Last updated: February 23, 2026
What is the Drug NDC 00904-7496?
NDC 00904-7496 corresponds to Brivaracetam, marketed under the brand name Briviact. It is an antiepileptic medication approved by the FDA for adjunctive treatment of partial-onset seizures in patients aged 16 and older. Brivaracetam is a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand, which reduces neuronal excitability.
Market Scope and Competitive Landscape
Key Indications
- Partial-onset seizures in adults
- Adjunctive therapy in epilepsy management
- Investigational uses include other seizure types
Market Size Estimates
As of 2022, the global epilepsy treatment market was valued at approximately $4.6 billion. The US accounted for approximately 70% of the market, with an estimated value of $3.22 billion.
- US Epilepsy Market (2023): Approximate sales of $3.2 billion; growing at a compounded annual growth rate (CAGR) of 4% over the past five years.
- Market Penetration of Briviact: Estimated at 15-20%, considering competing therapies.
Key Competitors
| Drug Name |
Market Share (2022) |
Pricing (per month) |
Approved Uses |
| Levetiracetam |
25% |
$250 |
Partial, generalized seizures |
| Lamotrigine |
20% |
$200 |
Partial, bipolar disorder |
| Topiramate |
10% |
$220 |
Partial, migraine prevention |
| Brivaracetam |
5-7% |
$370 |
Partial-onset seizures |
Brivaracetam faces competition primarily from levetiracetam (Keppra), with a slightly higher price point.
Pricing Trends and Projections
Current Pricing
- The average wholesale price (AWP) in 2023 for Briviact in the US is approximately $370 per month.
- Medicare and private insurer rebates can reduce out-of-pocket costs for patients.
Price Drivers
- Regulatory Approvals: Broader indications (e.g., monotherapy, generalized seizures) may support price increases.
- Market Penetration: Greater adoption in pediatric or other populations could raise revenue.
- Competitive Pressure: Price reductions may occur if generics or biosimilars emerge.
Patent Status and Biosimilar Impact
- Briviact’s patent expiry is expected post-2030.
- No biosimilar competition anticipated soon; however, the presence of generics for lixetil (active ingredient) could influence pricing.
Price Projections (2023-2028)
| Year |
Estimated Monthly Price |
Notes |
| 2023 |
$370 |
Current market price |
| 2024 |
$355-$370 |
Slight downward pressure from generic entry |
| 2025 |
$340-$355 |
Possible generic competition impacts |
| 2026 |
$330 |
Standard inflation adjustments |
| 2027 |
$320 |
Increased market penetration possibly stabilizes prices |
| 2028 |
$310 |
Further generic influence, volume-driven gains |
Revenue Projections
- Based on current market share and pricing, US sales are projected to range between $600 million and $800 million annually through 2028.
- Global sales could reach $1.2 billion, factoring in emerging markets.
Regulatory and Market Access Considerations
- Insurance coverage, formulary inclusion, and patient assistance programs significantly influence actual revenue.
- Proposed formulations and administration routes impact market uptake.
- FDA's approval expansion can facilitate price increases and higher market share.
Key Takeaways
- Briviact (NDC 00904-7496) remains a niche but growing segment within epilepsy treatments.
- Its higher price point compared to competitors is supported by presumed superior efficacy or tolerability, though competitive market share is limited.
- Price declines are likely post-patent expiry, with an ongoing focus on expanding indications and formulary access to sustain revenue.
- The US market remains the primary revenue driver with potential growth in international markets.
- Market penetration relies heavily on insurer reimbursement policies and physician prescribing trends.
FAQs
-
What factors could influence the future price of Briviact?
Regulatory expansion, patent status, generic entry, and payer reimbursement policies directly influence pricing.
-
How does Briviact compare to similar medications in efficacy?
Clinical data suggest comparable efficacy to levetiracetam, with some reports of better tolerability, supporting premium pricing.
-
What is the risk of generic competition?
Patent expiry after 2030 presents a moderate risk; no generics are currently available.
-
Are there emerging markets likely to impact revenue?
Yes, Asia-Pacific and Latin American regions show growth potential, although price sensitivity may differ.
-
How may formulary access affect revenue projections?
Wider formulary inclusion and favorable negotiation with payers can enhance sales volume and currency value.
References
[1] MarketWatch. (2022). Epilepsy Treatment Market Size, Share & Trends, 2022-2030.
[2] IQVIA. (2023). US Prescription Data for Antiepileptic Drugs.
[3] U.S. Food and Drug Administration. (2020). Brivaracetam (Briviact) FDA Approvals and Labeling.
