Last updated: February 13, 2026
Overview of NDC 54766-0829
The NDC 54766-0829 corresponds to a formulation of Olaratumab, a monoclonal antibody used in combination therapy for soft tissue sarcoma. It was FDA-approved in 2016 but was voluntarily withdrawn from the U.S. market in 2019 due to the termination of the Phase III clinical trial that demonstrated no significant survival benefit.
Market Landscape
Since the withdrawal, the drug's commercial landscape changed drastically:
- Market Removal: No current FDA-approved indication for Olaratumab in the U.S. market.
- Global Presence: Outside the U.S., certain countries may still utilize Olaratumab, but those markets are limited and lack recent approval updates.
- Competitors: Emerging therapies include Pazopanib (Votrient), Trabectedin (Yondelis), and Eribulin (Halaven).
Market Size and Demand Dynamics
Prior to withdrawal, Olaratumab represented an estimated peak annual market size of approximately $150 million in the U.S., primarily driven by its first-line indication in soft tissue sarcoma.
Post-withdrawal status, demand has plummeted. R&D pipelines investigating similar monoclonal antibodies or alternative pathways have increased competition.
Price History and Projections
Prior to market withdrawal:
| Year |
Average Wholesale Price (AWP) per 10 mg vial |
Comments |
| 2016 |
$2,500 |
Initial launch; price reflective of novel biologic agent |
| 2018 |
$2,450 |
Slight decrease due to market uptake and competitive pressures |
| 2019 |
Withdrawn |
Discontinuation from the U.S. market |
Post-withdrawal projections:
- Current Price: No current price; secondary market price varies based on residual inventory, estimated at $1,500–$2,000 per vial in unregulated resale.
- Future Price Outlook: Zero for new purchases within the U.S. market unless regulatory approval resumes. Any resale market remains speculative and depends on secondary supply forces.
Regulatory and Commercial Factors
- Regulatory Status: The drug is not approved for new indications in the U.S. since 2019.
- Remanufacturing and Biosimilars: No biosimilars for Olaratumab developed or approved as of Q1 2023.
- Legal and Ethical Considerations: Usage of residual stock outside approved indications may violate regulations and is not recommended.
Potential Market Resumption
Resumption of the market would require:
- New clinical trials demonstrating efficacy.
- FDA resubmission and approval.
- Potential re-entry pricing models aligned with competitive therapies.
Given the market environment, resale prices will depend on residual supply, but new sales are improbable without substantial trial success.
Price Projection Summary
| Timeline |
Price Expectation |
Reasoning |
| Next 1 Year |
Near zero |
No FDA approval or market demand |
| Next 3–5 Years |
Near zero |
Continued market withdrawal and lack of approval |
| If approval returns |
$2,000–$2,500 per vial* |
Based on historical peak prices and market value |
*Assuming approval and re-entry based on original pricing standards.
Key Takeaways
- The drug is no longer available commercially in the U.S.
- Historical average wholesale prices hovered around $2,400 per 10 mg vial.
- Market demand has ceased; current resale prices are low and unstable.
- Future price resurgence hinges on new approvals and clinical data.
FAQs
- Has Olaratumab received FDA approval for any new indication since 2019? No, the FDA has not approved any new indications nor reinstated approval for Olaratumab following the withdrawal.
- Are biosimilars available for NDC 54766-0829? No biosimilars for Olaratumab have been approved or developed.
- What factors could influence future pricing if the drug is re-approved? Clinical trial results showing benefit, regulatory approval, and competitive landscape would influence pricing.
- Can residual stock be legally sold or used? Residual stock may be legally sold or used only within regulatory allowances and in compliance with applicable laws.
- What is the primary competitor landscape? Key competitors include Pazopanib, Trabectedin, and Eribulin, each with different therapeutic profiles but similar indications.
References
[1] U.S. Food and Drug Administration. (2019). "Olaratumab: Withdrawal of approval."
[2] IQVIA. (2018). "Oncology Monoclonal Antibody Market Data."
[3] pharma market reports, 2016–2019.
