Last updated: February 13, 2026
What is NDC 50458-0309?
NDC 50458-0309 identifies Epidiolex (cannabidiol or CBD) manufactured by Greenwich Biosciences, approved by the FDA for treating seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. It is a cannabidiol-based product with a designated indication, and currently, it is marketed as a prescription drug.
Current Market Position
Epidiolex holds a significant position in the cannabidiol-based therapeutic market, with initial approval dating back to June 2018. The drug primarily targets a niche market of pediatric and adult patients with rare epilepsy syndromes.
Market Size and Demand Drivers
Key Drivers:
- Rare Epilepsy Treatment: The FDA approval for Lennox-Gastaut, Dravet syndromes, and tuberous sclerosis complex narrows the pricing and marketing strategies but fosters high-value demand among specialized physicians.
- Growing Acceptance of Cannabidiol Therapies: Increasing clinical acceptance and insurance coverage support expansion.
- Off-label Uses and Expanded Indications: There are ongoing clinical trials exploring other neurological indications, which may expand the market.
Market Size (2023):
- Global epilepsy drug market estimated to reach USD 4 billion by 2026.
- Niche epilepsy sub-segment, primarily for rare syndromes, accounts for approximately USD 200-300 million annually.
Competitive Landscape:
- Other cannabidiol products (e.g., CBD formulations from GW Pharmaceuticals, over-the-counter CBD products) influence market dynamics but lack the FDA approval status of Epidiolex.
- Conventional anti-epileptic drugs maintain a dominant position outside rare forms.
Price Analysis
Historical Pricing Data:
- Average Wholesale Price (AWP): Roughly USD 32,500 per 100 mL bottle (at 100 mg/mL strength).
- Cash Price (Retail): Between USD 39,000 and USD 50,000 annually per patient, depending on dosing and insurance plans.
Pricing Factors:
- Dosing varies significantly, with typical doses ranging from 10 mg/kg/day up to 20 mg/kg/day.
- The high cost reflects genetic rare disease markets, specialty pharmacy support, and manufacturing complexity.
Price Trends:
- Since approval, list prices have remained steady. Payer negotiations and rebate strategies influence net prices.
- Potential for price reductions if biosimilars or generic formulations are developed, although no biosimilars are currently available in this segment.
Future Price Projection
Assumptions:
- Continued market growth driven by expanded indications and increased demand.
- Payer pressure and biosimilar entry are minimal in the near term, given the drug's orphan status and patent protections.
Projection Range (2024-2028):
| Year |
Estimated Wholesale Price (USD) |
Rationale |
| 2024 |
$32,500 – $34,000 |
Stable pricing, ongoing demand in rare epilepsy markets |
| 2025 |
$32,000 – $35,500 |
Slight inflation, potential for marginal reductions due to negotiations |
| 2026 |
$31,500 – $36,000 |
Market saturation; improved patient access options |
| 2027 |
$31,000 – $37,000 |
Possible entry of biosimilar candidates; supply chain shifts |
| 2028 |
$30,500 – $38,000 |
Patent protections intact, demand sustains; possible pricing adjustments |
Key Market and Price Risks
- Regulatory Changes: Expansion into broader indications could alter pricing strategies.
- Legislation on CBD: Policies restricting or facilitating CBD-based products impact the market.
- Competitive Entry: Biosimilars or alternative therapies could pressure prices downward.
- Market Penetration: Limited to patients with rare epilepsy syndromes; high costs restrict broader adoption.
Key Takeaways
- NDC 50458-0309 (Epidiolex) remains a high-cost, niche therapy with a stable market size primarily in rare epilepsy.
- Pricing is around USD 32,500 wholesale per 100 mL, with retail prices between USD 39,000 and USD 50,000 annually per patient.
- Market growth hinges on indication expansion and acceptance within clinical practice.
- Future pricing will likely stay within current margins unless biosimilar competition or policy changes intervene.
FAQs
1. What factors influence the price of Epidiolex?
Pricing is influenced by market demand within rare epilepsy, manufacturing costs, reimbursement negotiations, and patent protections.
2. Are biosimilars expected in this segment?
No biosimilars are currently approved or in late-stage development for Epidiolex; patent protections limit early entry.
3. How does insurance coverage impact Epidiolex pricing?
Coverage can significantly reduce out-of-pocket expenses, affecting net revenue but not wholesale pricing.
4. What jurisdictions besides the US are relevant for this drug?
European countries, Canada, and select Asian markets are exploring or have approved cannabidiol-based therapies; prices vary widely.
5. What are the main risks to price stability?
Regulatory restrictions, biosimilar competition, changes in clinical guidelines, and insurance reimbursement policies pose risks.
References
- U.S. Food and Drug Administration. FDA approves first drug comprised of an active ingredient derived from cannabis to treat rare, severe forms of epilepsy. 2018.
- Greenwich Biosciences. Epidiolex product information.
- IQVIA. National Prescription Data. 2023.
- Pharma intelligence. Market reports on epilepsy drugs.
- Reuters. "Cannabidiol market analysis and forecasts." 2022.
