and MI incidence rates.
What Are the Key Factors Affecting Market Entry?
- Regulatory Barriers: Approval relies on demonstrating comparable efficacy and safety to existing thrombolytics.
- Manufacturing Challenges: Recombinant urokinase is complex to produce, which influences production costs.
- Pricing Policies: U.S. Medicare and private payer reimbursement rates influence market penetration and profitability.
- Patent and Exclusivity: Patent status impacts market longevity and pricing power.
What Are the Price Trends?
Current Pricing Benchmarks:
| Drug Name |
Typical Wholesale Acquisition Price (WAC) |
Notes |
| Alteplase (tPA) |
USD 1,500 - 2,000 per 50 mg vial |
Standard thrombolytic therapy in stroke |
| Reteplase |
USD 1,200 - 1,800 per vial |
Used for acute MI |
| Tenecteplase |
USD 1,600 - 2,200 per vial |
Single-bolus, used in MI |
Note: Recombinant urokinase's pricing is not publicly established but is estimated to be in a similar range once commercial.
Projected Price for NDC 16571-0694:
- Initial Launch Price: Estimated USD 1,800 - 2,200 per dose—comparable to existing thrombolytics.
- Price Adjustments: Potential discounts or premiums are likely based on device/formulation, clinical data, and payer negotiations.
- Long-term Trends: Prices may decline by 10-15% annually post-market due to generic/biosimilar competition, which could develop approximately 8-12 years post-patent expiry.
What Are Future Market and Price Dynamics?
- Regulatory approval could catalyze market entry if the product demonstrates clear advantages over available options.
- Reimbursement policies could influence adoption. CMS reimbursement codes set at approximately USD 1,500, aligned with other thrombolytics, could impact profitability.
- Market penetration will depend heavily on clinical utility, safety profile, and physician acceptance.
Risks to Price and Market Projections
- Delayed approval or failure to gain approval reduces market potential.
- Competition from established thrombolytics and emerging biosimilars likely suppresses pricing power.
- Manufacturing costs may restrict initial pricing and profitability if production complexity results in higher costs.
Key Takeaways
- The product associated with NDC 16571-0694 is a recombinant urokinase, with limited commercial presence currently.
- Market revenue potential aligns with the USD 4.2 billion global thrombolytics sector, primarily driven by stroke and MI treatments.
- Estimated launch prices will mirror existing thrombolytics, around USD 1,800 - 2,200 per dose.
- Long-term pricing will decline with generic/biosimilar entry, likely by 10-15% annually.
- Market entry hinges on successful regulatory approval, manufacturing capability, and payer acceptance.
FAQs
Q1: When might recombinant urokinase expect FDA approval?
Approval timelines depend on clinical trial outcomes, but typically take 7-10 years from initial filing.
Q2: How does recombinant urokinase differ from marketed urokinase?
Recombinant versions are produced via DNA technology, potentially offering higher purity, consistency, and lower risk of pathogen transmission.
Q3: What are the main competitors for this drug?
Alteplase, reteplase, and tenecteplase dominate thrombolytic therapy markets with well-established reimbursement and clinical protocols.
Q4: What impact would biosimilar entry have on pricing?
Biosimilars generally reduce prices by 20-40%, accelerating market share and decreasing margins for innovator products.
Q5: How does the regulatory environment influence pricing?
Stringent approval processes can delay market entry and increase development costs, supporting higher initial prices. Reimbursement rates closely tie to clinical value and manufacturing costs.
Sources:
[1] FDA National Drug Code Directory, retrieved 2023.
[2] MarketResearch.com, "Thrombolytic Therapy Market Analysis," 2022.
[3] IQVIA, "U.S. Prescription Data," 2022.
