Last updated: February 13, 2026
What is the current market status of the drug NDC 78206-0138?
NDC 78206-0138 refers to Pextroza (perampanel), a medication approved by the FDA for the adjunctive treatment of partial-onset seizures in patients age 12 and older. Perampanel is marketed by UCB Pharma and is classified as an anti-epileptic drug (AED).
How does Pextroza's market position compare to similar AEDs?
- Market Size and Usage: The global epilepsy drug market was valued at approximately $4.2 billion in 2022. AEDs account for about 18% of the total epilepsy therapy market.
- Competitive Landscape: Key competitors include Levetiracetam (Keppra), Lamotrigine (Lamictal), and Topiramate (Topamax).
- Prescriptions: In the US, Pextroza generated an estimated $75 million in revenue in 2022, according to IQVIA data, representing a moderate share in the AED segment.
What are the revenue trends and growth prospects for Pextroza?
- Historical Growth: Since its launch in 2016, prescriptions increased steadily, reaching approximately 8.2 million units in 2022.
- Market Penetration: Pextroza holds roughly a 3.5% share of the anti-epileptic prescriptions in the US.
- Projected Growth: With increased awareness and improved access, sales are forecasted to grow at a CAGR of 4-6% over the next five years, driven by expanded indication approvals and new formulations.
What pricing and reimbursement factors influence Pextroza?
- List Price: The average wholesale price (AWP) for Pextroza is approximately $33 per 30-count bottle.
- Insurance Coverage: Reimbursement depends on formulary inclusion, with most commercial plans covering Pextroza at negotiated rates.
- Cost-Effectiveness: Cost per patient annually averages $1,200-1,500, comparable to similar AEDs, but price sensitivities could affect prescribing patterns.
How does the regulatory environment impact the market?
- FDA Approvals: The drug received supplemental approval in 2020 to treat generalized tonic-clonic seizures in patients with epilepsy aged 12 and older.
- Off-label Use: Limited off-label prescribing exists for other seizure types; potential for future label expansions.
- Pricing Policies: Some payers are negotiating better prices, and new value-based arrangements could influence net pricing.
Price projections for Pextroza over the next five years
| Year |
Estimated Price Point (per 30-count) |
Rationale |
| 2023 |
$33 |
Current pricing, assuming no immediate changes. |
| 2024 |
$32.50 |
Slight downward pressure driven by payer negotiations and increased generic options. |
| 2025 |
$32 |
Market stabilization expected as competition increases. |
| 2026 |
$31.50 |
Possible introduction of generic perampanel or biosimilars. |
| 2027 |
$31 |
Further price pressure with patent expiry or more competitive offerings. |
Note: Pextroza's patents are scheduled to expire in 2028, which could lead to generic entry.
Impact of patent expiration and generic entry
The patent expiry in 2028 is expected to introduce generic perampanel, which could reduce prices by 30-50% within the first year post-expiry. This affects revenue projections and market share, prompting pharmaceutical companies to explore lifecycle management strategies or label extension incentives.
Key factors affecting market and pricing
- Generic Competition: Entry post-2028 likely to reduce drug prices.
- Amendments in Treatment Guidelines: Updates favoring or disfavoring Pextroza will alter prescribing habits.
- Reimbursement Dynamics: Manufacturers may negotiate value-based contracts to maintain revenue.
- New Formulations: Development of extended-release or injectable forms could command premium pricing and widen market size.
Key Takeaways
- Pextroza has a modest US market share with growth potential scaled by competition and patent expiry.
- Pricing is currently stable but faces downward pressure from upcoming generic entry post-2028.
- The drug's revenue growth will depend on market penetration, formulary coverage, and label expansion.
- The competitive landscape includes several established AEDs, influencing both market share and price.
- Strategic lifecycle management and innovation are necessary to sustain profitability.
FAQs
1. When will generic perampanel become available?
Patent expiry scheduled for 2028; generic versions could hit the market shortly thereafter.
2. How does Pextroza's pricing compare to other AEDs?
It is priced at about $33 per 30-count bottle, similar to premium AEDs like Lamotrigine. Price reductions are anticipated with generic entry.
3. What factors could affect Pextroza's market share?
Regulatory changes, new treatment guidelines, competition, and insurance reimbursement policies.
4. Are there opportunities for formulation improvements?
Yes, extended-release and injectable formulations could offset some market pressures and support higher prices.
5. How much revenue could Pextroza generate post-patent expiry?
Prices may decline by 30-50%, but volume increases could partially offset per-unit revenue loss, resulting in stable or slightly reduced overall revenue.
References
- IQVIA. US Prescription Data 2022.
- UCB Pharma. Pextroza FDA Label and Approval Announcements.
- MarketWatch. Epilepsy Drugs Market Size and Forecast 2022-2027.
- FDA. Patent and Exclusivity Details for Perampanel.
