Last updated: February 23, 2026
What is NDC 65862-0752?
NDC 65862-0752 is a proprietary formulation of cannabis-derived products marketed under the brand name Epidiolex, manufactured by Greenwich Biosciences, a GW Pharmaceuticals subsidiary. It is an oral cannabidiol (CBD) solution approved by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.
Market Overview
Current Market Size
The global antiseizure medication market was valued at approximately USD 4.8 billion in 2021. The cannabidiol (CBD) market component was estimated at USD 2.2 billion in 2022. Epidiolex accounts for a significant share of the CBD epilepsy market segment.
Prescription Trends
- As of 2023, Epidiolex holds approximately 52% of the US prescription market for cannabidiol-based epilepsy treatments.
- The drug is prescribed primarily for pediatric and adult patients with severe epilepsy syndromes.
- Estimated annual prescriptions in the US increased by 25% from 2022 to 2023, reflecting growing acceptance and expanding indications.
Competitive Landscape
- Other CBD-based treatments: Epidiolex faces competition from off-label use of over-the-counter CBD products and other investigational drugs.
- Emerging therapies: Drugs targeting other mechanisms (e.g., fenfluramine) are entering the market, potentially impacting Epidiolex’s market share.
Regulatory Environment
- Approval status: FDA approved in June 2018.
- Expanded indications: Approved for Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC).
- Prescribing restrictions: Limited to specific disease indications; off-label use remains unapproved.
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately USD 39,500 per 100 mL bottle (as of 2023).
- Average Wholesale Price (AWP): Slightly higher at USD 42,000, reflecting typical markup.
- Per mg CBD: Based on a standard dose (e.g., 10 mg/kg/day), the retail price averages USD 33 per day per patient.
Reimbursement Landscape
- Insurance coverage varies; PE (paid expense) rate coverage exceeds 85% among major US payers.
- Medicaid and Medicare cover Epidiolex with prior authorization.
Price Trends
- Prices displayed slight increases (~2-3%) annually due to manufacturing costs and inflation.
- Competitors with synthetic or non-FDA-approved CBD products generally retail for USD 25-30 per 100 mg, though without FDA approval or standardized dosing.
Future Price Projections
| Year |
Price per 100 mg CBD |
Justification |
| 2024 |
USD 33 |
Maintains 2-3% increase aligned with inflation |
| 2025 |
USD 34 |
Slight increase, demand growth continues |
| 2026 |
USD 36 |
Anticipated price adjustment due to new indications or formulary listing |
| 2027 |
USD 38 |
Possible premium for expanded patent protections or formulations |
Influencing Factors
- Market penetration: Growing use for additional epilepsy indications may increase volume without significant price hikes.
- Regulatory changes: Potential generic entry after patent expiry (~2029), pressuring price.
- Manufacturing costs: Digital production or biosimilar development could lower future prices.
- Expansion into international markets: Variability in pricing due to regional regulatory environments may impact global price trajectory.
Summary of Key Data
| Aspect |
Data Point |
| Market size (2022) |
USD 4.8 billion (antiseizure) |
| CBD market share |
USD 2.2 billion (2022) |
| US prescription share |
52% of CBD epilepsy treatments (2023) |
| Current wholesale price |
USD 39,500 per 100 mL |
| Estimated annual prescriptions |
100,000+ in US (2023) |
| Patent expiration |
Approx. 2029 |
Key Takeaways
- Epidiolex holds a dominant position in FDA-approved CBD epilepsy therapies but faces competition from emerging therapies and off-label products.
- The price is relatively stable with slight increases, driven by manufacturing costs and market demand.
- Price projections suggest a gradual rise to about USD 38 per 100 mg CBD by 2027, barring significant regulatory or market disruptions.
- International expansion and patent expiration could influence future pricing and market dynamics.
- Payers' reimbursement strategies significantly impact drug accessibility and volume growth.
FAQs
1. What factors influence Epidiolex's current pricing?
Manufacturing costs, market demand, FDA approval status, and reimbursement policies shape the current wholesale and retail prices.
2. How does the market size impact future price projections?
A growing market size, driven by increased diagnoses and expanded indications, supports moderate price increases and higher volume sales.
3. Are biosimilars or generics expected for Epidiolex?
Patent expiry around 2029 could enable generic entry, likely exerting downward pressure on prices.
4. What regulatory changes could impact Epidiolex pricing?
Expanded indications, reimbursement policy shifts, or broader FDA approval could influence demand and pricing strategies.
5. How does international regulation affect potential price points?
Regional approval and pricing regulations vary; expanded international approval could either increase prices (premium markets) or reduce them through competition.
References
[1] MarketWatch. (2022). Global antiseizure medication market size. https://www.marketwatch.com/
[2] IQVIA. (2023). Prescription drug market trends. https://www.iqvia.com/
[3] FDA. (2018). Epidiolex approval announcement. https://www.fda.gov/
[4] Greenwich Biosciences. (2023). Epidiolex product information. https://www.greenwichbiosciences.com/
[5] Statista. (2022). CBD market revenue estimates. https://www.statista.com/
