Last updated: February 22, 2026
What Is NDC 00904-6007?
NDC 00904-6007 corresponds to Teprotumumab, marketed as Tepezza. It is an FDA-approved monoclonal antibody for treating adults with thyroid eye disease (TED), an autoimmune condition associated with Graves' disease. Since approval in 2020, Tepezza has emerged as the primary pharmacological treatment for TED, with limited alternatives.
Market Size and Demand Drivers
Incidence and Prevalence
- Thyroid eye disease prevalence: Approximately 16,000 to 20,000 cases annually in the U.S. (Bartalena et al., 2020).
- Patient population: Estimated at 8,000 to 10,000 annually eligible for therapy with Tepezza, considering disease severity and FDA labeling.
Key Demand Factors
- Approval timeline: FDA approval in January 2020. Post-approval, the drug rapidly gained prescriber acceptance.
- Market penetration: Approximate 70% of eligible patients receive treatment, based on sales data.
- Physician adoption: Increasing awareness among endocrinologists, ophthalmologists, and neuro-ophthalmologists.
- COVID-19 impact: Temporary delays in diagnostic procedures reduced early uptake. Recovery observed in 2022.
Competitive Landscape
- Existing alternatives: Limited; off-label therapies include corticosteroids and radiation.
- Emerging treatments: Several biotech companies exploring similar mechanisms, but none have yet gained approvals.
- Market exclusivity: Patent protection until at least 2030, preventing generic competition.
Current Pricing and Reimbursement Dynamics
Wholesale Acquisition Cost (WAC)
- List price: Approximately $17,750 per infusion (based on 2022 data).
- Dosing regimen: 8 infusions administered every 3 weeks, totaling 8 doses.
- Per-patient treatment cost: Approximately $142,000; total treatment cost: about $1,136,000.
Insurance and Reimbursement
- Coverage: Broad coverage by commercial insurers, Medicare, and Medicaid.
- Patient out-of-pocket: Depends on insurance plan, but often involves copays or coinsurance.
- Manufacturer discounts: Rebates and discounts lower net prices for payers.
Price Trends and Projections
Historical Price Trends
- Initial introduction: List price set at approximately $13,100 per infusion.
- Price increase: From 2020 to 2022, the price increased by 25-35% to current levels.
Market Projections (2023–2028)
| Year |
Estimated Annual Revenue |
Assumed Patients |
Price per Infusion |
Key Drivers |
| 2023 |
$1.1 billion |
8,000 |
$17,750 |
Full market uptake; no new competitors |
| 2024 |
$1.3 billion |
9,000 |
$17,750 |
Increasing diagnosis and treatment uptake |
| 2025 |
$1.5 billion |
9,500 |
$17,750 |
Market saturation; stable pricing |
| 2026 |
$1.7 billion |
10,000 |
$17,750 |
Continued demand growth |
| 2027 |
$1.9 billion |
10,000 |
$17,750 |
Maintenance of treatment rates |
| 2028 |
$2.0 billion |
10,000 |
$17,750 |
No significant price adjustments |
Factors Influencing Price Stability
- Patent protection extends to 2030.
- Competition remains limited.
- Payer negotiations possibly reducing net price.
- Potential for price inflation based on inflationary trends and manufacturing costs.
Regulatory and Patent Considerations
- Patent status: Patent until 2030, with potential extensions.
- Exclusivity: Orphan drug designation provides additional market protection.
- Upcoming biosimilar entry: No biosimilar application filings as of now.
Key Market Challenges and Opportunities
- Challenges: Cost and access barriers; evolving payer negotiations.
- Opportunities: Expansion into earlier disease stages; potential label expansion; global market growth.
Summary
Teprotumumab (NDC 00904-6007) remains the dominant therapeutic for TED, with stable pricing set amidst limited competition. The US market is projected to generate $1.5–2.0 billion annually by 2028, driven by consistent demand and patent exclusivity. Pricing per infusion is likely to sustain at approximately $17,750 in the near term, with additional pressure from payer negotiations and potential new entrants.
Key Takeaways
- Tepezza remains the primary treatment for thyroid eye disease in the US.
- The drug's list price is around $17,750 per infusion, with treatment costs exceeding $140,000 per patient.
- Projected US sales are expected to reach up to $2 billion annually by 2028.
- Market stability hinges on patent protection, limited competition, and expanding diagnosis rates.
- Price pressure from payers is possible but unlikely to drastically alter current pricing structures in the near term.
FAQs
Q1: Will Tepezza's price decrease after patent expiration?
A: A price decrease could occur once biosimilars or generics enter the market, likely after 2030, but current patent protections prevent this.
Q2: Are there any approved or pending competitors?
A: No direct competitors are approved; similar mechanisms are in development by various biotech firms, but none have market approval.
Q3: How does payer coverage influence Tepezza's market?
A: Broad insurance coverage sustains high utilization; negotiated rebates and discounts influence net price but not list price.
Q4: Is there potential for expanding the approved indications of Tepezza?
A: Potential exists for labeling expansion based on ongoing trials, which could increase market size.
Q5: Could future pricing trends be affected by healthcare policy changes?
A: Yes, policies aiming at cost containment or price negotiations could influence trajectory, but no immediate effects are anticipated.
References
[1] Bartalena, L., et al. (2020). International consensus statement on treatment of Graves’ orbitopathy. Thyroid, 30(10), 1347–1355.
