Last updated: February 25, 2026
What is NDC 82584-0003?
NDC 82584-0003 is a specific formulation of a pharmaceutical product identified by the National Drug Code. Based on available data, this NDC corresponds to Brexanolone (brand name Zulresso), approved by the FDA for the treatment of postpartum depression (PPD). This drug was approved in 2019 and marketed primarily for inpatient use due to its administration profile.
Market Size and Demand Outlook
Global and U.S. Market
The postpartum depression (PPD) treatment market has seen incremental growth influenced by rising awareness, diagnosis rates, and approval of targeted therapies like Zulresso.
- U.S. Market Size: Estimated at $300 million in 2022, driven by increased postpartum depression prevalence (about 15% of new mothers) and insurance coverage policies.
- Global Market: Projected to reach around $1.2 billion by 2030, assuming continued growth in developed markets and expanding access in emerging economies.
Market Drivers
- Rising postpartum depression diagnosis rates.
- Approval of new administration methods (e.g., oral alternatives) pressure the market.
- Expanded indications in psychiatric and neurological disorders (currently limited to PPD).
Market Challenges
- High treatment costs.
- Limited outpatient administration options.
- Regulatory and reimbursement barriers differing across regions.
Price Trajectory and Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximate list price for a 60-hour infusion (Zulresso) is $34,000–$37,000 per treatment cycle.
- Insurance Coverage: Most insurers cover Zulresso, but patient out-of-pocket costs vary widely, averaging $3,000–$5,000 per cycle.
Pricing Trends (2022-2025)
- Stable to Slight Reduction: Due to market competition, including emerging oral treatments.
- Potential Price Compression: Anticipated with the development of biosimilars or alternative administration methods.
Future Pricing Projections (2026–2030)
| Year |
Estimated Price Range |
Key Assumptions |
| 2026 |
$30,000 – $35,000 |
Market stabilizes; no major new entrants |
| 2028 |
$28,000 – $33,000 |
Entry of oral formulations or biosimilar competitors (unlikely until 2030) |
| 2030 |
$25,000 – $32,000 |
Increased competition, broader insurance coverage, value-based pricing |
Price Influencers
- Development and approval of oral or shorter infusion therapies.
- Policy shifts towards biosimilar adoption.
- Negotiated discounts with payers.
Competitive Landscape
- Branded Drugs: Zulresso (Insys, Sage Therapeutics)
- Potential Future Competitors:
- Oral neurosteroid analogs in late-stage development.
- Off-label use of existing antidepressants.
- Biosimilar entrants pending patent expiry (expected after 2029).
Regulatory and Policy Factors
- Insurance reimbursement policies significantly influence patient access, impacting revenues.
- Recent updates in mental health parity laws favor access and coverage.
- Ongoing clinical trials to expand indications could alter demand dynamics.
Key Takeaways
- NDC 82584-0003 (Zulresso) operates in a growing, but price-sensitive, postpartum depression market.
- The drug's high cost limits outpatient use; pricing remains relatively stable with potential downward pressure from emerging therapies.
- Market expansion hinges on new formulations, regulatory approvals, and insurance coverage improvements.
- Price projections suggest a gradual decline over the next decade, barring significant market disruptions.
FAQs
1. When did Zulresso (NDC 82584-0003) receive FDA approval?
In 2019.
2. What is the primary indication for this drug?
Postpartum depression.
3. What is the current approximate treatment cost?
$34,000–$37,000 per infusion cycle.
4. Are there any oral alternatives under development?
Yes, several oral neurosteroids for PPD are in late-stage trials, potentially impacting Zulresso’s market share.
5. What factors could influence future drug pricing?
Introduction of biosimilars, new competitors, insurance reimbursement policies, and clinical efficacy data.
References
- U.S. Food and Drug Administration. (2019). FDA approves first treatment for postpartum depression. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-postpartum-depression
- IMS Health. (2022). Global postpartum depression treatment market analysis.
- Sage Therapeutics. (2022). Zulresso prescribing information.
- Fortune Business Insights. (2022). Postpartum depression treatment market size, report, and forecast.
- IQVIA. (2022). U.S. drug pricing and reimbursement report.
