Last updated: February 27, 2026
What is NDC 51407-0615?
NDC 51407-0615 corresponds to Teprotumumab-trbw (Tepezza), an FDA-approved monoclonal antibody for the treatment of thyroid eye disease (TED). Approved in January 2020, it is marketed by Horizon Therapeutics.
Market Size Estimates
Incidence and Prevalence
- Thyroid eye disease (TED) affects approximately 0.02% to 0.03% of the global population, with higher prevalence among patients with Graves' disease.
- In the U.S., an estimated 50,000 to 80,000 patients have active TED.
Market Penetration
- Initial adoption was slow, over 2,000 patients treated nationally in 2020.
- Sales grew sharply, with approximately $800 million in 2021 and exceeding $1 billion in 2022.
- Projected to reach $1.5 billion to $2 billion annually by 2025, assuming continued growth and expanded indications.
Competitive Landscape
- No direct biosimilar currently marketed.
- Off-label treatments include corticosteroids, orbital decompression surgery, and radiotherapy.
- Tepezza remains the only FDA-approved option for active TED.
Price Analysis
List Price
- The published list price for a 6 mg/0.55 mL vial is approximately $12,000.
- Treatment regimen: 8 infusions over 22 weeks, totaling $96,000 per patient.
Actual Market Price
- Reimbursement rates often vary due to discounts, pharmacy benefit manager (PBM) negotiations, and patient assistance programs.
- Estimated net price per infusion varies from $7,000 to $10,000 after discounts.
Cost per Treatment Course
- Total treatment cost: $56,000 to $80,000 per patient, varying by negotiated discounts and patient assistance.
Price Projections
| Year |
Estimated Average Price per Infusion |
Total Course Cost |
Market Penetration Assumptions |
| 2023 |
$9,000 |
$72,000 |
15,000 patients treated |
| 2024 |
$9,500 |
$76,000 |
20,000 patients treated |
| 2025 |
$10,000 |
$80,000 |
25,000 patients treated |
Factors Affecting Price Developments
- Pricing pressures: Payer negotiations, biosimilar development, and market saturation.
- Expanded indications: Potential approval for other autoimmune disorders could increase demand.
- Reimbursement policies: Changes in CMS and private payers could influence net prices.
Regulatory and Reimbursement Context
- FDA approval in January 2020 for active TED.
- Medicare and private insurers generally reimburse based on established coding and pricing, with some variability.
- Horizon Therapeutics maintains a patient assistance program, which can impact out-of-pocket costs.
Strategic Considerations
- The market is driven by the limited number of approved therapies for TED.
- Competition from off-label therapies poses a barrier but has limited efficacy.
- As awareness increases, market penetration could accelerate, putting upward pressure on prices initially, followed by potential stabilization or slight decline due to market saturation and biosimilar entry.
Key Takeaways
- The current market for NDC 51407-0615 (Tepezza) is around $1 billion annually.
- The list price per treatment course averages $96,000, but negotiated net prices are estimated lower.
- Market growth depends on the expansion of approved indications, payer acceptance, and potential biosimilar development.
- Price per infusion is projected to increase from $9,000 to $10,000 through 2025, aligned with increased market penetration.
FAQs
1. Will biosimilars emerge for Tepezza?
No biosimilars are currently approved, but biosimilar development for monoclonal antibodies is active, though regulatory hurdles and patent protections could delay entry.
2. How does payer coverage impact pricing?
Payer negotiations can reduce net costs significantly, especially as the patient population expands, influencing overall market revenue.
3. Are there any expanded indications for Tepezza?
Research is ongoing for additional autoimmune conditions, but FDA approval currently applies solely to TED.
4. What are the main drivers of market growth?
Growing prevalence, increased awareness, and expanded treatment guidelines contribute to market expansion.
5. How does the treatment cost compare to alternatives?
Tepezza's cost remains higher than off-label corticosteroid therapy but offers a targeted, non-invasive treatment compared to surgical options.
Sources
[1] U.S. Food and Drug Administration. (2020). FDA approves teprotumumab-trbw for thyroid eye disease. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-teprotumumab-trbw-thyroid-eye-disease
[2] Horizon Therapeutics. (2022). Tepezza Pricing and Patient Assistance. Retrieved from https://www.horizontherapeutics.com/products/tepezza
[3] EvaluatePharma. (2022). Market forecasts for Tepezza. Retrieved from https://www.evaluate.com/ (subscription required)
[4] IQVIA. (2022). Market Data for Biologics and Rare Disease Treatments.
