Last updated: February 22, 2026
What Is the Drug Product and Its Market Context?
NDC 00143-1174 corresponds to Brivaracetam, a prescription medication indicated for the treatment of partial-onset seizures in epilepsy. It is marketed under the brand name Briviact, primarily by UCB. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2016.
The drug competes mainly with other antiepileptic drugs (AEDs), such as levetiracetam (Keppra), lacosamide (Vimpat), and topiramate (Topamax). The global epilepsy therapeutic market valuation was approximately USD 4.5 billion in 2021, expected to grow at a compound annual growth rate (CAGR) of 5 percent through 2028 (MarketResearch.com, 2022).
Market Size and Revenue Potential
Current Market Position
- UCB's Briviact has achieved a significant share within the AED class due to its favorable safety profile.
- U.S. sales for Briviact reached approximately USD 400 million in 2022, representing steady growth from USD 320 million in 2021 (IQVIA, 2023).
Key Competitors
| Drug |
Market Share (2022) |
U.S. Sales (2022) |
Indications |
| Briviact |
~28% |
USD 400 million |
Partial-onset seizures |
| Keppra |
~35% |
USD 1.2 billion |
Partial seizures, generalized seizures |
| Vimpat |
~10% |
USD 350 million |
Partial seizures |
| Topamax |
~8% |
USD 280 million |
Multiple seizure types, migraine |
Future Market Growth Drivers
- Increasing epilepsy prevalence, estimated at 3.4 million U.S. adults (CDC, 2021).
- Rising off-label use and expanding indications, including pediatric epilepsy.
- Patient preference for drugs with improved side effect profiles and less drug-drug interaction.
Price Trends and Projections
Current Pricing Landscape
- Wholesale acquisition cost (WAC) for Briviact in the U.S. is roughly USD 30 per capsule.
- The typical dosage regimen involves 50-150 mg twice daily, leading to monthly treatment costs of USD 1,800–USD 5,400.
- Out-of-pocket costs for patients depend on insurance coverage and copay assistance programs but remain substantial.
Price Dynamics (2021-2023)
| Year |
Approximate WAC per Capsule |
Monthly Cost at Standard Dose |
Notes |
| 2021 |
USD 25 |
USD 1,500 |
Price baseline before market expansion increases |
| 2022 |
USD 30 |
USD 1,800 |
Market penetration and inflation effects |
| 2023 |
USD 30–32 |
USD 1,800–USD 1,920 |
Slight adjustments, potential for discounts |
Forecasted Price Trends (2024-2028)
- Prices are expected to stabilize or slightly decline (1-2%) due to increased competition and formulary negotiations.
- The introduction of biosimilars or generics (if applicable) could accelerate downward price pressure.
- Pricing strategies might include discounts, patient assistance programs, or dosage optimization.
Regulatory and Policy Influences on Pricing
- The U.S. Food and Drug Administration (FDA) approval of patent extensions or exclusivity can sustain high prices.
- The 340B Drug Pricing Program and Medicaid rebate policies influence net prices.
- The Inflation Reduction Act (2022) may impact drug pricing transparency and negotiating power.
Investment and Business Implications
- Companies may pursue lifecycle management, including new formulations or indications, to justify price stability.
- Payer negotiations and formulary placements are critical to maintaining revenue streams.
- Market entry of generic competitors could reduce prices by up to 50% within 3-5 years of patent expiry.
Key Takeaways
- NDC 00143-1174 (Briviact) occupies a significant position in the epilepsy drug market, with U.S. sales of USD 400 million in 2022.
- The overall epilepsy therapeutics market is projected to grow at a CAGR of 5%, driven by rising prevalence and expanding indications.
- Current U.S. prices for Briviact hover around USD 30 per capsule, with modest upward adjustments expected through 2023.
- Price competition and biosimilar/generic entry are primary factors that could reduce prices over the next 3-5 years.
- Market revenue growth depends heavily on evolving clinical guidelines, formulary access, and payer negotiations.
FAQs
1. How does the patent status impact the future price of NDC 00143-1174?
Patent expiration, expected around 2025, may open the market to generics or biosimilars that generally lead to significant price reductions.
2. What are the primary factors influencing Briviact’s pricing strategy?
Market competition, clinical efficacy, insurance reimbursement policies, and patent status are key factors.
3. How do off-label uses affect the drug’s market value?
Off-label uses expand market size, potentially sustaining higher prices and sales volume.
4. What can stakeholders expect regarding future regulatory impacts?
Policy reforms, including drug pricing transparency initiatives, could influence negotiated prices and access.
5. Are generic versions of Briviact expected soon?
Generic entry may occur within 1-2 years of patent expiry, expected around 2025, likely causing significant price decreases.
References
[1] MarketResearch.com. (2022). Global Epilepsy Therapeutics Market Report.
[2] IQVIA. (2023). U.S. Prescription Drug Sales Data.
[3] Centers for Disease Control and Prevention (CDC). (2021). Epilepsy Data.
