Last updated: April 2, 2026
What Is NDC 68001-0690?
NDC 68001-0690 refers to a specific pharmaceutical product registered under the National Drug Code (NDC). This code corresponds to a targeted formulation, dosage, and packaging of a drug. Based on available data, this NDC is associated with Brivaracetam (marketed as Briviact) in various strengths and formulations.
Market Overview
The market for Brivaracetam primarily covers patients with epilepsy, specifically partial-onset seizures, where it is used as an adjunctive therapy.
Key Market Drivers
- Rising incidence of epilepsy globally, with approximately 50 million affected individuals.
- Increased adoption of adjunctive therapies for partial-onset seizures.
- Label expansions and additional formulations broadening patient access.
- Competitive landscape with generics and biosimilars entering to reduce costs.
Market Size
- Global epilepsy treatment market valued at $4.0 billion in 2022.
- Expected Compound Annual Growth Rate (CAGR): 5.2% from 2023 to 2030.
- U.S. market accounts for roughly 50% of this market.
Competitive Landscape
- Briviact (UCB Pharma) holds significant market share.
- Generic versions appearing post-patent expiry, accelerating price competition.
- Key competitors include levetiracetam, lamotrigine, and other novel anti-epileptic drugs.
Patent Status
- Brivaracetam’s patent protections in the U.S. extended into 2027.
- Patent cliff imminent in 2027, likely to trigger increased generic competition.
Price Projections
Current Pricing Benchmarks
- Brand-name Briviact (NDC 68001-0690): Approximately $550 per 30-day supply for typical adult dosages (e.g., 50 mg twice daily).
- Generic versions (post-patent expiry): Prices range from $250 to $400 for similar pack sizes.
Historical Pricing Trends
- Prices peaked in 2020 at around $600 per month.
- Post-2021, prices declined with the entry of generics.
- As of 2023, average costs for similar branded products hover around $550.
Price Forecast (Next 5 Years)
| Year |
Brand Price per 30-day supply |
Generic Price per 30-day supply |
| 2023 |
$550 |
$300 |
| 2024 |
$530 |
$280 |
| 2025 |
$510 |
$260 |
| 2026 |
$490 |
$250 |
| 2027 |
$480 |
$240 |
Post-2027, with patent expiration fully realized and biosimilar entry, prices could fall further, approaching $150–$200 per month for generics.
Regulatory Influence
- The FDA approved the original brand in 2016.
- Patent protections extended to 2027, with exclusivity periods running through 2026.
- FDA approval of generic versions is anticipated to begin around 2028, contingent on patent litigation and bioequivalence approvals.
Market Entry and Pricing Impact
- Generic entry expected to reduce monthly prices by 40%–50% within the first year.
- Biosimilar options, if authorized, could further lower prices.
- Payers and pharmacy benefit managers may negotiate discounts, further impacting net prices.
Risks Affecting Price Stability
- Slower-than-expected generic uptake due to prescriber or patient brand loyalty.
- Delays in biosimilar or generic approvals.
- Changes in epilepsy prevalence or shifting treatment paradigms with newer agents.
Strategic Considerations for Stakeholders
- Investors should monitor patent expiration timelines.
- Manufacturers may consider licensing or securing rights to biosimilar development.
- Payers might negotiate rebates and formulary placements to control costs.
Key Takeaways
- NDC 68001-0690 is associated with key epilepsy therapy Briviact.
- The U.S. market size is significant, with expected CAGR of 5.2%.
- Prices are projected to decline from approximately $550 in 2023 to under $250 by 2027.
- Patent expiry in 2027 will catalyze generics, further dropping prices.
- Regulatory and market entry delays can alter price trajectory.
FAQs
Q1: When will generic versions of NDC 68001-0690 become available?
A1: Expected around 2028, following patent expiration and FDA approval processes.
Q2: How much will prices likely decrease post-generic entry?
A2: Approximately 40%–50%, leading to prices near $150–$200 monthly.
Q3: What factors could delay generic or biosimilar market entry?
A3: Patent litigation, FDA bioequivalence approval delays, or market resistance.
Q4: Are there differentiation factors that could sustain higher prices?
A4: Limited, primarily driven by brand loyalty or formulation-specific benefits.
Q5: How does pricing compare internationally?
A5: U.S. prices are higher; European markets often see prices 20%–40% lower, influenced by healthcare policies.
References
[1] Market research reports, "Epilepsy Treatment Market," Grand View Research, 2022.
[2] FDA drug approval archives, 2016–2023.
[3] U.S. Department of Health and Human Services, "Patent and Exclusivity Data," 2023.
