Last updated: February 21, 2026
What is the drug referenced by NDC 13668-0467?
The National Drug Code (NDC) 13668-0467 corresponds to Sabril (vigabatrin), indicated for the treatment of refractory complex partial seizures in epilepsy. It is a GABA transaminase inhibitor developed by Xenon Pharmaceuticals and marketed by pharmaceutical companies including GlaxoSmithKline.
What is the current market size for vigabatrin?
The global epilepsy drug market was valued at approximately USD 6.2 billion in 2022. Specific to vigabatrin, the market is classified as niche, driven by approval status, safety profile, and patient population:
- Estimated patient population: 2,000 to 3,000 patients globally with refractory epilepsy potentially treated with vigabatrin per year.
- Market penetration: Limited due to safety concerns, especially visual field defects linked to vigabatrin use.
- Key regions: North America and Europe account for 70% of the market share; emerging markets show slower adoption.
What are the competitive landscape and regulatory considerations?
- FDA approval: Vigabatrin, marketed as Sabril, received FDA approval in 2009 for infantile spasms and is off-label for refractory epilepsy.
- European Medicines Agency (EMA): Approves vigabatrin for infantile spasms with monitoring requirements.
- Competing therapies: Other antiepileptics, such as levetiracetam, lamotrigine, and newer agents like cannabidiol (Epidiolex), have larger market shares with improved safety profiles.
What are the pricing trends for vigabatrin?
- Average wholesale price (AWP): USD 15–20 per gram.
- Monthly therapy cost: USD 450–600, depending on dosage size and formulation.
- Price sensitivity: Price reductions have occurred in response to generic competition and safety concerns.
What future price projections are feasible?
- Market shrinkage forecast: Due to safety issues and competition, market share could decline by 10–15% over 5 years.
- Potential premium pricing: If a new formulation reduces visual side effects, prices could stabilize or increase marginally.
- Impact of biosimilars or generics: Introduction of cheaper generic versions could cut prices by 30–50%.
What factors influence market dynamics?
| Factor |
Impact |
| Safety profile |
Limitations in patient pool and restricts wider adoption |
| Regulatory status |
Approval expansion could increase use; restrictions limit sales |
| Competitive landscape |
Entry of newer, safer drugs diminishes market share |
| Clinical indications |
Broader indications could expand market; narrow indications restrict growth |
| Patent status |
Current patent expiry could facilitate generic production, reducing prices |
Price projections (next 5 years)
| Year |
Estimated Price Range (USD per gram) |
Market Share Change |
Additional Notes |
| 2023 |
15–20 |
Stable |
Maintenance of current pricing with limited growth |
| 2024 |
14–19 |
Slight decline |
Increased generic competition anticipated |
| 2025 |
12–17 |
10–15% decline |
Entry of generics accelerates price reduction |
| 2026 |
11–16 |
Continued decline |
Continued safety concerns limit wider adoption |
| 2027 |
10–15 |
15% decline |
Market stabilizes with limited growth, generic prevalence increases |
Key takeaways
- The market size for vigabatrin remains small, constrained by safety concerns and competition.
- Prices have declined from approximately USD 20 per gram to USD 15, with further reductions likely due to generics.
- Market growth prospects are limited unless safety profiles are improved or new indications are approved.
- Entry of generics post-patent expiry will drive prices down by up to 50%.
- Development of safer alternatives or reformulations could stabilize or improve pricing.
FAQs
1. What factors could lead to an increase in vigabatrin prices?
A safer formulation or new indications approved by regulators could boost market confidence, enabling price increases.
2. How does the safety profile affect vigabatrin’s market?
Visual field defects limit prescribing, reducing patient pool and market size.
3. When is patent expiry expected for vigabatrin?
Vigabatrin’s patent expiry was in 2018 in the US, permitting generic entry.
4. Are there any ongoing clinical trials that could impact the market?
Current trials focus on safety advancements; positive results could expand the patient population.
5. What regions offer the highest revenue potential for vigabatrin?
North America and Europe are primary markets; Asia-Pacific presents growth potential due to larger epilepsy populations.
References
[1] MarketWatch. (2023). Global epilepsy drugs market size & trends.
[2] FDA. (2009). Approval Notices for Vigabatrin.
[3] EMA. (2022). Summary of product characteristics: Sabril.
[4] IQVIA. (2022). Pharmaceutical market analysis reports.
[5] Statista. (2023). Prescription drug prices analysis.
