Last updated: March 15, 2026
What is the Drug NDC: 64980-0373?
NDC 64980-0373 is a prescription medication manufactured by Gilead Sciences. It is marketed under the brand name Trodelvy (sacituzumab govitecan-hziy), an antibody-drug conjugate used predominantly for metastatic triple-negative breast cancer (mTNBC) and urothelial carcinoma.
Market Landscape
Indications and Approved Uses
| Indication |
Date of FDA Approval |
Patient Population |
Estimated Annual Market Size* |
| Metastatic triple-negative breast cancer (mTNBC) |
April 2021 |
15,000-20,000 U.S. patients |
15,000-20,000 patients annually* |
| Urothelial carcinoma |
December 2021 |
13,000-15,000 U.S. patients |
13,000-15,000 patients annually* |
*Market size estimates are based on US incidence/prevalence data; global opportunities could expand by 1.5x to 2x.
Competitive Landscape
Key competitors:
- Eribulin (Halaven): Used in metastatic breast cancer. Market size approximately 9,000 patients annually in the U.S.
- Sacituzumab govitecan (Trodelvy nominally): The same drug, indicating the market is limited to this brand.
- Enfortumab Vedotin: For urothelial carcinoma, with a market estimated at 13,000-15,000 patients in the U.S.
- Other chemotherapies: Used as alternative treatments, including platinum-based regimens.
Market Dynamics
- Pricing sensitivity: Patients and payers have shown resistance to high-cost treatments without clear overall survival benefits.
- Reimbursement landscape: Medicare and private insurers cover Trodelvy, with negotiated pricing and utilization management.
- Uptake rates: Early adoption has been strong in academic centers, with slower penetration into community settings.
Price Projections
Current Wholesale Acquisition Cost (WAC)
- As of Q1 2023, WAC for Trodelvy is approximately $12,750 per 20 mg vial.
- Typical dose: 10 mg/kg IV on Days 1 and 8 of each 21-day cycle.
Estimated Cost per Treatment Course
| Treatment Details |
Calculation |
Approximate Cost |
| Patient weight: 70 kg |
Dose per cycle: 700 mg (10 mg/kg x 70 kg), requiring 1–2 vials |
$25,500–$51,000 |
| Treatment cycles: 6-8 |
Total cost: $153,000–$408,000 (excluding administration) |
[1] |
Price Trends and Projections
- Short-term outlook (next 1-2 years): Price stability with potential slight decrease (5-10%) driven by payer negotiations and market competition.
- Medium-term (3-5 years): Potential for price adjustment downward due to biosimilar or alternative therapies entering the market, though no biosimilars are currently approved.
- Long-term: Introduction of combinatorial regimens or new indications could influence pricing; prices may stabilize around $12,000–$15,000 per treatment cycle.
Readiness for Biosimilar Entry
- No biosimilar competitors exist yet for sacituzumab govitecan.
- Patent protections are active until 2030, with data exclusivity until then.
- Biosimilar development is currently in early stages, with no filings submitted as of 2023.
Revenue and Market Penetration Estimates
| Year |
Estimated Patients |
Market Penetration |
Revenue (USD billions) |
Assumptions |
| 2023 |
15,000 |
50% of indicated |
0.19 |
WAC at ~$13,000 per cycle, 85% utilization; 6 cycles on average |
| 2024 |
17,000 |
60% of indicated |
0.30 |
Slight increase in adoption, stable pricing |
| 2025 |
20,000 |
70% of indicated |
0.35 |
Market maturation, stable pricing, expansion into new regions |
Regulatory and Patent Landscape
| Aspect |
Details |
| Patent expiry |
2030 (anticipated patent expiration) |
| Data exclusivity |
12 years from approval in the US (April 2021) |
| Pending biosimilar applications |
None as of 2023; biosimilar development in early stages globally |
| Upcoming regulatory reviews (if any) |
No major reapplications planned before 2025 |
Key Takeaways
- Market Opportunity: US annual market for sacituzumab govitecan ranges 15,000–20,000 patients, with current WAC priced at approximately $13,000 per cycle.
- Revenue Potential: Peak sales estimated at $350–$400 million annually in the US by 2025, contingent on market penetration and reimbursement policies.
- Competitive Risks: Patent expiration in 2030, potential biosimilar entry, and competitive therapies could impact pricing.
- Pricing Trajectory: Short-term stability, with potential slight decreases over medium to long-term periods due to market dynamics.
5 FAQs
1. What factors influence the pricing of sacituzumab govitecan?
Pricing is driven by clinical efficacy, treatment protocols, payer negotiations, manufacturing costs, and market competition.
2. When could biosimilars affect sacituzumab govitecan’s market share?
Biosimilars are unlikely before 2030 due to patent protections and regulatory requirements, though early development may influence market expectations sooner.
3. How does the cost of Trodelvy compare to alternative treatments?
Trodelvy's treatment cost is higher than traditional chemotherapies but justified by its targeted mechanism and demonstrated efficacy in hard-to-treat cancers.
4. What geographic markets have growth potential beyond the US?
Europe and Asia Pacific present significant opportunities, with local approval timelines potentially delaying market entry.
5. Are new indications expected to change the market size?
Yes, approval of Trodelvy for additional cancer types could expand the patient population and revenue opportunities.
References
- U.S. Food and Drug Administration. (2021). Trodelvy (sacituzumab govitecan-hziy) approval announcement.
- IQVIA. (2023). U.S. Prescription Market Data.
- Gilead Sciences. (2023). Trodelvy Prescribing Information.
