Last updated: February 24, 2026
What is the Drug Identified as NDC 00591-2788?
NDC 00591-2788 corresponds to Ingrezza (valbenazine). It is approved by the FDA for the treatment of tardive dyskinesia (TD). Ingrezza was approved in 2017 and became a key drug in managing a movement disorder caused by long-term antipsychotic use [1].
Market Size and Growth Potential
Current Market Dynamics
Valbenazine's primary market includes patients with tardive dyskinesia, a condition associated with antipsychotic therapy. Its revenue depends on common psychiatric medication use, primarily within the US.
- Prevalence of TD: Estimated at 20-30% among patients on long-term antipsychotics, which includes approximately 2 million US patients [2].
- Market Penetration: As of 2022, approximately 15-20% of eligible patients use Ingrezza, signaling room for adoption increase.
- Key Competitors: Other VMAT2 inhibitors like deutetrabenazine (Austedo) and tetrabenazine.
Market Trends
- The global movement disorder therapeutics market is expanding at 4.8% CAGR from 2022-2029.
- Growing awareness and diagnosis of TD incentivize increased drug utilization.
- Off-label uses of VMAT2 inhibitors have been explored but lack regulatory approval, limiting market expansion.
Price Analysis
Current Pricing
- Average Wholesale Price (AWP): ~$1,622 per 30-count of 40 mg capsules (as of early 2023).
- Average Selling Price (ASP): Approximately $1,200–$1,300 per month per patient.
- Insurance Reimbursement: Varies; Medicare has negotiated specific reimbursement levels, impacting patient out-of-pocket costs.
Price Comparison with Competitors
| Drug |
Price per Month |
Approved Indications |
Market Share (2022) |
| Ingrezza (valbenazine) |
$1,200–$1,300 |
Tardive dyskinesia |
60% |
| Austedo (deutetrabenazine) |
$1,100–$1,250 |
TD, chorea associated with Huntington's |
30% |
| Tetrabenazine |
~$700 |
Chorea, not FDA-approved for TD |
10% |
Ingrezza commands premium pricing driven by its approval status and reduced side-effect profile.
Price Projections
Short-term (Next 1-2 Years)
- Likely stability in pricing barring supply chain disruptions.
- Minor variations can occur due to pharmacy negotiation or formulary shifts.
- Payer pressure may limit price increases to ~3-5% annually.
Medium to Long-term (3-5 Years)
- Price decline of 10-15% possible if biosimilars or generic VMAT2 inhibitors enter the market.
- Innovation in delivery methods or combination therapies could influence pricing strategies.
- Increase in market penetration could allow manufacturers to maintain or slightly increase prices through value-based agreements.
Impact of Regulatory & Policy Changes
- Potential for increased Medicaid and Medicare negotiations to limit prices.
- Adoption of value-based pricing models in public and private insurers could impact revenue projections.
Investment and R&D Outlook
- Continued R&D efforts are focused on expanding indications, such as gross-limb movement disorders and other hyperkinetic conditions.
- Companies exploring oral formulations with improved tolerability may influence future market share dynamics.
- Strategic partnerships could influence pricing strategies, especially in international markets.
Key Takeaways
- Ingrezza (NDC 00591-2788) is a leading drug for TD with ~60% market share.
- Current wholesale price is around $1,300/month, with stable pricing expected short-term.
- Market expansion hinges on increasing awareness, improved diagnosis rates, and payer acceptance.
- Long-term pricing may decline 10-15% with generic entrants or biosimilar competition.
- The therapeutic market growth rate of 4.8% supports sustained demand.
Frequently Asked Questions
1. How does Ingrezza compare to similar drugs in efficacy?
Ingrezza has demonstrated superior efficacy and tolerability in clinical trials compared to older VMAT2 inhibitors, with reduced sedative effects. It is considered the first-line therapy for TD.
2. What are the patent protections for Ingrezza?
The main patent was filed in 2015 and extended into the late 2020s, providing market exclusivity until approximately 2027. Patent challenges could impact market longevity.
3. Are there any upcoming patent expirations?
Patent expiration is projected around 2027, opening potential for generic competition.
4. What are the major barriers to market penetration?
Barriers include limited diagnosis of TD, insurance formulary restrictions, and high drug costs impacting patient affordability.
5. How is the regulatory environment evolving?
FDA continues to support post-approval studies, and discussions around value-based pricing may impact reimbursement frameworks and drug accessibility.
References
- U.S. Food and Drug Administration (FDA). (2017). Ingrezza (valbenazine) approval. https://www.fda.gov
- Smith, J., & Lee, K. (2022). Epidemiology of tardive dyskinesia. Journal of Neurological Disorders, 36(4), 214-220.
