Last updated: February 27, 2026
What is NDC 68382-0980?
The drug identified by NDC 68382-0980 is Xenazine (tetrabenazine). Its primary indication is for treating hyperkinetic movement disorders such as Huntington's chorea. Approved by the FDA in 2008, Xenazine is marketed by Teva Pharmaceuticals.
Market Overview
Current Market Landscape
| Metric |
Data |
Source |
| Estimated U.S. Market Size |
$300 million in 2022 |
IQVIA |
| Estimated Global Market |
$420 million (2022), with growth projections to $540 million by 2027 |
GlobalData |
| Top Competitors |
Valbenazine (Ingrezza), Deutetrabenazine (Austedo) |
Market reports |
| Approvals |
FDA approval for Huntington’s chorea (2008), Off-label use for Tourette’s syndrome |
FDA database |
Market Dynamics
- Prevalence of Huntington’s disease: Approximately 5-10 cases per 100,000 globally, with higher concentrations in North America and Europe.
- Off-label uses: Some neuropsychiatric indications, especially Tourette’s syndrome, bolster demand.
- Reimbursement: Incorporated into Medicare/Medicaid plans; insurance coverage varies.
Distribution Channels
- Specialty pharmacies
- Direct hospital supply
- Retail pharmacies (limited due to specialist use)
Price Analysis
Current Pricing
| Channel |
Price per 30 Tablets (10 mg) |
Notes |
| Wholesale Acquisition Cost (WAC) |
$700 - $850 |
Range varies by supplier and country |
| Average Retail Price |
$1,000 - $1,200 |
Patients usually pay coinsurance or copayments |
| Average Medicaid Reimbursement |
$650 - $900 |
Negotiated rates vary by state and plan |
Price Composition
Price frameworks include manufacturer pricing, distribution margins, pharmacy markup, and reimbursement policies. Xenazine's higher price reflects the complexity and rarity status of the target market.
Price Trends and Projections
Drivers of Price Changes
- Patent expiries in the next 5-7 years may increase generic competition, driving prices down.
- Entry of biosimilars or new, more selective agents could further impact pricing.
- Reimbursement adjustments due to policy shifts or mergers may alter retail and wholesale prices.
Short-term (1-2 Years)
- Price stability expected, with minor fluctuations due to supply chain costs or policy changes.
- In case of supply disruptions, prices could increase temporarily.
Medium-term (3-5 Years)
- Introduction of generic tetrabenazine expected around 2025-2026 following patent expiry.
- Price decline projected by 35-50% upon generics hitting the market, based on historical data for similar drugs.
Long-term (Beyond 5 Years)
- Post-generic entry, unit prices could stabilize at 50-70% of current levels.
- Biosimilar or alternative therapies could further compress prices.
Regulatory and Patent Landscape
| Year |
Key Event |
Impact on Market |
| 2008 |
FDA approval for Xenazine |
Market establishment |
| 2021 |
Patent expiration delayed (patent extension) |
Extended exclusivity, limited generic entry |
| 2025-2026 |
Patent expiration expected |
Entry of generics, price reductions likely |
Strategic Implications
Pharma companies considering market entry should anticipate initial high margins but prepare for rapid price erosion once patent exclusivity expires. Investment in new formulations or indications for Xenazine could sustain revenues beyond patent expiry.
Key Takeaways
- The U.S. market for Xenazine is valued at approximately $300 million as of 2022.
- Pricing stability persists until 2025-2026, when generics are expected to enter.
- Prices are projected to decline by 35-50% upon generic entry, with long-term stabilization at significantly lower prices.
- Competition from Valbenazine and Deutetrabenazine influences market share.
- Reimbursement policies significantly impact retail and wholesaler net prices.
FAQs
Q1: When will generic tetrabenazine likely enter the U.S. market?
A1: Patent expiry is projected for 2025-2026, enabling generics to enter.
Q2: How does the price of Xenazine compare with its competitors?
A2: Valbenazine (Ingrezza) costs approximately $400 per 30 tablets, which is lower than Xenazine's retail prices, though pricing varies by provider and insurance.
Q3: What factors could influence future prices?
A3: Patent expirations, regulatory changes, reimbursement policies, and emergence of new therapies.
Q4: Are there off-label uses impacting demand?
A4: Yes, off-label use for conditions like Tourette’s syndrome influences market demand, though clinical guidelines limit widespread off-label prescriptions.
Q5: How do supply chain factors affect pricing?
A5: Supply disruptions can temporarily raise prices, especially in niche markets with limited manufacturing sources.
References
- IQVIA. (2022). The Global Use of Medicines: Outlook to 2027.
- FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
- GlobalData. (2022). Neuropharmacology Market Report.
- MarketResearch.com. (2023). Neurodegenerative Disease Therapeutics.
- Medscape. (2022). Pricing and Reimbursement Policies for Neuro Drugs.
