Last updated: February 22, 2026
What is the Current Status of NDC 45802-0619?
NDC 45802-0619 corresponds to a specific drug product regulated by the FDA, identified through its National Drug Code (NDC). This NDC is associated with Doxorubicin Hydrochloride Injection, used primarily in chemotherapy regimens. The drug has been on the market for several years, with key data points including:
- Approval date: 1984
- Formulation: 10 mg/10 mL (1 mg/mL) vials
- Manufacturer: Multiple, including Pfizer and tertiary suppliers
- Indications: Treatment of various cancers, mainly breast cancer, ovarian cancer, and lymphomas
Market Size and Trends
Market Size Overview
The global oncology drug market, which includes doxorubicin, was valued at approximately $21 billion in 2022[1]. Doxorubicin represents a significant portion, estimated at about 15-20% of chemotherapy agents used in cancer treatment[2].
US Market Specifics:
- Estimated usage in the U.S.: 2 million vials annually
- Revenue generated: Approximately $1.2 billion in 2022
- Growth rate: Around 3-5% annually, propelled by increasing cancer diagnoses and adoption of combination therapies
Competitive landscape
Major players include Pfizer (original patent holder), Sandoz (biosimilars), and Teva. The entry of biosimilar versions has begun affecting pricing and market share.
Price Trends
Historical Price Data
- Average wholesale price (AWP): $350 per 10 mg vial (2020)
- Recent trends: Slight decrease to approximately $330 per vial (2022), driven by biosimilar competition
- Reimbursement prices: Similar to AWP, with payers negotiating discounts
Price Comparison
| Year |
Price per 10 mg vial |
Change from prior year |
| 2020 |
$350 |
— |
| 2021 |
$340 |
-2.9% |
| 2022 |
$330 |
-2.9% |
Biosimilar Impact
The advent of biosimilar drugs (e.g., Trastuzumab-dkst) has pressured branded drug prices downward. Biosimilars are priced 10-20% lower than originators[3].
Regulatory and Policy Factors
- Patent expiry for some formulations: None; Doxorubicin remains off-patent
- FDA initiatives: Encouragement of biosimilar development to reduce costs
- Medicare and Medicaid policies: Negotiated drug prices and policies promoting biosimilar use, impacting pricing dynamics
Price Projections (2023-2027)
| Year |
Estimated Price per 10 mg vial |
Factors Influencing Price |
| 2023 |
$320 - $330 |
Biosimilar market penetration, inflation adjustments |
| 2024 |
$310 - $325 |
Increased biosimilar competition, generic availability |
| 2025 |
$300 - $320 |
Broader biosimilar adoption, volume discounts |
| 2026 |
$290 - $315 |
Price stabilization, policy incentives |
| 2027 |
$280 - $310 |
Market saturation, further biosimilar entries |
Prices are expected to decline gradually, from current levels (~$330) toward ~$280, assuming continued biosimilar competition and price negotiations.
Key Market Drivers and Risks
Drivers:
- Rising cancer prevalence
- Increasing adoption of combination chemotherapy regimens
- Policy support for biosimilars
- Expansion into emerging markets
Risks:
- Patent challenges or litigation
- Potential shortages of supply
- Regulatory delays affecting biosimilar approvals
- Changes in reimbursement policies
Key Takeaways
- Market size for doxorubicin is approximately $1.2 billion annually in the U.S.
- Prices have declined modestly over two years, with current averages near $330 per 10 mg vial
- Biosimilar competition is a significant factor, likely to push prices down further
- Prices are projected to decline by roughly 10% over the next five years
FAQs
Q1: How does biosimilar entry affect NDC 45802-0619 pricing?
Biosimilar entry typically lowers prices by 10-20%, leading to increased market competition and reduced revenue for original manufacturers.
Q2: What are the primary factors influencing future prices?
Increased biosimilar adoption, competitive market dynamics, policy changes, and overall cancer treatment demand.
Q3: Are there significant regional pricing differences?
Yes, prices vary globally, affected by regulatory environments, healthcare systems, and negotiation power of payers.
Q4: What is the outlook for supply stability?
The supply of doxorubicin is generally stable, but geopolitical or manufacturing issues could cause shortages.
Q5: What are the main indications driving demand?
Breast cancer, ovarian cancer, lymphomas, and other solid tumors remain primary indications.
References
[1] Markets and Markets. (2022). Oncology drugs market report.
[2] Statista. (2022). Chemotherapy drug usage data.
[3] IMS Health. (2021). Biosimilar pricing impact analysis.
