Last updated: March 13, 2026
What is the Drug with NDC 65862-0837?
NDC 65862-0837 corresponds to Brivaracetam (Briviact), an antiepileptic drug manufactured by UCB. It is approved by the FDA for the adjunctive treatment of partial-onset seizures in patients aged 16 years and older.
Current Market Position
Market Size
- The global epilepsy market is valued at approximately $4.2 billion in 2022.
- U.S. sales for Briviact reached $485 million in 2022, a 6% increase from 2021.
- Estimated annual prescriber penetration in the U.S. is around 300,000 patients.
Competitive Landscape
Briviact faces competition mainly from:
| Drug Name |
Indication |
Market Share (2022) |
Price Range (per unit) |
| Levetiracetam (Keppra) |
Partial seizures, general epilepsy |
40% |
$3.00 - $5.50 |
| Lamotrigine (Lamictal) |
Broad spectrum epilepsy |
25% |
$4.50 - $8.00 |
| Topiramate (Topamax) |
Partial and generalized seizures |
15% |
$2.00 - $4.50 |
| Briviact |
Partial seizures (adjunctive) |
10% |
$9.00 - $14.00 |
Pricing Dynamics
- Briviact is priced higher compared to older agents due to patent protection and branded positioning.
- The wholesale acquisition cost (WAC) averages $10.00 per pill for 50 mg strength.
- Patent expiration is expected in 2027, with some formulations potentially facing biosimilar competition afterward.
Market Trends
- Increasing adoption linked to expanding indications and improved tolerability.
- The rise in epilepsy prevalence among aging populations supports sustained demand.
- Generic competition anticipated post-2027 could reduce prices by 30-50%.
Price Projections
Short-Term (Next 3 Years)
- With patent exclusivity, prices are expected to stabilize near current levels.
- Marginal increases (~2-3%) driven by production costs and inflation.
- Peak annual sales projections: $600 million by 2025.
Mid to Long-Term (3-10 Years)
- Patent expiry around 2027 likely triggers significant price reductions.
- Entry of biosimilars could halve drug prices.
- Market share may shift from branded to generic competitors, reducing average price per unit to approximately $4.00-$6.00.
Price Forecast Summary
| Year | Expected Price Range (per pill) | Key Factors |
|-------|--------------------------------?|------------------------------------------|
| 2023 | $9.50 - $12.00 | Patent protection maintained |
| 2025 | $9.50 - $12.00 | Limited generic competition |
| 2028 | $4.00 - $6.00 | Patent expiration, biosimilar entry |
| 2030+ | $3.50 - $5.00 | Market saturation with generics |
Regulatory and Patent Considerations
- Patent protections extend to 2027, including formulation and method patents.
- Biosimilar competition expected after patent expiry, aligning with FDA biosimilar policies.
Summary of Key Data
- Current U.S. sales: Near $485 million (2022).
- Market share: Briviact holds ~10% in the epilepsy treatment segment.
- Patent expiration: 2027.
- Estimated price decline: 30-50% post-patent expiration.
- Long-term sales growth driven by aging populations and broader indications.
Key Takeaways
- Briviact is a branded, higher-cost epilepsy drug with growth potential until patent expiry in 2027.
- Market share is expected to decline post-patent, replaced by generics and biosimilars.
- Prices are forecasted to drop sharply after 2027, with mid-term stabilization.
- Competition from older agents like Keppra and Lamictal remains strong, limiting price escalation.
- The future market depends heavily on regulatory decisions regarding biosimilar approvals and patent enforcement.
FAQs
Q1: When does the patent for Briviact expire?
A1: Patent protection is expected to expire in 2027.
Q2: What factors could influence the post-2027 price trajectory?
A2: Introduction of biosimilars, generic competition, regulatory changes, and market uptake.
Q3: How does Briviact compare in efficacy to older agents?
A3: Briviact offers similar efficacy with a potentially better tolerability profile, which drives its premium pricing.
Q4: What are the key competitors for Briviact?
A4: Keppra (Levetiracetam), Lamictal (Lamotrigine), and Topamax (Topiramate).
Q5: Is there potential for new indications to support higher prices?
A5: Yes; expanding indications could sustain higher prices until patent expiry.
References
[1] IQVIA. (2023). U.S. Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2022). FDA Drug Label for Briviact.
[3] EvaluatePharma. (2022). 2022 Global Epilepsy Market Report.
[4] FDA. (2021). Biosimilar and Interchangeable Products Policies.
[5] S&P Capital IQ. (2022). Pharmaceutical Pricing and Market Trends Data.
