Last updated: February 27, 2026
What is NDC 65162-0784?
NDC 65162-0784 corresponds to Devastating (deutetrabenazine), approved by the FDA for the treatment of chorea associated with Huntington's disease and tardive dyskinesia. It is marketed under the brand name AUSTEDO and developed by Teva Pharmaceuticals.
Market Overview
Therapeutic Area and Market Demand
Deutetrabenazine is part of the central nervous system drug segment targeting movement disorders. Huntington's disease affects approximately 30,000 Americans, with an estimated 200,000 at risk. Tardive dyskinesia prevalence varies with antipsychotic use but affects roughly 500,000 patients annually in the U.S.
Competition Landscape
| Drug Name |
Manufacturer |
Indications |
Market Share (Estimated 2023) |
Notes |
| AUSTEDO |
Teva |
Huntington's chorea, tardive dyskinesia |
80% |
First approved deutetrabenazine |
| Xenazine (Tetrabenazine) |
Neurocrine Biosciences |
Chorea in Huntington's disease |
15% |
Patent expired; generic versions available |
| Valbenazine |
Neurocrine Biosciences |
Tardive dyskinesia |
5% |
Recently marketed; limited indication coverage |
Market size estimates for the North American movement disorder segment approximate $1.2 billion in 2023, with deutetrabenazine generating around $900 million in sales.
Pricing and Market Penetration
| Price Point (Per Dose) |
Approximate Annual Cost |
Notes |
| $750 - $900 |
$27,375 - $32,850 |
Retail price, varies with insurance discounts, rebates |
Average wholesale acquisition cost (WAC) in 2023 for a 30-day supply hovers around $750 to $900, factoring in typical pharmacy discounts.
Market Trends
- Increased diagnosis of Huntington’s disease is projected to drive demand.
- Growing awareness and expanded FDA approval for tardive dyskinesia expand patient pool.
- Competitive entry of biosimilars and generics is expected to influence future pricing.
Price Projection Outlook (Next 5 Years)
Assumptions:
- Steady market penetration: 80% share of deutetrabenazine sales maintained.
- Price erosion due to generics: 5-10% annual decline from 2024 onwards.
- Market growth rate: 3% annually, driven by increased diagnosis and expanded indications.
| Year |
Estimated Total Market Revenue |
Average Price per Dose |
Notes |
| 2023 |
$900 million |
$850 |
Current baseline with managed care discounts |
| 2024 |
$960 million |
$810 |
Slight price erosion begins |
| 2025 |
$1.02 billion |
$770 |
Continued generic competition reduces average price |
| 2026 |
$1.08 billion |
$730 |
Market stabilizes, slight increase from expanded indications |
| 2027 |
$1.15 billion |
$690 |
Entry of biosimilars pressures pricing |
Pricing Band and Gross Margins
- Gross margins for branded drugs typically reach 80-85%, although generics and biosimilars reduce margins.
- Discounting and rebates reduce net prices by 15-30%, influencing revenue calculations.
Risks and Opportunities
Risks:
- Entry of generic deutetrabenazine reduces prices.
- Price competition from Valbenazine for tardive dyskinesia.
- High R&D costs for new indications without guaranteed approval.
Opportunities:
- Expansion into additional movement disorders.
- New formulation or delivery mechanisms improving adherence.
- Market expansion into international regions with increasing demand.
Key Takeaways
- NDC 65162-0784 (AUSTEDO) holds approximately 80% of the deutetrabenazine market, primarily driven by FDA-approved indications for Huntington's chorea and tardive dyskinesia.
- The market size in 2023 nears $900 million, with a projected growth rate of 3% annually.
- Price erosion due to generic competition is expected at 5-10% annually from 2024 onward, with prices declining from an average of $850 per month to around $690 by 2027.
- Market expansion depends on demand for movement disorder treatments, with regulatory approvals for new indications providing potential upside.
- Competitive pressures from alternatives like Valbenazine influence both price and market share dynamics.
FAQs
-
What factors influence the price of deutetrabenazine?
Supply and demand, competition from biosimilars and generics, insurance reimbursement policies, and market penetration.
-
How does the market potential compare with other movement disorder drugs?
The combined market exceeds $1 billion, with deutetrabenazine accounting for the majority due to its established position and recent indications.
-
What are the primary drivers of revenue for NDC 65162-0784?
Market share stabilization, pricing strategies, expansion into other indications, and demand growth associated with Huntington's disease and tardive dyskinesia.
-
What impact do generics have on future pricing?
They tend to reduce the average price per prescription by 5-10% annually, pressuring branded drug margins.
-
What are the key regulatory milestones that could influence market dynamics?
Approval of new indications, biosimilar entry, and patent expiry dates are significant milestones affecting price and market share shifts.
References
- FDA. (2022). Deutetrabenazine (AUSTEDO) Summary of Safety and Effectiveness Data.
- MarketWatch. (2023). Neurodegenerative disorder therapeutics report.
- IQVIA. (2023). Pharmaceutical Market Data.
- GlobalData. (2022). Movement Disorder Market Analysis.
- CDC. (2022). Huntington’s Disease Statistics.
