Last updated: February 20, 2026
What is NDC 51407-0610?
NDC 51407-0610 refers to the drug Vigabatrin (Sabril), an antiepileptic medication used to treat infantile spasms and complex partial seizures. The drug is marketed primarily by Lundbeck and has received indications coverage from the FDA since 2009.
Market Size and Key Drivers
Global and U.S. Market Scope
- The global anti-epileptic drug (AED) market was valued at approximately USD 4.5 billion in 2021.
- The U.S. accounts for over 40% of the global market, with an approximate market size of USD 1.8 billion in 2021.
- The demand for Vigabatrin remains focused on niche populations such as infantile spasms and drug-resistant epilepsy.
Patient Population and Usage
- Estimated prevalence of infantile spasms in the U.S.: 1 in 2,000 to 3,000 live births.
- Roughly 20-25% of epilepsy cases are resistant to first-line treatment, making Vigabatrin a second- or third-line therapy.
- Market penetration is limited by safety profiles, particularly potential vision loss.
Competitive Landscape
| Drug Name |
Approval Year |
Indications |
Market Share (Estimated) |
Price Range (USD per 500 mg) |
| Vigabatrin (Sabril) |
2009 |
Infantile spasms, refractory seizure |
60% |
USD 150 - USD 250 |
| Topiramate |
1996 |
Partial and generalized seizures |
20% |
USD 60 - USD 120 |
| Levetiracetam |
2000 |
Multiple seizure types |
10% |
USD 130 - USD 210 |
Regulatory and Reimbursement Environment
- Under the U.S. Medicaid and commercial insurance, reimbursement remains available but has constraints due to concerns over adverse effects.
- Off-label use is common but limited by safety reports.
Price Projections for NDC 51407-0610
Historical Pricing Trends
- The average wholesale price (AWP) for Vigabatrin has ranged from USD 120 to USD 250 per 500 mg tablet since 2015.
- Discounted prices, under pharmacy benefit managers (PBMs), typically range 15-25% below AWP.
Short-Term Projections (Next 2 Years)
- Prices are predicted to stabilize, with minor inflation-driven increases (2-3% annually).
- Market penetration will have limited impact on pricing due to safety concerns, with generics unlikely to significantly diminish pricing margins.
- New formulations or delivery methods (e.g., liquid versions) could influence prices by +5-10% if approved.
Long-Term Outlook (3-5 Years)
- Entry of biosimilars or alternative therapies targeting infantile spasms could reduce price by 10-20% through generic competition.
- Patent exclusivity expiration is not applicable; however, safety concerns and prescribing restrictions mitigate aggressive price cuts.
- Overall, the price per tablet is expected to maintain USD 150 - USD 200, reflecting current market dynamics.
Key Factors Affecting Pricing
- Safety concerns, especially retinal toxicity, restrict broad prescribing.
- Limited approved indications prevent commoditization.
- Market size constrains significant volume growth, maintaining high per-unit prices.
Conclusion
Vigabatrin (NDC 51407-0610) maintains a niche position in the epilepsy treatment market. Its pricing remains stable with slight upward pressure over the next two years, with long-term reductions limited by safety issues and limited generic competition. The drug's market opportunity hinges on continued approval for specific indications and potential safety improvements.
Key Takeaways
- The U.S. market for Vigabatrin is valued at roughly USD 100 million annually.
- Current prices hover around USD 150 to USD 250 per 500 mg tablet.
- Market growth is constrained by safety concerns and limited indications.
- Short-term prices are unlikely to decline significantly; long-term prices may decrease 10-20% with generics.
- Competition from newer therapies and biosimilars will influence future pricing trends.
FAQs
1. What factors most influence Vigabatrin pricing?
Safety profile concerns, limited indications, and patent exclusivity drive pricing stability. Safety issues restrict broad use, maintaining high per-unit costs.
2. How does the safety profile affect market penetration?
Potential retinal toxicity reduces prescribing frequency, limiting total volume despite high demand in specific populations.
3. Are generics available for NDC 51407-0610?
Currently, no authorized generics exist, but market entry of biosimilars or generics could reduce prices 10-20% over five years.
4. What are the main competitors to Vigabatrin?
Topiramate and levetiracetam account for larger market shares due to broader approved uses, but Vigabatrin remains relevant for specific refractory cases.
5. How might regulatory changes impact prices?
If safety concerns lead to restrictions or new formulations improve safety profiles, prices could stabilize or increase temporarily. Conversely, expanded indications or approvals for alternative therapies might pressure prices downward.
Sources:
[1] MarketWatch. (2022). Anti-epileptic drug market size and trends.
[2] FDA. (2022). Drug approval history and indications for Vigabatrin.
[3] IMS Health. (2021). Prescription drug pricing database.
[4] IQVIA. (2022). U.S. prescription drug market share analysis.
[5] ClinicalTrials.gov. (2022). Safety and efficacy studies on Vigabatrin.
Note: All data are estimates based on current market reports; actual prices and market share may vary.
