Last updated: March 1, 2026
What is NDC 61990-0411?
NDC 61990-0411 corresponds to Teprotumumab-trbw, a monoclonal antibody indicated for the treatment of thyroid eye disease (TED). It is marketed under the brand name Tepezza by Horizon Therapeutics. Approved by the FDA in January 2020, this drug has expanded the therapeutic landscape for TED, a condition previously with limited treatment options.
Market Size and Demand for Tepezza
Prevalence of Thyroid Eye Disease
- TED affects approximately 25,000 to 50,000 patients annually in the U.S., with estimates indicating a prevalence of 16 per 100,000 people.
- It predominantly occurs in patients with Graves’ disease, affecting women more than men (ratio 4:1).
- The condition impacts quality of life due to symptoms like proptosis, double vision, and pain.
Market Penetration and Growth Trends
- Initial Launch (2020): Rapid uptake driven by lack of approved alternatives and high unmet need.
- 2022-2023: Growth plateaued as treatment uptake neared saturation within eligible populations.
- 2024 Projections: Steady increase driven by expanded indication labels and increasing awareness.
Estimated Market Penetration
- As of 2023, approximately 60% of eligible patients have received treatment.
- Projections estimate penetration reaching 75% by 2030, with annual new cases supplementing existing patient population.
Competitive Landscape
Key Competitors
- Limited competition exports for TED; no direct FDA-approved alternatives.
- Off-label treatments include corticosteroids and radiation therapy.
- Experimental therapies are in clinical development, but none are approved.
Market Differentiation
- First FDA-approved drug demonstrating disease modification.
- High efficacy, with clinical trials showing reduction in proptosis and disease activity scores.
- Requires intravenous administration every three weeks, which could affect accessibility.
Price Structure and Reimbursement Dynamics
Current Pricing
- Average Wholesale Price (AWP): Approximately $13,500 per infusion.
- Treatment Regimen: Typically 8 infusions over six months; total cost around $108,000 per patient.
- List Price: Estimated to be slightly lower considering discounts and rebates.
Reimbursement
- Reimbursed through Medicare, Medicaid, and private insurers.
- PBMs negotiate discounts; patient out-of-pocket costs vary based on insurance plans and coverage policies.
Price Trends and Projections
- Price was set at launch with limited discounts; some negotiations with payers have led to slight price reductions.
- Future price changes may be influenced by market competition, payer negotiations, and global market development.
Market Growth Drivers
- Increased awareness and diagnosis of TED.
- Expanded indication to include pre-treatment in patients with Graves’ orbitopathy.
- Potential for label expansion to related autoimmune orbitopathies.
Regulatory and Policy Factors
- FDA approval process completed in 2020.
- Ongoing discussions on pricing regulations, with some states considering measures to limit out-of-pocket costs for high-cost drugs.
- Price adjustments may follow policy shifts or inclusion in value-based care models.
Revenue Projections
| Year |
Estimated U.S. Sales |
Factors Influencing Revenue |
| 2023 |
$2.5 billion |
Saturated market, ongoing payer negotiations |
| 2024 |
$2.8 billion |
Slight price adjustments, increased awareness |
| 2025 |
$3.2 billion |
Broadened indication, expanded payer coverage |
| 2030 |
$4.0 billion |
Increased adoption, global expansion |
Opportunities and Risks
Opportunities
- Global expansion into European and Asian markets.
- Development of biosimilar versions reducing long-term costs.
- Label expansion for broader autoimmune orbital diseases.
Risks
- Entry of competing therapies, including novel biologics or small molecules.
- Reimbursement challenges due to high treatment costs.
- Regulatory hurdles affecting pricing or approval in foreign markets.
Key Takeaways
- NDC 61990-0411 (Tepezza) is a monoclonal antibody for TED with rapid market penetration since 2020.
- The U.S. market generated approximately $2.5 billion sales in 2023.
- List price per infusion is roughly $13,500, with the total treatment cost around $108,000.
- Market growth is driven by increasing diagnosis, expanded indications, and limited competition.
- Future revenue depends on payer negotiations, market expansion, and potential biosimilar entrants.
FAQs
1. When did Teprotumumab-trbw receive FDA approval?
In January 2020.
2. What is the typical treatment regimen for Tepezza?
It involves eight infusions administered every three weeks over approximately six months.
3. What is the estimated list price per infusion?
Approximately $13,500.
4. Are there any approved competitors for TED?
No; Tepezza remains the first and only FDA-approved therapy for TED as of 2023.
5. What is the outlook for biosimilars?
Biosimilars are potentially on the horizon, which could reduce long-term costs and improve access.
References
[1] Food and Drug Administration. (2020). FDA approves first treatment for thyroid eye disease.
[2] Horizon Therapeutics. (2023). Tepezza Prescribing Information.
[3] IQVIA. (2023). US Biopharmaceutical Market Dynamics.
[4] Centers for Disease Control and Prevention. (2022). Prevalence of thyroid eye disease.
[5] EvaluatePharma. (2023). Global pharma market projections.
