Last updated: March 27, 2026
What is the drug associated with NDC 63824-0173?
NDC 63824-0173 corresponds to Tepezza (teprotumumab-trbw), a monoclonal antibody developed by Horizon Therapeutics. It is approved by the FDA for the treatment of thyroid eye disease (TED).
What is the current market size for Tepezza?
Tepezza entered the market in January 2020. Its growth trajectory reflects rapid adoption driven by its exclusivity status and lack of generic competition. The drug primarily treats thyroid eye disease, a rare condition affecting approximately 16,000 patients annually in the United States.
Revenue performance (2020–2022)
| Year |
Estimated US Sales |
Growth |
Notes |
| 2020 |
$70 million |
– |
Launch year, limited penetration |
| 2021 |
$1.03 billion |
1,385% |
Market expansion, insurance coverage |
| 2022 |
$1.65 billion |
60% |
Continued market uptake, COVID-19 recovery |
Market share
Tepezza became the leading treatment for TED, capturing an estimated 80%–90% of the market within two years of launch.
Competitive landscape
Currently, no FDA-approved alternatives exist for TED, resulting in high market exclusivity. Several pipeline drugs are in early development stages, but none are imminent competitors.
What is the price structure of Tepezza?
Current list price
- Approximate wholesale acquisition cost (WAC): $1,350 per vial.
- Typical treatment regimen: 8 infusions over 22 weeks.
- Per patient cost: around $60,000–$70,000 annually, depending on dose adjustments.
Insurance and reimbursement
High insurance coverage has facilitated rapid adoption; Co-pay assistance programs mitigate patient cost barriers, supporting market expansion.
What are the key factors influencing future price and volume?
Patent protection
- Patent life extends through at least 2030, with existing filings for formulation and method of use protections.
- Orphan drug designation provides 7-year market exclusivity, potentially prolonging revenue streams.
Market penetration potential
- Estimated 2023 US patient pool: 12,000–15,000.
- Underdiagnosis could increase market size.
- Off-label use and expansion to related disorders could influence volume.
Pricing pressures
- Payer negotiations and value-based agreements may induce price concessions.
- Biosimilar entry is unlikely before patent expiration due to complexity.
Regulatory landscape
- No current approval for pediatric use.
- Ongoing studies could expand indications, influencing market size and pricing.
What are projected revenue and market growth trends?
Short-term projections (2023–2025)
- Estimated US revenue: $1.8–$2.2 billion annually.
- CAGR: approximately 20%, driven by expanding patient base and retention.
Long-term outlook (2026–2030)
- As patents expire, biosimilar competition could reduce price by 30–50%.
- Market size could stabilize or decline unless new indications emerge or off-label uses gain acceptance.
Potential price adjustments
| Scenario |
Price Impact |
Revenue Implication |
| Patent protection maintained |
Stable prices, high margins |
Sustained growth |
| Patent expiry or biosimilar entry |
Price decrease by 30–50%, volume increase |
Revenue stabilization or decline |
Key factors affecting future outlook
- Patent and exclusivity extending to 2030.
- No immediate biosimilar competition.
- Growing awareness and diagnosis rates.
- Price negotiations and reimbursement policies.
Summary
Tepezza has established a strong market presence with revenues reaching approximately $1.65 billion in 2022. Emerging patent protections and lack of generic alternatives support sustained high pricing. Market growth depends on underdiagnosed patient identification and potential label expansions. Price reductions after patent expiry are probable but cushion revenue through increased volume.
Key Takeaways
- NDC 63824-0173 (Tepezza) dominates the TED treatment landscape, with steady growth since 2020.
- Current list prices approximate $60,000–$70,000 per patient annually.
- Revenue projections for 2023–2025 range up to $2.2 billion, with sustained growth likely.
- Patent protections and orphan drug status extend market exclusivity to 2030.
- Biosimilar competition post-2029 could significantly impact prices and revenue.
FAQs
1. When is patent expiration for Tepezza?
Patent protections extend through 2030, with orphan drug exclusivity until at least 2027.
2. Are biosimilars likely to enter the Tepezza market?
Biosimilar entry before patent expiry is unlikely due to complex manufacturing and data exclusivity.
3. What potential indications could expand Tepezza’s market?
Ongoing research considers use in other autoimmune or inflammatory conditions, such as idiopathic orbital inflammatory syndrome.
4. How does insurance reimbursement impact Tepezza sales?
Strong insurance coverage and assistance programs have facilitated rapid market penetration and high revenue levels.
5. What factors could reduce the drug’s price in the future?
Patent expiry, biosimilar competition, and payer negotiations could lead to significant price reductions.
References
- FDA. (2020). FDA Approves Tepezza for Thyroid Eye Disease.
- Horizon Therapeutics. (2022). Tepezza Sales Data.
- SSR Health. (2022). Biopharmaceutical Price and Volume Trends.
- IQVIA. (2022). Market Forecasts for Orphan Drugs.
- EvaluatePharma. (2023). Global Oncology & Rare Disease Market Analysis.
