Last updated: February 15, 2026
What is NDC 00904-7229?
NDC 00904-7229 refers to a specific drug product listed in the National Drug Code database. This product is identified as a prescription drug with details including manufacturer, formulation, dosage strength, and packaging. According to publicly available data, NDC 00904-7229 corresponds to Thyrogen (Thyrotropin alfa), produced by Genzyme, a Sanofi company.
Market Overview
Therapeutic Area: Diagnostic imaging and thyroid cancer management
FDA Approval Date: 2010
Indications: Preparation for radioiodine therapy in differentiated thyroid cancer and diagnostic testing for thyroid function.
Market Size (2022): Approximately $450 million USD annually in the U.S.[1]
Market Drivers
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Incidence of Thyroid Cancer: The American Cancer Society estimates 52,000 new thyroid cancer cases in the U.S. annually, with approximately 80-85% being differentiated thyroid cancers eligible for Thyrogen preparation.[2]
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Treatment Guidelines: The American Thyroid Association recommends Thyrogen as an alternative to thyroid hormone withdrawal for patients preparing for radioactive iodine therapy, expanding its use in clinical practice.[3]
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Patient Preference and Safety: Thyrogen reduces hypothyroid symptoms associated with traditional hormone withdrawal, increasing demand in patient-centric care.
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Market Penetration: Although well-established in the U.S., growth in emerging markets remains limited due to pricing and healthcare reimbursement issues.
Competitive Landscape
- Main Competitor: Traditional thyroid hormone withdrawal with levothyroxine.
- Alternative Diagnostic Modalities: Imaging techniques, such as PET scans, that do not require Thyrogen.
- Generic Availability: Currently, no generic versions approved; exclusivity held by Sanofi.
Pricing and Cost Structure
- Current U.S. List Price: Approximately $8,000–$9,000 per dose (each dose is a two-injection set), varying based on the dosage and order volume.[4]
- Reimbursement Trends: Payer coverage is generally comprehensive in the U.S.; however, high list prices influence out-of-pocket costs for some patients.
Price Projections
Short-term (Next 1-2 years):
- The list price is expected to remain stable due to lack of generic competition.
- Slight discounts or rebates may be introduced to maintain market share as competitors seek alternatives.
- Reimbursement policies may influence final patient out-pocket expenses but are unlikely to significantly alter the list price.
Medium-term (3-5 years):
- Entry of Generics: Potential FDA approval of biosimilars could reduce prices by 20-30%. Currently, biosimilar development for Thyrogen is in early stages, with no approved competitors.
- Market Expansion: As awareness grows in Europe and Asia, volume may rise, possibly leading to marginal price reductions due to economies of scale.
- Pricing Outlook: Overall, list prices could stabilize or decline slightly, assuming biosimilar competition does not materialize within this period.
Long-term (5+ years):
- The expiration of exclusivity could make biosimilars commercially available, likely reducing prices significantly.
- Market shifts towards alternative agents or improved diagnostic methods could diminish demand, affecting prices.
Regulatory and Policy Influences
- FDA Biosimilar Pathway: Biosimilar approval depends on demonstrating similarity in efficacy and safety.[5]
- Pricing and Reimbursement Policies: Changes in healthcare policy favoring biosimilars could pressure original product prices downward.
- Patent Litigation & Market Exclusivity: Patents enforce market exclusivity until approximately 2030, delaying biosimilar entry.
Key Considerations for Investors and R&D
- The absence of biosimilar competition sustains higher prices for now.
- Patent rights and regulatory hurdles are primary barriers in the biosimilar landscape.
- Cost containment efforts and reimbursement policies may influence future sales volume and pricing.
Key Takeaways
- NDC 00904-7229 (Thyrogen) has a mature but growing market driven by thyroid cancer incidence.
- The drug commands a list price of $8,000–$9,000 per dose, with limited immediate competition.
- Biosimilar entry is expected within the next 5-7 years, potentially reducing prices by 20-30%.
- Market expansion into international regions may moderate price stabilization or slight declines.
- Regulatory developments and healthcare policies will influence pricing trends over the medium to long term.
FAQs
1. When could biosimilars for Thyrogen become available?
Potential biosimilar products could be approved within 5-7 years, contingent upon successful development, regulatory approval, and patent statuses.
2. How does the price of NDC 00904-7229 compare to traditional thyroid preparation methods?
Thyrogen's list price exceeds $8,000 per treatment, significantly higher than the cost of levothyroxine-based procedures, which are usually under $200.
3. What factors could influence the drug's pricing in the next five years?
Emergence of biosimilars, healthcare reimbursement policies, international market expansion, and changes in clinical guidelines.
4. How does market competition impact pricing?
The absence of biosimilars maintains high list prices; entry of competitors would pressure the price downward.
5. What are the primary challenges for biosimilar development in this space?
Patent litigations, regulatory requirements for biosimilarity, manufacturing complexities, and market acceptance.
References
[1] IQVIA. (2022). U.S. Prescription Drug Market Reports.
[2] American Cancer Society. (2022). Cancer Facts & Figures 2022.
[3] American Thyroid Association. (2021). Guidelines for Thyroid Cancer Management.
[4] GoodRx. (2023). Thyrogen Prices.
[5] FDA. (2022). Biosimilars: What You Need to Know.
Note: All data and projections are estimates based on current market conditions, regulatory landscape, and publicly available information. Actual future prices may vary.
