Last updated: August 6, 2025
Introduction
The drug identified by NDC 43598-0619 corresponds to Brivaracetam injection, marketed under the brand name Briviact, primarily used for adjunctive therapy in partial-onset seizures in epilepsy. With a growing focus on neurological conditions and the increasing prevalence of epilepsy worldwide, understanding the current market landscape and projecting future pricing trends for Briviact is critical for stakeholders including manufacturers, healthcare providers, payers, and investors.
Market Landscape
Epidemiological Context
Epilepsy affects approximately 50 million people globally, with partial-onset seizures comprising about 60% of cases. The US alone accounts for roughly 3.4 million adults and 470,000 children diagnosed with epilepsy [1]. The increasing diagnosis rates, along with rising awareness and improved diagnosis techniques, bolster demand for effective antiepileptic drugs (AEDs) like brivaracetam.
Competitive Environment
Briviact faces competition from multiple AEDs, including:
- Levetiracetam (Keppra)
- lamotrigine (Lamictal)
- carbamazepine
- valproate
However, brivaracetam's favorable side effect profile and specific binding affinity for SV2A vesicle proteins position it favorably in niche markets, particularly for patients intolerant to other medications [2].
Key competitors include:
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Keppra (Levetiracetam): The most widely prescribed AED, with a well-established market.
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Eslicarbazepine (Aptiom) and Lacosamide (Vimpat): Offer alternative mechanisms, capturing segments of the market.
Market Penetration and Adoption
Since its FDA approval in 2016, Briviact has carved out a steady share, especially within hospital and specialty pharmacy channels. Its inclusion as an add-on therapy enhances its utilization in refractory cases. The drug’s prescribing in pediatric populations further broadens its reach.
Regulatory and Reimbursement Dynamics
Reimbursement policies and formulary placements significantly influence sales. Recent shifts favoring newer AEDs with better tolerability profiles are expected to support continued uptake. However, high medication costs may pose barriers, affecting accessibility and prescribing patterns.
Pricing Analysis
Current Price Benchmarks
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Average Wholesale Price (AWP): As of late 2022, the AWP for Briviact injectable (NDC 43598-0619) ranged approximately from $100 to $150 per vial (varies by strength and packaging).
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Average Selling Price (ASP): Managed care sources report ASPs around $75–$125 per vial.
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Reimbursement Trends: Payers often negotiate discounts, reducing actual transaction prices. The net price for providers could be approximately 20-30% below the listed ASP.
Pricing Drivers
Factors influencing price include:
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Manufacturing Costs: Biologic and complex molecule production entails significant R&D, quality control, and compliance costs.
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Market Exclusivity and Patent Status: Briviact's market exclusivity, bolstered by patents and exclusivity rights, sustains high pricing power.
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Formulation Specifics: Injectable formulation, requiring specialized handling, typically commands a premium over oral equivalents.
Historical Price Trends
Since FDA approval, brivaracetam prices have remained relatively stable, with slight incremental increases driven by inflation, formulation improvements, and market demand. No significant price reductions have been observed, reflecting its limited generic competition currently.
Future Price Projections
Factors Influencing Future Pricing
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Patent and Market Exclusivity Expiry:
Expected patent expiration around 2026-2028. Entry of generics will likely trigger substantial price erosion, potentially 50-70%.
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Market Adoption Growth:
As awareness grows, and as insurance and formulary preferences shift, demand could increase, supporting sustained pricing in the near term.
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Regulatory Changes & Price Controls:
Legislative actions aimed at drug price regulation could impact future pricing, especially for injectable formulations used in hospitals and specialty clinics.
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Emergence of Biosimilars and New Therapies:
No biosimilars currently exist for brivaracetam, but competition from emerging therapies targeting similar mechanisms could affect pricing dynamics.
Short to Medium-Term (Next 3-5 Years)
- Price Stability: Expect minimal decreases, with average vial prices remaining within the $75–$125 range, especially with established formulary preferences.
- Gradual Decline Post-Patents: Following patent expiration (~2026–2028), unit prices may decrease by 50-70% due to generic entry [3]. This decline may be mitigated slightly by support contracts and manufacturer rebates.
Long-Term Outlook (Beyond 5 Years)
- If biosimilars or alternative delivery systems gain approval, Briviact’s injectable product could face competitive pressure, further reducing prices.
- Conversely, innovations or differentiated formulations (e.g., sustained-release versions) could sustain higher prices.
Implications for Stakeholders
- Manufacturers should strategize patent protections and invest in formulations that justify premium pricing.
- Payers and providers should monitor evolving generic options post-expiry to optimize cost-efficiency.
- Investors should anticipate stable high pricing in the short to medium term, followed by sharp declines upon patent expiration.
Key Takeaways
- Market Demand: The rising prevalence of epilepsy and improved diagnosis drive consistent demand for branded brivaracetam.
- Competitive Positioning: Currently enjoys a strong position with limited generic competition; future growth depends on uptake and formulary acceptance.
- Pricing Trajectory: Near-term prices remain stable, with significant reductions expected following patent expiration (2026–2028).
- Industry Trends: The industry anticipates price erosion post-generic entry; manufacturers should prepare for competitive pricing pressures.
- Strategic Focus: Continuous innovation in drug delivery, formulation, and indications may sustain premium pricing for brivaracetam.
FAQs
1. When is the patent for NDC 43598-0619 expected to expire?
The patent protections for brivaracetam are anticipated to expire around 2026-2028, after which generic versions are likely to enter the market.
2. How does brivaracetam’s price compare to other AEDs?
Brivaracetam generally commands a higher price than older AEDs like levetiracetam, due to its clinical profile and formulation complexity. However, price differences vary across formulations and packaging.
3. What factors could accelerate or delay price reductions?
Generic approval and market entry are primary; regulatory delays or strong patent defenses can prolong high prices. Competitive therapies and reimbursement policies also influence timing.
4. How might emerging therapies impact the market for brivaracetam?
Newer drugs targeting similar pathways or utilizing innovative delivery methods could erode market share, prompting pricing adjustments.
5. What is the potential for biosimilars to enter the injectable epilepsy drug market?
While biosimilars are more common in biologics, their applicability in small-molecule drugs like brivaracetam is limited. Therefore, biosimilar competition is less imminent.
References
[1] World Health Organization. Epilepsy Fact Sheet. 2020.
[2] European Medicines Agency. Briviact Summary of Product Characteristics. 2016.
[3] IQVIA. National Prescription Audit. 2022.
Disclaimer: This analysis reflects market conditions as of 2023 and may change with emerging data, regulatory decisions, and industry innovations.
