Last updated: February 13, 2026
Overview
NDC 60846-0812 is identified as Olaratumab (Lartruvo), a monoclonal antibody developed for soft tissue sarcoma, now withdrawn from the U.S. market. The drug was marketed by Eli Lilly and received FDA approval in 2016 but was withdrawn in 2019 after failing to demonstrate clinical benefit in a phase 3 trial.
Market Context
Market Segmentation:
- Primary indication: Soft tissue sarcoma.
- Patient population: Approximately 8,000-10,000 cases diagnosed annually in the U.S. prior to withdrawal.
- Competitive landscape: Limited, with options including doxorubicin, ifosfamide, and experimental therapies; no direct competitors since withdrawal.
Market Factors:
- Regulatory status: Market withdrawal in the U.S. limits commercial potential.
- Global landscape: Limited data on approval outside the U.S.; other markets have not widely adopted the drug.
- Reimbursement environment: Insufficient coverage post-withdrawal impacts price stability.
Historical Pricing and Sales Data
Estimated Launch Price (2016):
- Approximately $11,000 per 460 mg vial.
- Dosing: 15 mg/kg every three weeks.
Sales Data:
- Yearly U.S. sales peaked at roughly $50 million in 2017.
- Post-2018, sales declined rapidly following clinical trial results.
Market Outlook and Price Projections
Current Status:
The drug is no longer commercially available in the U.S. due to market withdrawal. However, potential reintroduction could occur if new approvals or international markets recognize ongoing clinical development.
Projection Scenarios:
| Scenario |
Assumptions |
Price Range (per vial) |
Notes |
| High |
Market re-enters post-approval with clinical support |
$8,000 - $12,000 |
Based on original per-vial pricing adjusted for inflation. |
| Moderate |
Limited approval, niche market, no significant competition |
$5,000 - $8,000 |
Accounting for market constraints and reduced demand. |
| Low |
No market re-entry, generic emergence or substitute therapies dominate |
<$2,000 |
Price collapse due to generic biosimilar pressure. |
Key Factors Influencing Pricing:
- Regulatory approval status: Without FDA approval, pricing remains theoretical.
- Clinical trial outcomes: Future trials could revive interest, influencing pricing.
- Reimbursement policies: Insurance coverage impacts achievable prices.
- International markets: Approval in other countries could raise overall market size.
Potential Commercial Strategies
- Market re-entry: Requires new clinical data affirming efficacy.
- Partnerships: Collaborations with biotech firms to explore new indications.
- Global expansion: Focus on countries with ongoing clinical trials or regulatory pathways.
Summary
The discontinuation of NDC 60846-0812 in the U.S. limits immediate market potential. Prices historically hovered around $11,000 per vial. Future projections hinge on regulatory development, clinical trial outcomes, and international acceptance. Currently, prices remain speculative without ongoing approvals or commercial activity.
Key Takeaways
- NDC 60846-0812, Olaratumab, was withdrawn from the U.S. market post-2019.
- Peak sales reached approximately $50 million annually in the U.S. prior to withdrawal.
- Price per vial historically was approximately $11,000; future prices depend on regulatory and clinical developments.
- No current market activity limits revenue, but international opportunities exist.
- Re-entry into the U.S. market would require substantial clinical validation and regulatory approval.
FAQs
1. Why was Olaratumab withdrawn from the U.S. market?
It was withdrawn because a phase 3 trial failed to demonstrate a survival benefit for patients with soft tissue sarcoma, making continued marketing unviable.
2. Is Olaratumab approved outside the U.S.?
There is limited information about approval outside the U.S.; some markets may have considered it, but widespread approval has not been documented.
3. How does the pricing of biologics like Olaratumab compare to other monoclonal antibodies?
Prices are generally similar, ranging from $8,000 to $15,000 per vial, but depend on indication, dosing, and negotiated reimbursement rates.
4. What factors could lead to a relaunch of Olaratumab?
New clinical data indicating efficacy, regulatory approval in other countries, or new indications could trigger a market re-entry.
5. What is the impact of biosimilars on Olaratumab’s market?
A biosimilar could reduce prices significantly, pushing per-vial costs below $2,000, but none are currently on the market due to the drug's withdrawal.
References
[1] FDA. “Lartruvo (olaratumab) approval;” 2016.
[2] Eli Lilly, Annual Report 2018.
[3] Evaluate Pharma. “Biologic pricing benchmarks,” 2022.
[4] NCI SEER Program. “Soft tissue sarcoma statistics,” 2020.
[5] ClinicalTrials.gov. “Olaratumab clinical trials,” 2022.
