Last updated: July 30, 2025
Overview of NDC 62011-0341
NDC 62011-0341 corresponds to Rovalpituzumab Tesirine (Rova-T), a bi-specific antibody-drug conjugate developed by AbbVie and Takeda aimed at targeting DLL3 in small-cell lung cancer (SCLC) and other neuroendocrine tumors. Originally pursued for treatment-resistant SCLC, Rova-T experienced a complex development trajectory, with pivotal clinical trials failing to demonstrate significant survival benefits, leading to its discontinuation. Despite halts in clinical development, understanding its market context remains relevant due to residual intellectual property, stockpiling, or potential off-label use.
Market Context and Clinical Landscape
The therapeutic market for SCLC is highly specialized, characterized by limited treatment options. Traditionally, this includes:
- Chemotherapy (etoposide with platinum compounds)
- Immunotherapy (e.g., atezolizumab, durvalumab)
Novel targeted agents like Rova-T aimed to address unmet needs for more effective therapies. Its initial promise and subsequent clinical setbacks reflect the high-risk, high-reward nature of oncology drug development.
In terms of market dynamics:
- The initial FDA orphan drug designation and accelerated approval pathways created optimism.
- Phase II and III trial results for Rova-T were underwhelming, resulting in a significant downtick in commercial prospects.
- Market exit strategies and patent expirations diminish near-term revenue potential, yet residual demand may persist for specific niche uses or off-label contexts.
Market Size and Segmentation Analysis
1. Total Addressable Market (TAM):
Based on the incidence of small-cell lung cancer—approximately 30,000 new cases annually in the U.S. (as per GLOBOCAN and SEER data)—and the proportion of patients with extensive-stage disease suitable for novel therapies (~70%), the TAM roughly estimates at:
- U.S. Market: 20,000 patients/year
- Global market: 150,000–200,000 patients/year
2. Current Market Penetration:
Given the drug’s clinical failure and lack of approval, direct outpatient sales are negligible. However, the potential residual demand can be sourced from:
- Off-label use in compassionate settings
- Parallel imports or legal gray markets in regions like China and Europe
- Potential reuse in phase 2 studies or as a research reagent
3. Competitive Landscape:
Rova-T faced competition from:
- Standard chemotherapies: Etoposide, cisplatin, carboplatin
- Immunotherapies: Atezolizumab, durvalumab (standard-of-care in many settings now)
- Emerging targeted agents: Other DLL3-targeted therapies, such as Tarextumab
Given these, Rova-T’s market share is expected to be minimal, with primary value now in residual demand or exclusive licensing agreements.
Regulatory and Patent Considerations
- Regulatory status: Discontinued in late-stage development; no latest FDA approval.
- Patent landscape: Key patents on antibody conjugates and DLL3 targeting expire between 2025 and 2030, potentially opening opportunities for generics or biosimilars if reinitiated.
- Liability: Limited legal risk due to no current approval, reducing market entry barriers but also limiting economic upside.
Price Projection Methodology
Given the drug's discontinued status, modeling price projections involves multiple assumptions:
-
Residual Market Price:
If residual demand persists for off-label use or research, prices could range from $1,000 to $5,000 per dose based on similar niche oncology products [1].
-
Potential Licensing or Reintroduction:
In hypothetical reactivation scenarios, prices would likely align with current targeted therapies:
- $10,000 to $15,000 per dose for a typical treatment cycle, matching other antibody-drug conjugates.
- Market Share Estimations:
Assuming a conservative 1–2% of the TAM with off-label demand, revenues could be in the $20–$50 million annually in niche markets, translating into unit prices adjusted for distribution.
Forecasting Price Trends (2023–2030)
| Year |
Estimated Price Range (per dose) |
Remarks |
| 2023 |
$1,000–$5,000 |
Existing residual demand, off-label use. |
| 2025 |
$1,000–$3,500 |
Decline due to patent expiry pressures and competition. |
| 2027 |
$1,000–$2,500 |
Market saturation, entry of biosimilars or generics. |
| 2030 |
$1,000–$2,000 |
Further price erosion; niche applications persist. |
Risk Factors Influencing Market and Pricing
- Regulatory developments: Any revival hinges on new clinical trials or alternative indications.
- Patent expirations: Open avenues for generics; expected around 2025–2027.
- Competitive innovation: Emergence of more effective therapies reduces residual demand.
- Market acceptance: Off-label use depends on clinician confidence, reimbursement, and safety profiles.
Conclusion and Strategic Implications
While NDC 62011-0341’s active development lifecycle has halted, its residual market potential and niche applications justify a cautious, adaptive pricing approach. If revived or repurposed, pricing could mirror current targeted oncology therapeutics, ranging between $10,000 and $15,000 per dose. Short-term projections favor stabilization with a potential decline driven by patent expirations and competitive advances.
Key Takeaways
- NDC 62011-0341 (Rova-T) no longer holds active market authorization, limiting direct sales.
- Residual demand derives mainly from off-label use and niche markets, supporting modest pricing—$1,000–$5,000 per dose.
- Market prospects hinge on regulatory decisions, patent statuses, and competitive landscape shifts.
- Prospective reintroduction or licensing could reposition Rova-T within the high-value targeted therapy segment.
- Continuous monitoring of patent expirations, clinical trial results, and emerging therapies is critical for accurate market and price forecasting.
FAQs
1. Is NDC 62011-0341 currently approved for any clinical use?
No. Rova-T was discontinued after failing to demonstrate significant clinical benefits in phase III trials; it has no current FDA approval.
2. Can residual demand sustain meaningful revenue for the drug?
Residual demand is limited, primarily driven by off-label use, research, or niche indications. Revenue projections remain modest accordingly.
3. How do patent expirations impact future pricing?
Patent expirations around 2025–2027 may lead to biosimilar entry, pressuring prices downward and expanding generic competition.
4. Are there any regulatory pathways to revive or repurpose the drug?
Potential pathways include orphan drug designation or investigational new drug (IND) applications for different indications, but none are currently active.
5. What emerging therapies could impact the market for drugs like Rova-T?
Emerging targeted therapies and immunotherapies (e.g., DLL3-targeted agents, novel checkpoint inhibitors) pose competitive threats, likely reducing residual value.
References
[1] IQVIA. (2022). The Global Use of Medicines Report.
[2] SEER Program. (2021). Source of Cancer Statistics.
[3] GLOBOCAN. (2020). Cancer Fact Sheets.
