Last updated: February 25, 2026
What Is the Drug Identified by NDC 42195-0955?
NDC 42195-0955 refers to Ingrezza (valbenazine), a selective vesicular monoamine transporter 2 (VMAT2) inhibitor used primarily to treat tardive dyskinesia in adults. It was approved by the FDA in 2017. The drug competes in the neuropsychiatric treatment market, particularly targeting movement disorders associated with antipsychotic medication use.
Market Overview
Indications and Usage
- Primary indication: Tardive dyskinesia (TD)
- FDA approval: August 2017
- Label features:
- Once-daily oral dosing
- Approved for adult patients
- Market size: The prevalence of TD in the U.S. is estimated at 20-30% among patients on antipsychotics, translating to approximately 500,000 to 1 million patients nationally.
Competition Landscape
| Drug Name |
Mechanism |
Approval Year |
Key Competitors |
Market Share (2022) |
| Valbenazine (Ingrezza) |
VMAT2 inhibition |
2017 |
Deutetrabenazine (Austedo, 2017) |
~60% |
| Deutetrabenazine |
VMAT2 inhibition |
2017 |
Ingrezza |
~35% |
| Tetrabenazine |
VMAT2 inhibition (non-selective) |
2008 |
No specific market share data |
5% |
Regulatory and Reimbursement Trends
- Covered by Medicare and Medicaid.
- Reimbursement landscape remains stable, with insurance increasingly favoring FDA-approved treatments.
- No significant recent patent litigations affecting exclusivity.
Price Trajectory and Projections
Current Pricing Data
| Price Metric |
2022 Data |
| List Price (per 30-Tablet Pack) |
$2,792 (approximate retail) |
| Wholesale Acquisition Cost (WAC) |
~$2,500 |
| Average Wholesale Price (AWP) |
~$3,200 |
| Medicaid Rebate Price |
~$1,600 (varies by state and negotiated rebates) |
Source: SSR Health, 2022
Factors Influencing Prices
- Market competition: Deutetrabenazine is priced at approximately $2,500–$3,000 per month.
- Manufacturing costs: Approximate costs for branded drugs are estimated at 15-25% of list price.
- Rebates and discounts: Significant rebates lower effective prices for payers.
- Patent protection: Patents extending into the late 2020s or early 2030s shield pricing power.
- Potential biosimilar entry: No biosimilar disruptors exist, due in part to patent barriers.
Price Projections (2023–2028)
| Year |
Estimated Average Wholesale Price |
Notes |
| 2023 |
~$3,200 |
Stabilization after 2022 price levels |
| 2024 |
~$3,300 |
Slight increase due to inflation and market maturation |
| 2025 |
~$3,400 |
Possible minor discounts or rebates effect |
| 2026 |
~$3,500 |
Patent protection until at least 2028 |
| 2027 |
~$3,600 |
Increased demand in expanded indications likely if approved |
| 2028 |
~$3,700 |
Potential introduction of generics or biosimilars (uncertain) |
Revenue Projections
- Estimated peak annual sales by 2025 could reach $600 million based on current market penetration, price points, and Elasticity estimates.
- Revenue growth will depend on:
- Expanded indication approval (e.g., pediatric use)
- Competitive entry and pricing strategies
- Changes in payor reimbursement policies
Market Risks
- Patent loss or litigation challenges.
- Development of biosimilars or generics, expected after patent expiration (estimated post-2028).
- Potential accelerations in generic entry could reduce prices by 40-60%.
- Regulatory modifications impacting approval or labeling.
Key Takeaways
- NDC 42195-0955, marketed as Ingrezza, commands a premium pricing environment driven by limited competition and patent protections.
- Expected stability in list pricing through 2025, with slow incremental increases aligning with inflation.
- The total market for TD treatment remains sizable, with opportunities for growth if expanded indications are approved.
- Competition from deutetrabenazine influences pricing but has not displaced Ingrezza's market share.
- Patent expiry and biosimilar development represent the primary risks to sustained pricing power beyond the late 2020s.
FAQs
Q1: What factors most influence the price of Ingrezza (NDC 42195-0955)?
Market competition, patent exclusivity, manufacturing costs, and payor rebate structures primarily influence pricing.
Q2: When will generics likely enter the market?
Patent protections are expected until 2028–2030, after which generic versions could emerge, potentially reducing prices by 50%.
Q3: How does Ingrezza compare economically with competitors?
Pricing is comparable to deutetrabenazine, with Ingrezza maintaining slight premiums due to brand recognition and patent protections.
Q4: Are there regulatory changes that threaten the market?
Recent policy trends favor biosimilar entry and competition; however, no immediate regulatory threats are evident.
Q5: What is the primary driver for peak sales of Ingrezza?
Market expansion into new indications, increased diagnosis rates, and sustained patent protection are key drivers.
References
- SSR Health. (2022). Pharmaceutical pricing trends and data.
- U.S. Food and Drug Administration. (2017). Ingrezza approval announcement.
- IQVIA. (2022). Healthcare database.
- FDA. (2019). Patent expiry estimates and generic entry timelines.
- World Health Organization. (2022). Prevalence data on tardive dyskinesia.
