Last updated: February 19, 2026
What is NDC 76282-0334?
NDC 76282-0334 refers to a specific drug product listed in the U.S. National Drug Code (NDC) directory. Based on available data, this NDC is associated with Ulotaront (SEP-363856), an experimental drug developed by Sunovion Pharmaceuticals for schizophrenia and other neuropsychiatric disorders. It remains in clinical development or early commercialization stages.
Market Landscape
Indication and Therapeutic Area
- Ulotaront targets schizophrenia, bipolar disorder, and other psychotic disorders.
- The schizophrenia market in the U.S. reached approximately $16 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3% through 2027 ([1]).
Competitive Landscape
- Main competitors: Risperdal (risperidone), Abilify (aripiprazole), Seroquel (quetiapine), and newer agents like Cambridge's Lumateperone.
- Market entry of Ulotaront could disrupt existing dynamics if approved, particularly due to its novel mechanism of action.
Regulatory Status
- As of December 2022, Ulotaront remains in Phase 3 clinical trials.
- Pending FDA review, approval is expected in late 2023 or early 2024.
Market Potential
- Estimated patient population in the U.S.: approximately 2-3 million diagnosed with schizophrenia.
- If approved, initial penetration rate: 10-15% in the first 3 years.
- Projected revenue in Year 1 post-launch: $200-$500 million, assuming 10-15% market share among new treatments.
Price Projections
Benchmarking
- Typical annual wholesale acquisition cost (WAC) of oral antipsychotics: $10,000 to $20,000 per patient.
- Ulotaront’s pricing could align with or slightly undercut current therapies if it offers similar efficacy with fewer side effects ([2]).
Early-Stage Pricing Assumptions
- Estimated WAC: approximately $12,000 annually per patient.
- Discounted wholesale price for payers: approximately 70-80% of WAC, around $8,400 to $9,600.
- Cost to patients, after insurance and rebates, may range between $0-$2,000 annually.
Revenue Projections (Post-Approval)
| Year |
Estimated Market Share |
Revenue (USD) |
Key Assumptions |
| Year 1 |
10% |
$200-300M |
Launch freshness, initial prescriber adoption |
| Year 2 |
15-20% |
$500-800M |
Increased market penetration, expanded indications |
| Year 3 |
25-30% |
$1B+ |
Greater clinician uptake, formulary inclusion |
Price Sensitivity
- Slight declines in price could occur due to increased generic competition or biosimilars.
- Discounts and rebates could reduce net revenue by 15-25% over projected estimates.
Risks and Uncertainties
- Regulatory delays: Approval post-2023 impacts revenue timelines.
- Market competition: Dominance by established brands could limit Ulotaront’s market share.
- Pricing pressure: Payer negotiations and discounting influence revenue.
Conclusions
- The drug’s market entry is contingent on successful FDA approval, expected late 2023 or early 2024.
- Initial revenues likely in the hundreds of millions of dollars.
- Pricing will resemble existing oral antipsychotics, around $8,000 to $12,000 annually per patient, with potential for adjustments based on market dynamics.
Key Takeaways
- NDC 76282-0334, associated with Ulotaront, shows promising market potential driven by unmet needs and a favorable clinical profile.
- Market entry is anticipated in late 2023, with projections indicating revenue between $200 million and $1 billion within three years.
- Pricing is aligned with current oral antipsychotics, with typical annual costs ranging from $8,400 to $12,000.
- Competition and regulatory factors pose primary risks.
FAQs
1. When is Ulotaront expected to gain FDA approval?
Approval is targeted for late 2023 or early 2024, contingent on successful Phase 3 trial results.
2. How does Ulotaront differ from existing antipsychotics?
It has a novel mechanism of action targeting trace amine-associated receptor 1 (TAAR1), potentially offering better tolerability.
3. What is the market size for schizophrenia treatments?
Approximately 2-3 million patients in the U.S., with the market valued at around $16 billion in 2022.
4. What are the main barriers to market success?
Regulatory approval, competition with established drugs, and payer reimbursement policies.
5. How might pricing evolve over time?
Initial pricing will likely be stable but could decrease due to generic competition or formulary negotiations.
References
[1] IQVIA. (2022). US Prescription Drug Market Overview.
[2] Goodman, D. (2022). The Pricing of New Antipsychotics. Journal of Pharmaceutical Economics.
