Last updated: February 28, 2026
What is the drug associated with NDC 42806-0186?
NDC 42806-0186 corresponds to Epidiolex, a cannabidiol (CBD) oral solution approved by the FDA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, and tuberous sclerosis complex (TSC). Marketed by GW Pharmaceuticals (recently acquired by Jazz Pharmaceuticals), Epidiolex is the first CBD-based drug approved in the U.S.
What is the current market size?
Epidiolex's primary target markets include rare pediatric epilepsy, which has a constrained patient population but high unmet need.
- U.S. prevalence estimates:
- LGS: ~10,000 patients
- Dravet syndrome: ~2,000 to 3,000 patients
- TSC-associated seizures: ~20,000 to 30,000 patients
Total U.S. target population estimated at approximately 30,000 patients, with global markets expanding this figure significantly.
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Market penetration:
- Since its approval in September 2018, Epidiolex's U.S. sales reached approximately $400 million in 2022, with European and other markets contributing an additional $100 million.
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Competitive landscape:
- No direct CBD competitors approved for seizure indications.
- Conventional antiepileptic drugs like valproate, clobazam, and stiripentol are alternative treatments but exhibit differing efficacy and side-effect profiles.
What are the pricing trends?
U.S. Pricing Overview
- Average Wholesale Price (AWP):
- 100 mg/mL oral solution at launch in 2018: ~$32 per mL.
- Current average retail price: approximately $28-$30 per mL.
Dosage and Cost Calculations
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Typical dosing:
- 10-20 mg/kg per day, divided into twice-daily dosing.
- For an average patient (~70 kg), daily dose is around 700-1,400 mg.
- Monthly supply for 1,000 mg/day: roughly 60 mL.
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Monthly cost estimate:
- 60 mL x $29 per mL = $1,740.
- Annual cost: approximately $20,880.
European and Global Pricing
- European wholesale prices vary between €200 and €250 per 10-mL vial (e.g., in Germany and the UK).
- Pricing in other markets depends on local reimbursement policies and healthcare systems.
What are future price projections?
Market Dynamics
- Patent expiration: Epidiolex's patent protection expires in the early 2030s, opening the market to generics.
- Potential for price erosion:
- Entry of biosimilars or generic CBD formulations could reduce prices progressively by 20-50% over the next 3-5 years.
- Cost reductions:
- Manufacturing efficiencies and increased competition may lead to lower production costs.
Market Expansion
Revenue projections (2023-2027)
| Year |
Estimated Global Sales |
Approximate Price Range (per mL) |
Key Factors |
| 2023 |
$520 million |
$25-$28 |
Market maturity, patent protection ongoing, competitive landscape evolving |
| 2024 |
$600 million |
$22-$25 |
Patent expiration approaching, increased competition, expanding indications |
| 2025 |
$660 million |
$20-$23 |
Biosimilar entry, price erosion accelerates |
| 2026 |
$700 million |
$18-$21 |
Market saturation, competition intensifies |
| 2027 |
$750 million |
$15-$20 |
Widespread biosimilar adoption, evolving global markets |
(All figures are estimates based on historical data, market trends, and available forecasts.)
Regulatory and policy impacts
- Regulatory agencies (FDA, EMA) continue to approve CBD-based indications, encouraging market expansion.
- Reimbursement negotiations influence pricing, with payers favoring lower-cost alternatives.
- Legislation altering CBD classification or legal status could shift market dynamics significantly.
Key takeaways
- NDC 42806-0186 (Epidiolex) is a leading CBD-based drug for specific epileptic seizures.
- U.S. retail prices hover around $28-$30 per mL, with annual costs near $20,000 per patient.
- Global pricing varies, generally lower outside the U.S., depending on healthcare policies.
- Market revenues have grown steadily but face decline risk from patent expiration and generics.
- Price erosion is projected at 10-15% annually after patent expiry, with further reductions possible after biosimilar entry.
FAQs
Q1: Will Epidiolex's price decrease significantly after patent expiry?
A1: Yes, patent expiration typically enables generics, which generally lead to a 20-50% price reduction over several years.
Q2: Are biosimilars expected for Epidiolex?
A2: Biosimilars are unlikely due to the complex manufacturing of CBD formulations; but lower-cost generics may enter the market.
Q3: How does Epidiolex compare with traditional antiepileptic drugs in pricing?
A3: Although generally more expensive, Epidiolex's targeted indication and potential for better efficacy in certain populations justify its cost for many payers and providers.
Q4: What new indications could influence future pricing?
A4: Approved additional uses, such as for other forms of rare epilepsies or TSC, may sustain or increase prices.
Q5: How do international markets affect global revenue projections?
A5: Growing approval and reimbursement in Europe and Asia are expected to expand revenue streams, albeit at varying price points.
References
[1] U.S. Food and Drug Administration. (2018). FDA approves first drug Comprised of an active ingredient derived from cannabis to treat rare, severe forms of epilepsy. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-cannabis-treat-rare-severe-forms-epilepsy
[2] IQVIA. (2022). The IQVIA ophthalmic and neurological market data.
[3] European Medicines Agency. (2019). European approval for Epidiolex. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/epidiolex
[4] EvaluatePharma. (2022). 2022 World Preview - Outlook to 2027.
[5] MarketsandMarkets. (2021). Cannabidiol Market by Form, Application, and Region—Global Forecast to 2026.
