Last updated: March 13, 2026
What is the Drug with NDC 50742-0246?
The drug identified by NDC 50742-0246 is Sage Therapeutics' ZULRESSO (brexanolone) injection. Approved by the FDA in June 2019, ZULRESSO treats postpartum depression (PPD) in adult women. It is administered as a 60-hour intravenous infusion in a healthcare setting. The drug is distinguished by its novel mechanism targeting GABA_A receptor modulation, setting it apart from traditional antidepressants.
Market Size and Growth Drivers
Incidence of Postpartum Depression
- US postpartum depression affects approximately 10-15% of women within the first year postpartum.
- Estimated annual U.S. cases: 600,000 to 900,000 women.
- Potential patient pool for ZULRESSO: 40,000 to 100,000 women annually, assuming diagnosis and treatment access.
Market Penetration of ZULRESSO
- As of 2022, initial uptake has been modest, with estimated prescribing volumes around 1,000 courses annually.
- Factors limiting adoption include high cost, logistical challenges of infusion therapy, and cost reimbursement limitations.
Competitive Landscape
| Competitors |
Status |
Market share (Est.) |
Notes |
| ZULRESSO |
First-in-class for PPD |
Low (approx. 4%) |
No direct pharmacological competitors, but traditional oral antidepressants remain common. |
| Traditional antidepressants |
SSRI/SNRI/DAMs |
Dominates over 90% of treatment |
Widely prescribed, lower cost. |
Key Market Trends
- Rising awareness of PPD and increasing diagnosis drive potential growth.
- New formulations or administration methods (e.g., nasal) may expand market.
- Healthcare reimbursement policies influence accessibility.
Price Benchmarks and Revenue Projections
Current Pricing
- List price per 60-hour infusion course: approximately $35,000.
- Estimated net price (after discounts and insurance adjustments): $25,000 to $30,000.
Revenue Estimates
| Year |
Prescriptions |
Revenue (millions USD) |
Assumptions |
| 2022 |
1,200 courses |
~$30 million |
Based on $25,000 average net price, modest market share growth. |
| 2023 |
2,400 courses |
~$60 million |
Doubling sales due to increasing awareness and coverage expansion. |
| 2024+ |
4,800+ courses |
$120+ million |
Continued growth driven by pipeline acceptance and expanded clinician familiarity. |
Price Trajectory
- Short-term prices remain high due to the specialized administration process.
- Long-term price decreases expected with:
- Entry of biosimilars or generic alternatives.
- Development of less invasive delivery methods.
- Competitive pressures and insurance negotiations.
Future Market Outlook and Risks
Growth Potential
- The postpartum depression market is projected to expand by a compound annual growth rate (CAGR) of 15% over the next five years.
- Broader recognition of PPD benefits from increased advocacy and screening could accelerate market penetration.
- Equity-based payers increasingly cover ZULRESSO, improving access.
Risks
- Pricing pressures due to expensive infusions and cost containment policies.
- Competition from oral therapies in development.
- Limited patient population due to social, economic, or diagnostic barriers.
- Regulatory actions or reimbursement policies that restrict utilization.
Price Competition and Cost-Containment Strategies
- Payers may negotiate discounts, further reducing net prices.
- Value-based contracting could lower overall expenditure.
- Manufacturers expanding indications or developing alternative formulations could influence pricing and market share.
Summary
ZULRESSO (brexanolone) injection holds a niche position within the postpartum depression treatment landscape. Although the initial market size is limited, growth hinges on increasing diagnosis, reimbursement access, and potential formulations change. The current price remains high relative to typical antidepressant courses, but projected revenue growth reflects a gradual market expansion.
Key Takeaways
- NDC 50742-0246 (ZULRESSO) is a first-in-class PPD treatment introduced in 2019.
- The drug's market size is constrained by limited diagnosis and infusion logistics, but growing awareness supports future expansion.
- Pricing remains high at approximately $25,000–$30,000 per course.
- Revenue projections suggest potential growth to over $120 million annually within a few years.
- Major risks include reimbursement policies, competition, and operational barriers to infusion-based treatments.
FAQs
1. What factors are most influential in the price setting for ZULRESSO?
Reimbursement negotiations, the intravenous administration process, and the lack of generic equivalents influence the high pricing of ZULRESSO.
2. How does the market for postpartum depression treatments evolve?
The market is expected to grow due to increased diagnosis, awareness, and acceptance of innovative therapies, despite constraints imposed by administration complexity.
3. Are there alternative delivery methods in development?
Yes, phase 3 development of nasal formulations aims to simplify administration and potentially reduce costs.
4. What is the outlook for competition impacting ZULRESSO’s market share?
Oral antidepressants and emerging therapies present competition but currently lack the rapid onset and specific indication for PPD that ZULRESSO offers.
5. How do reimbursement policies affect the drug’s market?
Coverage improvements and value-based arrangements can enhance patient access, positively influencing sales.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves first treatment for postpartum depression.
[2] IQVIA. (2022). Market data and healthcare utilization reports.
[3] Sage Therapeutics. (2022). Investor presentation on ZULRESSO and pipeline.
[4] CDC. (2022). Postpartum depression statistics and trends.
[5] FiercePharma. (2022). Pricing and reimbursement updates for specialty drugs.
