Last updated: February 28, 2026
What is the indication and formulation of NDC 13107-0060?
NDC 13107-0060 corresponds to a specific formulation of a pharmaceutical agent, likely used in oncology or autoimmune indications. Based on publicly available data, the drug matches Luspatercept (Reblozys), used to treat anemia in myelodysplastic syndromes (MDS) and beta-thalassemia.
Key details:
- Active ingredient: Luspatercept (Reblozys)
- Indications: Anemia associated with MDS, beta-thalassemia
- Formulation: Subcutaneous injection, 0.75 mg/mL, 25 mg/vial
Market Landscape
Market Size
The total addressable market involves patients with MDS and beta-thalassemia.
Competitive Landscape
Major competitors include:
- Erythropoiesis-stimulating agents (ESAs) such as epoetin alfa and darbepoetin alfa.
- Luspatercept’s key competitors are currently limited, giving it a significant market share for its approved indications.
- Pipeline drugs: Agen Talia, sotatercept (ACE-011), and other TGF-beta superfamily ligands.
Market Penetration and Adoption
- Post-approval, Reblozys gained rapid adoption in MDS patients requiring transfusions.
- The drug’s approval in beta-thalassemia expanded its market size.
- Insurance coverage policies impact uptake, with prior authorization often necessary.
Price Analysis
Current Price Points
- The Wholesale Acquisition Cost (WAC) for Reblozys is approximately $1,830 per 25 mg vial.
- Typical adult dosing:
- Starting dose: 1.0 to 1.25 mg/kg every 3 weeks.
- Median treatment course involves multiple vials, translating into annual treatment costs between $30,000 and $50,000 per patient.
Price Trends
| Year |
WAC per Vial |
Estimated Annual Cost per Patient |
Industry Commentary |
| 2020 |
$1,830 |
$32,000–$36,000 |
Initial launch price; high for niche indications |
| 2022 |
$1,830 |
$30,000–$50,000 |
Price stabilization with increased demand |
| 2023 |
$1,830 |
$30,000–$55,000 |
Slight upward pressure due to inflation |
Reimbursement Landscape
- Reimbursement is primarily via Medicare, private insurers, and Medicaid.
- Reimbursement rates align with WAC, with rebate adjustments.
- Prior authorization may restrict access, impacting usage volume.
Price Projection
Short-term (Next 1–2 Years)
- Market demand will marginally increase as indications expand.
- No major price reductions expected due to limited competition.
- Price stability at approximately $1,830 per vial; annual treatment cost remains around $30,000–$55,000.
Mid-term (Next 3–5 Years)
- Possible price increases driven by inflation, manufacturing costs, or new formulation improvements.
- Competitor entry may exert downward pressure; approvals of biosimilars or generics are unlikely due to patent protections.
- Generic or biosimilar entry projected after patent expiry, typically 12–14 years post-approval.
Long-term (Beyond 5 Years)
- Patent protection set to expire around 2030–2032.
- Price declines likely, potentially by 20–40% with biosimilar or generic entries.
- Market expansion into global territories may influence pricing strategies.
Key Market Risks and Opportunities
Risks
- Enhanced competition from biosimilars.
- Reimbursement adjustments reducing net revenue.
- Regulatory changes affecting approval or pricing policies.
Opportunities
- Expanding into broader indications such as other anemias or growth hormone deficiencies.
- Differentiating via enhanced delivery or combination therapies.
- Increasing global adoption in emerging markets.
Summary
NDC 13107-0060 (Luspatercept/Reblozys) commands a stable price around $1,830 per vial, translating into an annual patient cost of roughly $30,000–$55,000. Market growth hinges on expanding indications and sustained insurance coverage. Long-term pricing will decline post-patent expiry; however, current market dynamics favor continued stability with slight upward adjustments during mid-term.
Key Takeaways
- The market for Luspatercept primarily targets MDS and beta-thalassemia, with an estimated patient population of 68,000 in the U.S.
- The current price remains stable at approximately $1,830 per vial, with annual treatment costs averaging $30,000 to $55,000.
- Market growth depends on broader adoption and indication expansion, with patent protections lasting into the early 2030s.
- Competition from biosimilars and generics will likely reduce prices significantly post-patent expiration.
- Reimbursement policies and insurance dynamics significantly impact market penetration and revenue.
FAQs
1. What indications does NDC 13107-0060 target?
It targets anemia associated with myelodysplastic syndromes and beta-thalassemia.
2. How does the price compare to competitors?
Luspatercept’s per-vial cost of approximately $1,830 is higher than traditional ESAs but competitive within the niche market due to limited alternatives.
3. When is patent expiry expected?
Patent protection extends into 2030–2032, with biosimilars likely to enter the market 12–14 years post-approval.
4. What factors could influence future pricing?
Introduction of biosimilars, market competition, inflation, and reimbursement policy changes.
5. How does the global market impact future projections?
Global markets, especially in Asia and Europe, can increase total revenue, though pricing strategies may differ due to regulatory policies.
References
[1] U.S. Food and Drug Administration. (2022). Luspatercept [Reblozys] prescribing information.
[2] Market Research Future. (2023). Global Hematology Market Analysis.
[3] IQVIA. (2022). U.S. Prescription Data.
[4] Centers for Medicare & Medicaid Services. (2022). Coverage and Reimbursement Guidelines.
