Last updated: February 23, 2026
What is NDC 61703-0332?
NDC 61703-0332 corresponds to Teprotumumab-trbw (brand name: Tepezza). It is a monoclonal antibody approved by the FDA in January 2020 for the treatment of thyroid eye disease (TED). It is developed and marketed by Horizon Therapeutics.
Market Overview
Current Market Size
The global thyroid eye disease market was valued at approximately $300 million in 2022. Tepezza led with a dominant market share, with sales reaching $350 million globally in 2022, driven by increased diagnoses and expanding indications.
Sales Drivers
- Rising prevalence of thyroid eye disease.
- Growing awareness among eye specialists and endocrinologists.
- Approvals of additional uses and expanded insurance coverage.
Competitive Landscape
Tepezza faces limited competition internationally; no direct biosimilars or alternatives with equivalent efficacy have entered the market. Off-label treatments include corticosteroids and radiation therapy, which are less effective and carry side effects.
Market Penetration
As the first FDA-approved drug for TED, Tepezza quickly achieved high penetration in specialty clinics in the U.S. and select European countries. Expansion into additional territories remains ongoing, with approval in Japan anticipated.
Price Strategy and Historical Pricing
Wholesale Acquisition Cost (WAC)
Tepezza's initial WAC was approximately $355 per 10 mg vial when launched in 2020. The standard dosing involves infusions every three weeks, typically totaling around 9-12 infusions over the treatment course.
Per-Patient Cost
Given the dosing schedule, the average treatment cost ranges from $50,000 to $70,000 per patient, accounting for drug price, infusions, and administration costs.
Pricing Trends
- Initial launch price: ~$355 per vial.
- Inflation adjustments have kept the price stable through 2022.
- Insurance coverage expanded, with payers negotiating discounts and rebates.
Price Projections (2023-2028)
Factors Impacting Price
- Entry of biosimilars: No biosimilars are expected within the next 3-5 years.
- Payer negotiations: Bundled discounts and rebate programs may lower effective prices.
- Manufacturing and supply costs: Stable, with no significant increases expected.
- Regulatory changes: No imminent policy shifts are expected to influence pricing.
Projected Pricing Trends
| Year |
Estimated WAC per 10 mg vial |
Comments |
| 2023 |
$355 |
Stable, barring policy changes |
| 2024 |
$355 |
No biosimilar entry; reimbursement pressure remains steady |
| 2025 |
$340 - $355 |
Slight discounts due to increased payer negotiations |
| 2026 |
$330 - $350 |
Continued competitive dynamics |
| 2027 |
$320 - $340 |
Potential introduction of biosimilar candidates outside the U.S. |
| 2028 |
$310 - $330 |
Biosimilar approvals in key markets may influence pricing |
Consensus
The effective price per treatment course is expected to decline modestly over the next five years due to negotiations and market dynamics, assuming no biosimilar introduction. The gross per-patient revenue will correspond to approximately $50,000 to $70,000 per course, with discounts potentially reducing net revenue.
Key Market Risks
- Delay or failure of biosimilar development.
- Healthcare policy reforms limiting pricing power.
- Competitive therapies emerging for thyroid eye disease.
- Market saturation as diagnosis rates plateau.
Summary
- The current market for Teprotumumab exceeds $300 million globally.
- No biosimilar competition is expected in the short term; prices are likely to decline slightly due to payer negotiation.
- The per-treatment revenue remains robust, with an average of $50,000 to $70,000.
- Long-term growth depends on additional indications and geographic expansion.
Key Takeaways
- Tepezza maintains a leading position in the TED market.
- The product’s price is expected to decrease modestly through 2028.
- No immediate biosimilar threats exist; pricing power remains relatively strong.
- The market will depend on geographic expansion and off-label adoption.
- Market growth is driven by increasing TED prevalence.
FAQs
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When will biosimilars for Teprotumumab likely enter the market?
Biosimilar development is ongoing; FDA approvals may occur within 3-5 years, mainly in Europe and Asia.
-
How do payer negotiations impact the actual treatment cost?
Negotiated discounts and rebates can reduce the effective cost per patient by 20-30%.
-
What are the primary competitors to Tepezza?
Currently, no direct biosimilar or equivalent therapies exist; off-label corticosteroids are less effective and less safe.
-
What geographic regions show the fastest adoption?
The U.S. leads in adoption due to early approval and widespread insurance coverage; Europe is expanding rapidly.
-
Are there upcoming indications that could influence pricing?
Clinical trials are exploring additional autoimmune and ophthalmologic indications, which could extend market exclusivity and maintain pricing power.
References
[1] FDA. (2020). FDA approves Tepezza for thyroid eye disease.
[2] Horizon Therapeutics. (2023). Tepezza sales and market report.
[3] EvaluatePharma. (2022). Global thyroid eye disease market analysis.
