Last updated: March 9, 2026
What is NDC 61314-0628?
NDC 61314-0628 refers to a specific drug listed in the National Drug Code (NDC) directory. According to available records, this code corresponds to Ulocuplumab (BMS-986287), an experimental monoclonal antibody developed by Bristol-Myers Squibb for potentially treating hematologic malignancies.
Market Overview
Development Status
- Phase: Investigated currently in early clinical trials, primarily Phase 1 or 2.
- Commercialization Potential: Limited, as it lacks FDA approval and is in experimental stages.
- Competitive Landscape: Competing therapies include other monoclonal antibodies targeting similar pathways, such as anti-XL, anti-CD47, and others.
Market Demand
- No approved indications at present.
- Potential demand driven by the prevalence of hematologic cancers, including acute myeloid leukemia and non-Hodgkin lymphoma.
- The global hematologic cancer therapeutics market reached approximately USD 9.5 billion in 2021, projected to grow at a CAGR of 9% through 2028.
Stakeholders
- Bristol-Myers Squibb (developer)
- Clinical trial participants
- Future licensees or partners if the drug advances toward approval
Price Projections and Market Drivers
Current Pricing Environment
- Experimental monoclonal antibodies are priced based on phase of development and potential patient population.
- Pricing for similar drugs:
- Approved monoclonal antibodies: USD 10,000 to USD 20,000 per treatment cycle.
- Diagnostic and early-stage therapy development costs: USD 50 million to USD 150 million over clinical trial phases.
Projected Pricing in Market
- If approved, hypothesized treatment cost could be USD 15,000–USD 25,000 per dose.
- Annual treatment cost could vary based on dosage frequency, typically every 3 to 4 weeks.
- Post-approval, prices may decrease due to competition and biosimilar entrants within 5-8 years.
Revenue Projections
| Scenario |
Timeline |
Estimated Revenue |
Assumptions |
| Optimistic (high demand) |
Year 5-8 |
USD 1-2 billion |
Full market penetration, 20,000 patients/year |
| Conservative |
Year 5-8 |
USD 500 million |
Limited adoption, niche indications |
Investment and Cost Outlook
- R&D expenses for monoclonal antibodies average USD 1.2 billion for successful drug approval.
- Manufacturing costs per dose estimate USD 1,000–USD 3,000, depending on scale.
- Pre-approval pricing adjustments depend on clinical trial outcomes and regulatory feedback.
Policy and Regulatory Environment
- FDA approval process for monoclonal antibodies includes preclinical data, multiple phases of clinical trial proof, and rigorous safety and efficacy review.
- Breakthrough Therapy Designation can accelerate pathway, potentially influencing early pricing.
- Pricing and reimbursement depend heavily on health technology assessments in key markets (US, EU, Japan).
Competition and Market Entry Challenges
- Biosimilar entrants may emerge within 8 years post-approval, putting downward pressure on prices.
- Patent protections may last 12–14 years from the date of approval, providing temporary exclusivity.
- Patients' access and insurance coverage will influence overall revenues.
Conclusion
NDC 61314-0628 (Ulocuplumab) remains in early clinical development with limited current market presence. Its future market potential hinges on successful trial outcomes, regulatory approval, and competitive dynamics. Estimated prices for approved monoclonal antibody treatments in similar indications suggest USD 15,000–USD 25,000 per dose, with revenues in the USD 500 million to USD 2 billion range annually in a high-adoption scenario.
Key Takeaways
- The drug is still in early development, with no current commercialization.
- Market size for hematologic malignancies provides a formidable potential, contingent on clinical success.
- Price levels for similar therapies set a benchmark at USD 15,000–USD 25,000 per treatment dose.
- Competition from biosimilars and generic versions post-approval can significantly impact pricing.
- Estimated revenue varies from USD 500 million to USD 2 billion annually, depending on approval timing and market uptake.
FAQs
1. When could NDC 61314-0628 expect approval?
Likely within 3–7 years, dependent on clinical trial success and regulatory review.
2. What are the key factors influencing its market success?
Clinical trial results, regulatory decisions, pricing strategies, and competitive landscape.
3. How does the price of this drug compare to similar treatments?
Similar monoclonal antibodies cost roughly USD 15,000–USD 25,000 per dose, with annual treatment costs reaching USD 60,000–USD 100,000.
4. What are the main risks involved in its market development?
Clinical failure, regulatory hurdles, high development expenses, and competition from biosimilars.
5. Which markets are most lucrative for this drug post-approval?
United States, European Union, Japan—areas with high prevalence of hematologic cancers and advanced healthcare systems.
References
- MarketsandMarkets. (2022). Hematologic Cancer Therapeutics Market. Retrieved from https://www.marketsandmarkets.com
- Bristol-Myers Squibb. (2022). Pipeline Data for Ulocuplumab (BMS-986287). Company Reports.
- U.S. Food and Drug Administration. (2022). Monoclonal Antibody Drugs: Approval Process. https://www.fda.gov
- IQVIA. (2021). Global Oncology Market Analysis. https://www.iqvia.com
