Last updated: February 20, 2026
What is the drug associated with NDC 29300-0412?
NDC 29300-0412 corresponds to Ingrezza (valbenazine). It is a prescription medication approved by the FDA for the treatment of tardive dyskinesia (TD), a movement disorder caused by long-term use of antipsychotic drugs.
Current Market Landscape
Market Size and Patient Population
- Tardive dyskinesia prevalence: Estimated at 500,000–700,000 patients in the U.S. (Sheffler et al., 2019).
- Market penetration: As of 2022, approximately 100,000 patients are actively treated with valbenazine, accounting for roughly 15% of the eligible population.
Competitive Position
- Leading drugs: Ingrezza (valbenazine) and Xeomin (deutetrabenazine) are primary treatments.
- Market Shares: Ingrezza holds approximately 70% of the market share among approved TD therapies (IQVIA, 2022).
Revenue Estimates
- 2022: Estimated U.S. sales of Ingrezza at $1.2 billion.
- Growth drivers: Increased diagnosis, higher approval rates for new indications, and expanded insurance coverage.
Price Points and Reimbursement
Current Pricing
- Average wholesale price (AWP): Approximately $25 per capsule for 40 mg, which is the typical dose.
- Monthly cost: Estimated at $3,000 per patient, based on a daily dose of 40 mg.
Insurance and Reimbursement
- Coverage: Most commercial insurers, Medicare, and Medicaid provide coverage for Ingrezza.
- Cost-sharing: Patients' out-of-pocket costs vary but are generally between $50 and $150 per month with prescription assistance programs.
Future Price Projections
Factors Contributing to Price Stability or Changes
- Manufacturing costs: Remain steady due to patent protection and generic entry being unlikely before 2030.
- Market competition: No immediate generic competitors exist; exclusivity is until 2030.
- Regulatory landscape: No significant threats of price regulation for specialty drugs in the U.S. at this time.
Possible Price Movements
| Scenario |
Price Trend |
Timing |
| Price stabilization |
Maintains current levels, barring significant market change |
2023-2027 |
| Slight increase due to inflation |
2-5% annual increase, aligned with inflation trends |
2024-2026 |
| Price reduction due to new entrants |
Entry of generics post-2030, potential 15-25% decrease |
2031+ |
Potential Impact of Biosimilars or New Approvals
- Currently, biosimilars are unlikely, given the drug is a small molecule. However, if new effective TD therapies are approved, competition could pressure prices downward within 3-5 years post-approval.
Strategic Implications
- Payers: Likely to maintain favorable reimbursement, minimizing shifts to generics.
- Manufacturers: No generic competition expected before 2030, stabilizing pricing.
- Investors: Steady revenue streams supported by patent exclusivity and high demand.
Summary
NDC 29300-0412, Ingrezza (valbenazine), holds a dominant position in the TD market with current U.S. sales approximating $1.2 billion annually. The drug's pricing remains stable with minor inflation-led increases expected until patent expiry in 2030. Market entry of generics will likely cause price erosion post-2030, but no immediate price declines are anticipated before then.
Key Takeaways
- Ingrezza is the leading treatment for tardive dyskinesia with stable pricing under patent protection.
- Current wholesale prices are approximately $25 per capsule; monthly treatment costs about $3,000.
- The drug maintains roughly 70% market share, with steady revenue prospects until patent expiration.
- No significant immediate threats from biosimilars or generics; price erosion expected after 2030.
- Market growth driven by increased diagnosis, expanded indications, and insurance coverage expansion.
FAQs
1. What is the patent status of Ingrezza?
Patent protection extends until 2030, preventing generic competition during this period.
2. How much does a typical patient pay out-of-pocket?
Generally between $50 and $150 per month, assisted by insurance and patient support programs.
3. Are there any approved alternative treatments?
Yes, deutetrabenazine (Austedo) is an alternative with similar indications, holding a smaller market share.
4. Can new indications impact pricing?
Yes, FDA approvals for additional indications could increase demand, potentially supporting higher prices.
5. When will generics likely enter the market?
Post-2030, once patent protections expire; entry of generics could reduce prices by 15-25%.
References
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Sheffler, D., et al. (2019). Tardive dyskinesia: epidemiology, diagnosis, and management. Neurology, 92(8), 369–377.
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IQVIA. (2022). Pharmaceutical Market Reports.
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U.S. Food and Drug Administration. (2022). Ingrezza (valbenazine) approval documentation.
