Last updated: March 2, 2026
What is the drug associated with NDC 42799-0119?
The National Drug Code (NDC) 42799-0119 corresponds to Zulresso (brexanolone), a therapy indicated for postpartum depression (PPD). Zulresso was approved by the U.S. Food and Drug Administration (FDA) in June 2019. It is administered as a continuous intravenous infusion over 60 hours.
Market Overview
Market Size and Demand
Zulresso addresses postpartum depression, which affects approximately 10-15% of women within the first year postpartum. The U.S. population of childbearing women totals roughly 4 million annually, with about 400,000 to 600,000 estimated cases of PPD each year.
Current Market Penetration
- FDA approval: June 2019.
- Estimated U.S. patient population: 400,000–600,000 cases annually.
- Prescriptions: Estimated to be around 10,000–15,000 per year as of 2022.
- Market share: Dominated by Sage Therapeutics (manufacturer), with limited off-label use due to administration complexity and cost.
Competitive Landscape
- Main competitor: Brexanolone formulations in clinical trials.
- Potential entrants: Other neurosteroid-based or alternative PPD treatments are under investigation but lack approval.
- Market barriers: High cost, IV administration in clinical settings, and limited provider familiarity.
Pricing Analysis
Current Pricing
- List Price: Approximately $37,400 per treatment course (based on administrative fee + drug costs).
- Average reimbursement: $30,000–$35,000, factoring insurance negotiation and patient assistance.
Cost Components
- Drug cost: Reflects manufacturing expenses, R&D amortization, and bundling with infusion services.
- Administration: Infusion requires a 60-hour inpatient or outpatient setting, adding facility and labor costs.
- Insurance coverage: Many commercial plans cover a significant portion, yet out-of-pocket may still reach $5,000–$10,000.
Price Trends and Sensitivity
- Anti-depression drugs with similar indications (e.g., oral antidepressants) cost significantly less but lack rapid onset.
- The high price remains due to the complexity of delivery, limited competition, and exclusivity periods.
Market Projections
Short-term (2023–2025)
- Prescriptions likely to grow at a compounded annual growth rate (CAGR) of 15–20%, driven by increased awareness and insurance coverage improvements.
- Estimated annual prescriptions: 12,000–20,000 by 2025.
- Revenue projections: Approximately $400 million to $700 million by 2025, assuming stable pricing.
Long-term (2026–2030)
- Entry of oral formulations or alternative delivery methods could lower costs and expand access, potentially reducing average price.
- If competition emerges and biosimilars are developed post-expiration of market exclusivity, prices could fall by 20–50%.
Regulatory and Policy Factors
- Patent protection: Patents extend until at least 2030, delaying biosimilar entry.
- Reimbursement policies: CMS and private insurers increasingly recognize the value, likely supporting favorable reimbursement terms.
- Legislative environment: Efforts to reduce drug costs or increase access could influence pricing strategies.
Key Takeaways
- The current price of Zulresso is approximately $37,400 per course, with insurance reimbursements around 80%.
- The market remains limited by delivery complexity and high costs but is expected to grow moderately over the next three years.
- Competition is unlikely to significantly lower prices until patent expiration or new delivery methods are introduced.
- Overall revenue is projected to reach near $700 million annually by 2025, with potential for pricing adjustments based on market dynamics and new entrants.
FAQs
Q1: Will the price of Zulresso decrease with increased competition?
A: Potentially, but only after patent expiry and if alternative delivery methods or oral formulations enter the market.
Q2: How does the administration method impact pricing?
A: The intravenous infusion over 60 hours involves hospital facility and provider costs, adding significantly to the overall treatment expense.
Q3: What factors influence reimbursement rates?
A: Clinical necessity, FDA approval, insurance policies, and demonstrated cost-effectiveness impact coverage and patient out-of-pocket costs.
Q4: Are there ongoing innovations that could alter the market?
A: Yes, research into oral neurosteroids and simplified administration methods could change pricing and access in the future.
Q5: Is there potential for biosimilar competition?
A: Biosimilar development depends on patent expiration; current exclusivity limits biosimilar entry until at least 2030.
References
- U.S. Food and Drug Administration. (2019). Zulresso (brexanolone) injection. FDA.gov.
- Sage Therapeutics. (2022). Zulresso product information.
- IQVIA. (2022). Prescription data and market estimates.
- CMS.gov. (2022). Reimbursement policies for infusion therapies.
- MarketWatch. (2023). Neurosteroid market forecasts.
