Last updated: April 4, 2026
What is NDC 50268-0607?
NDC 50268-0607 refers to Ingrezza (valbenazine), a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the FDA for treating tardive dyskinesia. It is marketed by Neurocrine Biosciences.
Market Size and Growth Drivers
Indication and Patient Population
- Tardive dyskinesia (TD): A movement disorder caused by long-term use of antipsychotic drugs.
- Estimated prevalence in the US: 500,000 to 1 million patients.
- Therapeutic need: Limited effective treatments prior to Ingrezza, with considerable unmet demand.
Market Penetration
- Launched in 2017.
- Market share growth: Approximately 45% within the specialty psychiatric segment in 2022.
- Reimbursement landscape: Positive, with inclusion in major formularies such as Medicare Part D and commercial plans.
Competitive Landscape
- Key competitors include: Deutetrabenzine (Austedo), anticholinergics, and off-label treatments.
- Ingrezza's advantages include selective mechanism and tolerability.
Revenue and Volume Trends
| Year |
Estimated US Sales (USD millions) |
Market Share (%) |
Units Sold (approximate) |
| 2017 |
$50 |
10 |
150,000 |
| 2018 |
$200 |
25 |
600,000 |
| 2019 |
$550 |
40 |
1.7 million |
| 2020 |
$750 |
42 |
2.3 million |
| 2021 |
$1.2 billion |
45 |
3.8 million |
| 2022 |
$1.4 billion |
45 |
4.5 million |
Note: Figures are estimates based on market reports and sales data from industry sources.
Drivers of Revenue Growth
- Increasing awareness and diagnosis.
- Expansion into additional indications (e.g., schizophrenia-related TD).
- Broader insurance coverage.
- Ongoing physician education.
Price Projections
Wholesale Acquisition Cost (WAC) and Reimbursement
- Current WAC (2023): ~$7,000 per month per patient.
- Average net price after rebates and discounts: ~$6,500 per month.
- Typical treatment duration: Chronic, leading to sustained revenue streams.
Price Trends
- Price stability observed since launch.
- Potential for gradual increases due to inflation and manufacturing costs.
- High penetration could trigger price adjustments based on payer negotiations.
Future Pricing Scenarios
| Scenario |
WAC Estimate |
Rationale |
Timeline |
| Status Quo |
~$7,000/month |
Market maturity, stable competition |
2023–2025 |
| Mild Increase |
~$7,300/month |
Inflation, increased demand |
2025–2027 |
| Price Sensitivity |
~$6,800/month |
Payer pressure, entry of biosimilars |
2025–2027 |
Note: No biosimilars are currently projected for Ingrezza due to its differentiated mechanism and patent protections.
Regulatory and Market Risks
- Patent protection extending into the late 2020s.
- Possible price controls or drug importation policies.
- Off-label competition or new therapies entering the market.
Key Takeaways
- The US market for NDC 50268-0607 is expected to reach approximately $1.4 billion in 2022, with stable growth driven by increased diagnosis and acceptance.
- Prices are likely to remain steady with modest increases, conditioned on payer negotiations and inflation.
- The patient population's unmet needs and the drug's approval for new indications position it for sustained revenue growth.
- Competition and regulatory changes pose potential risks to market share and pricing.
FAQs
1. What is the primary indication for NDC 50268-0607?
Tardive dyskinesia, a movement disorder associated with long-term antipsychotic use.
2. What is the current annual revenue estimate for Ingrezza?
Approximately $1.4 billion in 2022 in the US.
3. Are biosimilars likely for Ingrezza?
No, due to the specific mechanism and patent protections. Biosimilar competition is unlikely before patent expiry.
4. What factors can influence future pricing?
Payer negotiations, inflation, competitive dynamics, and regulatory policies.
5. When does patent protection for Ingrezza expire?
Patent protection extends into the late 2020s, with exclusivity until approximately 2028–2030.
References
- U.S. Food and Drug Administration. (2017). Ingrezza (valbenazine) label.
- IQVIA. (2022). Market data for neuropsychiatric medications.
- Neurocrine Biosciences. (2023). Annual report and investor presentation.
- EvaluatePharma. (2022). World market projections for neurological treatments.
- Medicare Part D formulary listings.
