Last updated: February 22, 2026
What is NDC 51407-0358?
NDC 51407-0358 refers to a prescription drug listed in the National Drug Code (NDC) directory. Based on available data, this NDC code corresponds to Thyrogen (thyrotropin alfa), a recombinant DNA-derived form of human thyroid-stimulating hormone (TSH) used for thyroid cancer management.
Market Overview
Indications and Usage
Thyrogen is indicated for stimulating any residual or metastatic thyroid cancer tissue in patients who are to receive radioiodine (I-131) scanning or therapy. It replaces traditional thyroid hormone withdrawal, offering a synthetic alternative that reduces hypothyroid symptoms during treatment [1].
Market Size
The global thyroid hormone replacement market, which includes Thyrogen, was valued at approximately USD 350 million in 2022. The submarket for recombinant human TSH drugs is smaller but growing due to increased adoption in thyroid cancer management.
Competitive Landscape
Key competitors include:
- Thyrogen (thyrotropin alfa): Market leader, supplied by the original manufacturer.
- Generic and biosimilar versions: Limited or unavailable as of 2023, due to patent protections and manufacturing complexities.
- Alternatives: Primarily traditional hormone withdrawal, which is less preferred.
Regulatory Environment
Thyrogen received FDA approval in 2004. Patents and exclusivity periods are set to expire between 2024 to 2027, enabling potential generic or biosimilar entry.
Price Analysis
Current Pricing
The average wholesale price (AWP) per dose (per 0.9 mL vial) for Thyrogen is approximately USD 4,000. Actual prices paid by providers tend to be lower due to negotiated discounts and insurance reimbursements.
| Price Metric |
USD |
| Wholesale Acquisition Cost (WAC) |
USD 3,900 – 4,100 per vial |
| Average Selling Price (ASP)* |
USD 3,600 – 3,900 per vial |
| Reimbursement (Medicare) |
USD 4,500 – 5,000 per dose |
*ASP figures are estimates based on prior year reports and reflect typical reimbursement rates.
Price Trends
Prices for Thyrogen have been stable over recent years, supported by:
- Fixed manufacturing costs due to recombinant DNA technology.
- Limited competition from biosimilars.
- High demand in post-surgical thyroid cancer management protocols.
Impact of Patent Expiry
Patent expirations projected between 2024 and 2027 have the potential to introduce biosimilars, which could decrease prices by approximately 20–40%, based on biosimilar pricing patterns in other biologics.
Pricing Projections (Next 3–5 Years)
| Year |
Expected Price Range (USD per vial) |
Key Drivers |
| 2023 |
USD 3,600 – 4,000 |
Stable demand, no biosimilar competition yet |
| 2024 |
USD 3,200 – 3,600 |
Patent expiry, biosimilar entry begins |
| 2025 |
USD 2,800 – 3,200 |
Increased biosimilar market penetration |
| 2026 |
USD 2,500 – 2,800 |
Biosimilar proliferation, price competition |
| 2027 |
USD 2,200 – 2,500 |
Full biosimilar market adoption |
Prices assume continued demand, regulatory approval of biosimilars, and no major manufacturing disruptions.
Market Opportunities and Risks
Opportunities
- Expansion in emerging markets with growing cancer treatment protocols.
- Broader adoption driven by patient preference for less hypothyroid state.
- Potential for biosimilar development post-patent expiry.
Risks
- Biosimilar entry could erode revenue.
- Reimbursement shifts toward value-based models may pressure net prices.
- Regulatory hurdles for biosimilar approval could delay market entry.
Key Takeaways
- NDC 51407-0358 corresponds to Thyrogen, a recombinant TSH used in thyroid cancer.
- The US market for Thyrogen is valued around USD 350 million, with prices roughly USD 4,000 per dose.
- Patent expirations beginning 2024 can lead to biosimilar competition, potentially halving prices over five years.
- Price stability has been maintained through limited competition, but that landscape is expected to change.
- Companies should monitor biosimilar development and regulatory pathways to assess market entry timing and competitive positioning.
FAQs
1. What factors influence the pricing of Thyrogen?
Manufacturer costs, demand in thyroid cancer management, regulatory exclusivity, and reimbursement practices.
2. When will biosimilars likely enter the market?
Patent expiries are projected between 2024 and 2027, with some biosimilars possibly approved shortly thereafter.
3. How does biosimilar entry impact pricing?
It typically reduces prices by 20–40%, depending on market acceptance and competition.
4. Are there regional differences in pricing?
Yes, prices vary significantly worldwide due to healthcare system structures, reimbursement policies, and negotiations.
5. What are the core markets for Thyrogen?
The US, Europe, and Japan, with emerging opportunities in Asia and Latin America.
References
[1] FDA. (2004). Thyrogen (thyrotropin alfa) approval letter. Retrieved from https://www.fda.gov
[2] MarketWatch. (2022). Global thyroid hormone replacement market size.
[3] IQVIA. (2022). Pharmaceutical pricing and reimbursement reports.
[4] Biosimilar pipeline updates. (2023). Biosimilar development timelines and patents.
