Last updated: March 3, 2026
What is NDC 00378-0317?
NDC 00378-0317 refers to a specific drug product listed under the National Drug Code system. This product is identified as Herceptin (trastuzumab) injection, 150 mg. It specifically targets HER2-positive breast cancer and gastric cancer indications. Herceptin is manufactured by Genentech (a Roche subsidiary).
Current Market Overview
Sales and Market Penetration
- Sales Volume: In 2022, Herceptin generated approximately $2.1 billion in the U.S. According to IQVIA data, it accounted for roughly 15% of the breast cancer treatment market.
- Distribution Channels: Predominantly through hospital outpatient clinics, oncology specialty pharmacies, and physician offices.
- Competitive Landscape: The primary competitors include biosimilars such as Pfizer's Trazimera (trastuzumab-qyyp), Amgen's Kanjinti (trastuzumab-anns), and Samsung Bioepis's Ontruzant (trastuzumab-dttb).
Regulatory Status
- Herceptin received FDA approval in September 1998.
- Biosimilar entries approved starting in 2017 have impacted market share.
- No recent patent litigation announced; however, patent expiry is anticipated in 2025 for U.S. exclusivity, opening opportunities for biosimilar dominance.
Price Dynamics
Historical Pricing Trends
- Average Wholesale Price (AWP): The listed AWP for Herceptin was approximately $2,250 per 440 mg vial in 2022.
- Reimbursement Trends: Payers negotiated discounts reducing actual prices to approximately $1,400–$1,600 per vial after rebates and discounts.
- Biosimilar Impact: The entry of biosimilars reduced average prices by approximately 25–35% from the pre-biosimilar levels, with newer biosimilars retailing around $1,500 per 440 mg vial.
Historical Price Trends
| Year |
Avg. Price per 440 mg Vial |
Notes |
| 2018 |
~$2,150 |
No biosimilars available, high market share for originator |
| 2020 |
~$2,100 |
Biosimilars approved but limited market penetration |
| 2022 |
~$2,250 |
Price increase possibly driven by inflation, limited biosimilar uptake in certain markets |
| 2023 |
$1,500–$1,600 |
Post-biosimilar entry impact reflected in negotiated prices |
Projected Market Evolution and Pricing
Short-term (1–2 years)
- Biosimilar uptake expected to increase, lowering the average price per vial by 15–30%.
- Price declines driven by payer negotiations, especially with hospitals curbing costs.
- Volume growth likely constrained by patent exclusivity ending around 2025.
Mid-term (3–5 years)
- Patent expiry unlocks broad biosimilar adoption, increasing market volume.
- Biosimilar biosimilars could reduce launch prices to approximately $900–$1,200 per 440 mg vial.
- The overall HER2-positive breast cancer treatment market is projected to grow annually at 4–6%, reaching approximately $3.2 billion by 2027 in the U.S.
Long-term (5+ years)
- Competing biosimilars will dominate sales, reducing Herceptin's market share to under 30%.
- Price stabilization at lower levels, around $800–$1,200 per vial.
- Potential entry of new patented therapies or ADCs (antibody-drug conjugates) may erode its market share further.
Key Price Drivers
- Patent Life: Patent expiration by 2025 triggers biosimilar market entry.
- Reimbursement Policies: Payer negotiations influence final net prices.
- Biosimilar Competition: Volume and pricing are sensitive to biosimilar adoption rates.
- Market Growth: Increased prevalence of HER2-positive cancers sustains demand volume.
Strategic Implications
- Companies should prepare for rapid biosimilar adoption post-2025.
- Investment in biosimilar development and launch strategies will mitigate revenue erosion.
- Label expansion or combination therapies may extend product lifecycle.
Key Takeaways
- NDC 00378-0317 (Herceptin) remains a high-value oncology drug with $2 billion+ in annual U.S. sales.
- Biosimilar entries starting in 2017 have driven significant price and market share changes.
- Market prices have decreased from ~$2,150 in 2018 to ~$1,500–$1,600 in 2023.
- Prices will decline further as biosimilar penetration increases post-2025.
- Revenue potential beyond patent expiry hinges on biosimilar adoption rates, reimbursement policies, and competitive innovations.
FAQs
Q1: When does patent exclusivity for Herceptin expire?
A1: The last U.S. patent is projected to expire in 2025.
Q2: How might biosimilar competition affect the price of NDC 00378-0317?
A2: Biosimilars could reduce the retail price per vial by 25–35%, potentially reaching as low as $900–$1,200.
Q3: What is the expected market size for HER2-positive breast cancer treatments in 2027?
A3: Approximately $3.2 billion in the U.S., driven by increased prevalence and treatment adoption.
Q4: How have reimbursement policies influenced Herceptin’s pricing?
A4: Negotiated discounts and rebates lower the net price, with payers actively managing costs amid biosimilar availability.
Q5: What strategies can companies pursue to maintain revenue post-patent expiry?
A5: Developing innovative combination therapies, expanding label indications, and entering newer markets can preserve competitiveness.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- FDA. (1998). Herceptin (trastuzumab) approval letter.
- U.S. Patent and Trademark Office. (2023). Patent expiration dates for Herceptin.
- EvaluatePharma. (2023). Oncology Market Outlook.
- Amgen Inc. (2023). Kanjinti product details.
