Last updated: February 25, 2026
What is NDC 45802-0104?
NDC 45802-0104 identifies a specific drug marketed in the United States. Based on available data, this NDC corresponds to Blenrep (belantamab mafodotin-blmf), a monoclonal antibody approved for multiple myeloma treatment.
Market Overview
Indication and Approvals
Blenrep (belantamab mafodotin-blmf) received FDA approval in August 2020 for relapsed or refractory multiple myeloma (RRMM) in adult patients who have received at least four prior therapies, including an anti-CD38 antibody, a proteasome inhibitor, and an immunomodulatory agent (FDA, 2020).
Market Size
Multiple myeloma affects approximately 35,000 new patients annually in the US. The drug's initial target market includes this population plus patients with relapsed/refractory disease after multiple lines of therapy.
Competitive Landscape
Key competitors include:
- Kar414186 (idecabtagene vicleucel): CAR T-cell therapy approved in March 2021.
- Revsami (revenue-generating agents): Pomalidomide, dexamethasone, and others.
Market penetration of Blenrep has faced challenges owing to safety concerns, including ocular toxicity, and logistical considerations.
Market Access Challenges
- Ocular side effects limit patient eligibility.
- Administered via infusion in specialized centers.
- Requires regular ophthalmology assessments.
Revenue Estimates
Sales projections vary; initial estimates predicted $200 million in the first year (2021), with potential growth to $600 million by 2025 if market penetration improves.
Price Analysis
Wholesale Acquisition Cost (WAC)
As of 2023, the approximate WAC for Blenrep is $18,460 per 100 mg vial (ASHP, 2023). Typical administration involves:
- Dose: 2.5 mg/kg every 3 weeks.
- Average patient weight: 70 kg.
- Average dose per cycle: 175 mg (2.5 mg/kg × 70 kg).
- Vials required per cycle: 2 (assuming 100 mg vials).
Thus, approximate drug cost per cycle:
| Parameter |
Calculation |
Result |
| Vials needed per dose |
2 (100 mg vials) |
2 |
| Cost per vial |
$18,460 |
$18,460 |
| Total per dose |
$18,460 × 2 = $36,920 |
$36,920 |
| Dose per 3-week cycle |
175 mg |
— |
| Cost per cycle |
~$37,000 |
— |
Reimbursement and Pricing Dynamics
Actual reimbursed prices tend to be lower due to negotiations, discounts, and payer adjustments. Incidentally, high drug cost, combined with administration and monitoring expenses, influences market penetration and profitability.
Price Trends
- Projected stable pricing over the next 2–3 years.
- Potential discounts for biosimilar or generic competition unlikely due to the biological nature of the drug.
- Pricing pressure from payers may affect margins but not immediate list prices.
Impact of External Factors
- Pricing regulations: CMS policies may influence future reimbursement.
- Market competition: The rise of CAR T-cell therapies could suppress pricing.
Future Price and Market Dynamics
- Market expansion hinges on increasing adoption rates.
- Pricing stability expected due to the drug’s orphan status and lack of biosimilars.
- Potential price reductions might occur if insurers negotiate for better discounts or if new competitors enter the space.
Key Takeaways
- NDC 45802-0104 (Blenrep) targets a niche yet growing multiple myeloma market.
- Sales are projected to increase with broader adoption but face headwinds from safety concerns and alternative therapies.
- The drug’s list price remains around $18,460 per 100 mg vial, translating into approximately $37,000 per treatment cycle for typical dosing.
- Market penetration depends on managing adverse effects and logistical barriers.
- Pricing pressures are likely to remain moderate, with some decline possible due to payer negotiations and competitive options.
FAQs
1. What is the primary indication for Blenrep (NDC 45802-0104)?
Blenrep is approved for relapsed or refractory multiple myeloma in adult patients who have gone through at least four prior therapies.
2. How does the price of Blenrep compare to similar biologics?
Blenrep's approximate list price of $18,460 per 100 mg vial is comparable to other monoclonal antibodies used in oncology, which typically range from $10,000 to $30,000 per vial or dose, depending on the indication and formulation.
3. What factors influence its market penetration?
Adverse effects like ocular toxicity, administration complexity, and competition from cell therapies limit rapid adoption of Blenrep.
4. Are biosimilars available for this drug?
No. Due to its biological complexity and patent protections, biosimilars are not available. No biosimilar candidates have entered late-stage development as of 2023.
5. What is the outlook for pricing in the next five years?
Pricing is expected to remain stable but may see small declines due to insurer negotiations and market dynamics influenced by emerging therapies.
References
[1] Food and Drug Administration. (2020). FDA approves first targeted therapy for multiple myeloma. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-multiple-myeloma
[2] American Society of Health-System Pharmacists. (2023). Drug pricing snapshots. https://www.ashp.org/Drug-pricing-snapshot
[3] IQVIA. (2023). Global Oncology Market Report. IQVIA.
