Last updated: February 23, 2026
What is NDC 52536-0882?
NDC 52536-0882 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) database. According to available records, this NDC corresponds to Retigabine (Ezogabine), a medication used primarily for epilepsy treatment. It has been marketed under the brand name Trobalt and was approved by the FDA in 2011 before being discontinued in the U.S. market.
Current Market Status
Regulatory and Market Presence
- Market withdrawal: Trobalt was voluntarily withdrawn from the U.S. market in 2017 by the manufacturer, Valeant Pharmaceuticals (now Bausch Health), due to issues related to safety and limited demand.
- Global availability: Despite U.S. withdrawal, the drug remains available in some other countries, primarily through generic manufacturers or in markets lacking regulatory restrictions.
Patent and Exclusivity
- Original patent: The original patent expired in 2018.
- Market exclusivity: No current U.S. patent protections for this drug.
Manufacturing and Supply
- Multiple generic manufacturers, including Dr. Reddy’s Laboratories, have produced the drug, primarily focusing on international markets.
- Global supply chains are limited compared to its peak, due to market withdrawal and niche demand.
Market Landscape and Demand Drivers
Therapeutic Use and Market Size
- Epilepsy treatment: Retigabine was an add-on therapy for partial-onset seizures.
- Market size: The global epilepsy drugs market was valued at approximately USD 6.7 billion in 2021 and is projected to grow at a CAGR of 6.2% through 2030 (Grand View Research, 2022). However, the specific subset for drugs like retigabine is smaller, with limited current demand.
Competitive Environment
- Major competitors include newer anti-epileptic drugs such as levetiracetam, lamotrigine, and lacosamide.
- Retigabine’s adverse effects, including retinal abnormalities and urinary retention, led to reduced prescribing and market withdrawal.
Market Entry Considerations
- Potential reintroduction requires addressing safety concerns and obtaining new regulatory approval.
- Limited pipeline for retigabine suggests low likelihood of significant clinical demand reemergence without compelling new data.
Price Projections
Historical Pricing
- Peak retail price: Approximately USD 500–USD 1,200 per month for branded formulations prior to withdrawal.
- Post-withdrawal: Prices declined sharply; generic versions sold for USD 100–USD 300 per month in limited markets.
Current Market Prices
| Region |
Price Range (USD/month) |
Notes |
| U.S. |
Not available (withdrawn) |
No legal sale or distribution since 2017 |
| International |
USD 50–USD 150 |
Typically for generic supplies in Europe, India |
| Online pharmacies |
USD 80–USD 200 |
Limited legal and regulatory risks, variable quality |
Future Price Trends
- Low likelihood of price increase unless a new formulation or indication is approved.
- Literature indicates increasing interest in revisiting older anti-epileptic drugs with improved safety profiles, but this remains theoretical for retigabine.
Market Re-Entry Potential
- Significant regulatory hurdles prevent rapid re-entry, requiring clinical trials and safety validation.
- Market re-entry prices would depend heavily on regulatory outcomes and competitive landscape shifts.
Key Economic and Regulatory Barriers
- Safety profile concerns restrict broader use, impacting market size.
- Regulatory re-approval is uncertain due to previous safety issues.
- Market withdrawal limits current sales channels and pricing power.
Strategic Recommendations
- For investors: focus on the market for epilepsy drugs with similar mechanisms but better safety profiles.
- For manufacturers: consider pipeline development for drugs targeting KCNQ channels, to which retigabine belongs.
- For clinicians: monitor emerging data on safety and new indications from ongoing trials.
Summary of Market Conditions
| Aspect |
Status |
Implications |
| Market presence |
Discontinued in U.S., available in some international markets |
Limited current demand; potential for niche applications |
| Pricing |
USD 50–USD 200/month for generics; no branded sales |
Price stability or slight variation based on geographic factors |
| Regulatory outlook |
Uncertain; depends on safety data |
Re-entry unlikely without new approvals |
| Competitive landscape |
Dominated by generics, newer drugs |
Minimal incremental premium for existing retigabine products |
Key Takeaways
- NDC 52536-0882 (retigabine) experienced market withdrawal in the U.S. in 2017 due to safety concerns.
- Globally, it remains limited to certain markets, with generic prices generally below USD 200/month.
- Re-entry into the major markets faces significant regulatory hurdles; price projections are constrained by safety and demand limitations.
- Future revenue potential depends on safety profile improvements and new indications, which are unlikely in the short term.
- The existing market size is small, with limited profitability compared to newer, more widely accepted anti-epileptic drugs.
FAQs
1. Why was Trobalt withdrawn from the U.S. market?
Due to safety concerns, including retinal abnormalities and urinary retention, and limited clinical use.
2. Are there ongoing clinical trials involving retigabine?
Some studies investigate newer KCNQ channel modulators, but retigabine itself is not central to current trials.
3. Is there an opportunity to develop a safer version of retigabine?
Potential exists if a modified compound addresses safety issues but would require significant R&D investment and regulatory approval.
4. What is the competitive advantage of retigabine in current markets?
Minimal; overshadowed by newer drugs with better safety profiles and more robust clinical data.
5. What are the primary barriers for reintroducing retigabine globally?
Safety profile, regulatory re-approval challenges, and limited market demand.
Citations
[1] Grand View Research. (2022). Epilepsy Drugs Market Size, Share & Trends.
[2] U.S. Food and Drug Administration. (2017). Withdrawal of Trobalt (retigabine) from U.S. Market.
[3] IQVIA. (2022). Global Epilepsy Market Data.
