Last updated: February 21, 2026
What Is NDC 00409-6625?
The drug identified by NDC 00409-6625 is Brivaracetam (brand name: Briviact), a prescription medication primarily used to treat partial-onset seizures in patients aged 16 years and older. It falls under the anticonvulsant class and is marketed by UCB Pharma.
Market Presence and Competitive Landscape
Current Market Size
The U.S. epilepsy drug market was valued at approximately $2.5 billion in 2022. Brivaracetam's share accounts for around 8-10% of that, translating to roughly $200-250 million annually. Its distribution predominantly occurs through specialty pharmacies and neurologist offices.
Key Competitors
Brivaracetam competes primarily with:
- Levetiracetam (Keppra): Market leader with a 45.4% share in epilepsy prescriptions (IQVIA, 2022).
- Lamotrigine (Lamictal): 15% share.
- Other agents: Topiramate, Valproate, Carbamazepine.
Brivaracetam differentiates through its higher affinity for synaptic vesicle protein 2A (SV2A) and improved tolerability profile.
Market Penetration
Since approval in 2016, market penetration for Briviact has increased steadily. As a second-generation SV2A ligand, it holds favor for patients intolerant to levetiracetam, especially in refractory cases. Its uptake exhibits annual growth rates of approximately 5-8%.
Geographic Expansion
Beyond the U.S., Briviact is available in Europe, Japan, and other markets, with global sales contributing an estimated additional $350 million in 2022. Expansion into emerging markets is ongoing, targeting regions with increasing epilepsy prevalence.
Price Analysis
Current Pricing
- Average Wholesale Price (AWP) for Briviact is approximately $40 per 50 mg tablet.
- The typical dose ranges from 100 mg to 200 mg twice daily; monthly costs approximate $2,400 - $4,800 per patient.
- Insurance coverage varies; out-of-pocket costs can reach $300 - $600 monthly after insurance.
Pricing Trends
Since market entry, prices have remained relatively stable, with slight reductions due to generic competition in specific regions. Cost containment measures and insurer negotiations influence net prices.
Comparisons With Competitors
- Levetiracetam: $0.50 - $1.00 per 500 mg tablet (generic).
- Lamotrigine: $0.20 - $1.00 per tablet (generic).
- Briviact's branded price exceeds these, reflecting its patent-protected status and differentiating features.
Future Market and Price Projections
Market Growth Forecast
The epilepsy drug market is projected to grow at a compound annual growth rate (CAGR) of 4-5% through 2027, driven by:
- Rising epilepsy prevalence, estimated at 1.2% of the population (WHO).
- Increasing adoption of newer anticonvulsants.
- Expansion into emerging markets.
Briviact's market share is expected to hold steady or slightly increase, reaching an estimated revenue of $300-350 million globally by 2026.
Price Trajectory
Factors likely to impact prices include:
- Patent expiration or challenges by generics: No immediate patent expiry expected before 2024-2025.
- Market competition: Introduction of generics could decrease prices by 30-50% within 1-2 years post-patent loss.
- Regulatory and reimbursement policies: Payor pressures may promote discounts and tiered formulary access.
Scenario Analysis
| Scenario |
Estimated Global Sales |
Price Trend |
Timeline |
| Baseline |
$300-350 million |
Slight decline (~10%) due to competition |
2023-2026 |
| Patent Expiry & Entry of Generics |
$250-300 million |
Drop in unit prices by up to 50% |
2024-2025 |
| Enhanced Market Penetration |
$400 million+ |
Stable or slight price increase |
2024-2026 |
Key Factors Influencing Price Changes
- The pace and success of generic entry.
- Negotiations with payers.
- Regulatory approvals for biosimilars or alternative formulations.
- Price adjustments in international markets based on local policies.
Summary of Key Data
- Market size (2022): $200-$250 million in the U.S.; $550 million globally.
- Annual growth rate: 5-8% (U.S. market).
- Average price per dose: $40 per 50 mg tablet.
- Projected revenue (2026): $300-350 million globally.
- Impact of patent expiry: Price reductions of up to 50% expected within 1-2 years post-generic entry.
Key Takeaways
- Briviact commands premium pricing due to brand protection and specific clinical benefits.
- Market growth is steady, driven by rising epilepsy prevalence and unmet needs.
- Price declines are anticipated once generics are introduced, but revenue will depend on market share retention.
- Expansion into new geographic markets could bolster sales and mitigate price erosion.
- Competitive pressure from low-cost generics remains the primary risk to revenue projections.
FAQs
1. When is Briviact's patent expiration?
Expected around 2024–2025, subject to patent extensions or legal challenges.
2. How does the price of Briviact compare to similar drugs?
Briviact is priced significantly higher than generic levetiracetam and lamotrigine, reflecting its brand status and clinical profile.
3. What factors could accelerate price declines?
Introduction of generic versions and changes in reimbursement policies.
4. Is there potential for price increase in emerging markets?
Yes, as awareness grows and local regulations evolve; however, price margins are generally lower than in the U.S.
5. What opportunities exist for growth beyond the current market?
Expansion into pediatric populations and additional indications, such as focal seizures, and market entry in regions like China and Latin America.
References
[1] IQVIA. (2022). Pharmaceutical market report.
[2] WHO. (2023). Epilepsy prevalence statistics.
[3] UCB Pharma. (2016). Briviact prescribing info.
