Last updated: February 23, 2026
What is the Drug Associated with NDC 57237-0119?
NDC 57237-0119 corresponds to Samidorphan in combination with Buprenorphine. It is marketed under the brand name ALKS-5461 by Alkermes. ALKS-5461 is developed as an adjunctive treatment for major depressive disorder (MDD), specifically targeting treatment-resistant depression.
Market Context
Therapeutic Area
- Major Depressive Disorder (MDD) with treatment resistance
- Current treatments include selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and atypical antidepressants.
Competitive Landscape
- Other drugs have approvals or in development for treatment-resistant depression (TRD), including:
- Esketamine (Spravato) by Johnson & Johnson
- Brexanolone (Zulresso) by Sage Therapeutics
- Vortioxetine and other off-label options
Market Size
- Global MDD market size was valued at approximately $13 billion in 2022 and grows annually at roughly 2-3%. Treatment-resistant segment accounts for an estimated 20-25% of MDD cases.
- Estimated TRD market size: $2.5-$3.25 billion in 2022, with a forecast CAGR of 8% over the next five years.
Regulatory Status
- ALKS-5461 has not received FDA approval as of 2023; phase III trials encountered delays due to safety and efficacy concerns reported in earlier studies.
Market Entry and Adoption Challenges
- Regulatory uncertainties inhibit commercialization
- Existing approved therapies have established prescriber bases
- Perceptions of safety, particularly in opioid-related areas, pose hurdles
- Pricing negotiations with payers central to market penetration
Price Projections
Cost Benchmarks
- Spravato (Esketamine): Marketed price varies
- List price: approximately $590 per dose, administered twice weekly initially
- Annual treatment costs often range between $20,000 - $30,000
- Reimbursement landscape
- Payers typically negotiate discounts leading to net prices 20-50% lower than list prices
Expected Pricing for ALKS-5461
- Early estimates suggest a price point around $15,000 - $25,000 annually for treatment
- Due to regulatory uncertainty, pricing may be conservative, with a premium over existing oral antidepressants but below esketamine
Revenue Estimates
- Market penetration assumptions
- 5-10% of TRD patients in first 3 years
- Annual sales volume: approximately 100,000-200,000 prescriptions
- Projected revenues (2024-2028):
- Year 1: $50 million to $150 million
- Year 3: $300 million to $600 million
- Year 5: up to $1 billion if regulatory approval and market acceptance occur
Pricing Sensitivity
- Price elasticity is moderate; high costs could limit adoption
- Cost-effectiveness analyses favor drugs with improved efficacy or safety profiles
- Negotiations with insurers will influence real-world prices significantly
Risks and Opportunities
Risks
- Failure to achieve approval
- Competition from established therapies
- Safety concerns impacting reimbursement
Opportunities
- If approved, rapid adoption among psychiatrists seeking new options
- Potential for federal and private payers to negotiate favorable pricing owing to high unmet need
- Expansion into other indications, including bipolar disorder or opioid use disorder, presents additional revenue streams
Key Takeaways
- The approval pathway and market acceptance of ALKS-5461 remain uncertain as of 2023.
- Market size for TRD treatments estimated at $2.5-$3.25 billion globally.
- Price projections hover around $15,000–$25,000 annually, with revenues potentially reaching $1 billion within five years of launch.
- Competitive landscape remains dominated by esketamine, which constrains pricing power.
- Success hinges on regulatory approval, safety profile, and payer negotiations.
FAQs
1. When could ALKS-5461 realistically enter the market?
Pending successful phase III trial completion and regulatory approval, likely within two to three years (2024-2026).
2. How does the price compare to existing therapies?
It would be priced higher than oral antidepressants but lower than intranasal esketamine, targeting a niche with fewer options.
3. What factors could accelerate revenue growth?
Favorable regulatory outcomes, high unmet clinical needs, and broad payer acceptance.
4. What are the main barriers to market success?
Regulatory hurdles, safety concerns, market competition, and payer negotiation complexities.
5. How does the safety profile impact pricing?
Safety concerns could depress prices; a strong safety profile can enable premium pricing.
Sources
[1] Mordock, J. (2022). Major depressive disorder market analysis. Pharmaceutical Business Review.
[2] IQVIA. (2022). Global Prescription Drug Markets.
[3] FDA. (2023). Regulatory updates on ALKS-5461.
[4] IQVIA. (2022). Treatment-resistant depression market analysis.
[5] Lazare, S. (2023). Competitive landscape of depression treatments. Journals of Pharmacoeconomics.
