Last updated: February 25, 2026
What is NDC: 51407-0042?
NDC 51407-0042 refers to Teprotumumab-trbw, a monoclonal antibody marketed under the brand name Tepezza. Approved by the FDA in January 2020 for the treatment of Thyroid Eye Disease (TED), also known as Graves' orbitopathy. It is indicated for adults with active, moderate to severe TED.
Market Overview
Market Size and Demand
The global market for thyroid eye disease treatments is evolving. Prior to Tepezza’s approval, management relied on steroids, surgical interventions, and off-label use of other immunosuppressants.
Prevalence estimates:
- Estimated prevalence of TED among Graves' disease patients: approximately 30% (Smith et al., 2017).
- Graves' disease affects about 1% of the U.S. population (~3 million individuals).
- About 0.3 million patients in the U.S. could have symptomatic TED.
Key Market Drivers
- FDA approval in 2020 provided a targeted therapy for TED.
- Growing awareness among endocrinologists and ophthalmologists.
- Increasing diagnosis of Graves' disease and related orbitopathy.
- High unmet medical need for effective, non-invasive treatments.
Competitive Landscape
| Product |
Indication |
Approval Year |
Market Share |
Notes |
| Teprotumumab |
TED |
2020 |
Dominant |
First FDA-approved drug for TED |
| Off-label steroids |
TED |
Pre-2020 |
80-90% |
Limited efficacy, side effects |
| Orbital decompression surgery |
TED |
Ongoing |
Variable |
Invasive, reserved for severe cases |
Tepezza holds a near-monopoly in its indication, with minimal direct competition due to lack of approved alternatives.
Pricing Analysis
Current Pricing
- Average Wholesale Price (AWP): Approximately $14,600 per vial.
- Dosing regimen: 8 infusions over 24 weeks.
- Treatment cost per patient: Ranges from $130,000 to $180,000 depending on discounts, insurance coverage, and dosing schedule adjustments.
Cost Components
| Cost Element |
Approximate Cost |
Notes |
| Drug acquisition |
$14,600 per vial |
8 infusions, about 2 vials per infusion |
| Administration |
$2,500 - $4,000 per infusion |
Medical facility charges |
| Ancillary costs |
Variable |
Pre-treatment testing, monitoring |
Total treatment cost: ~$130,000 - $180,000 per patient in the U.S.
Reimbursement Landscape
- Majority insured via commercial insurance, Medicare, or Medicaid.
- Payer negotiations and discounts affect net price.
- Some insurers require prior authorization due to high cost.
Market Projections
Short-term (2023-2025)
- Patient uptake: 15,000 - 20,000 patients annually in the U.S.
- Revenue estimate: $2 billion to $3 billion annually based on current pricing and uptake.
Long-term (2026-2030)
- Market penetration: Expected to reach 30-40% of eligible TED patients.
- Potential sales: Up to $4-$6 billion globally, considering expansion into European and Asian markets.
- Patent considerations: No generic competition expected until at least 2030, as patent protections and exclusivity periods extend until 2027-2030.
Pricing Trends
- Market pressure could drive prices downward by 10-20% over next five years.
- Price discounts may increase as new competitors or biosimilar versions enter the market.
- Pricing flexibility will depend on formulary negotiations and reimbursement policies.
Regulatory and Policy Factors
- FDA's Orphan Drug designation: Extended market exclusivity.
- Potential for biosimilars after patent expiry.
- Reimbursement policies highly influence net revenues.
Risks and Opportunities
Risks:
- Emergence of competitors or biosimilars.
- Payer resistance impacting reimbursement.
- Off-label alternative therapies gaining acceptance.
Opportunities:
- Expansion into new indications like other autoimmune orbital diseases.
- International expansion.
- Combination therapies with other immunomodulators.
Key Takeaways
- NDC 51407-0042 (Teprotumumab-trbw) dominates a niche market with high unmet need.
- U.S. treatment costs average $130,000-$180,000 per patient annually.
- The market is expected to generate over $2 billion annually in the short term, with growth driven by increased awareness, diagnosis, and approved indications.
- Price reductions are likely as insurers negotiate discounts; however, the overall revenue trajectory remains strong due to limited competition.
FAQs
Q1: When will biosimilars for Teprotumumab likely enter the market?
A1: Biosimilar entry is possible post-2030, depending on patent expiry and regulatory approval processes.
Q2: What factors could impact Teprotumumab pricing?
A2: Introduction of competitors, bargaining power of payers, and manufacturing costs.
Q3: How does the current treatment cost compare with alternative therapies?
A3: Traditional therapies, such as steroids, are substantially cheaper but less effective; surgical options are costly and invasive.
Q4: What is the reimbursement outlook for Tepezza?
A4: Favorable, given FDA approval and orphan drug status; however, reimbursement levels depend on insurer policies.
Q5: Are there any upcoming regulatory changes affecting this drug?
A5: No significant recent regulatory changes currently announced; ongoing post-marketing studies may influence future policies.
References
- Smith, T., et al. (2017). Epidemiology of thyroid eye disease. Journal of Endocrinology, 235(3), 189-196.
- U.S. Food and Drug Administration. (2020). FDA approves Tepezza for thyroid eye disease. [Press release].
- Industry estimates. (2023). Market size and pricing of Tepezza. [Internal report].
[Note: All prices are approximate and may vary based on discounts, insurance negotiations, and geographic factors.]
