Last updated: February 27, 2026
What is NDC 46122-0650?
NDC 46122-0650 corresponds to a specific formulation of a pharmaceutical product. Based on available data, it is identified as Vigabatrin, a prescription medication used mainly for treating infantile spasms and refractory epilepsy. The drug is marketed under the brand name Sabril by Direct Relief and other manufacturers, with a primary focus on neurological conditions.
Market Size and Demand
Patient Population
- Infantile Spasms: Approximately 1,500–2,500 new cases annually in the U.S.
- Refractory Epilepsy: Estimated prevalence of 4 million cases in the U.S., with 15%-20% resistant to first-line treatments.
Market Penetration
- The drug typically accounts for a smaller segment of the epilepsy market.
- Usage is primarily in pediatric neurology centers and specialized neurological practices.
- The demand for Vigabatrin is driven by its unique indication for infantile spasms (FDA-approved) and off-label use in other refractory cases.
Competitive Landscape
- Other Treatments: ACTH, corticosteroids, and other antiepileptic drugs.
- Market Share: Vigabatrin holds approximately 10-15% of the niche market for infantile spasms, with growth potential tied to increased diagnosis and treatment adoption.
Pricing Landscape
Historical Pricing
- Average Wholesale Price (AWP): Approximately $3,000–$4,500 per 100 mg vial.
- Average Retail Price: Typical cash prices range from $6,000 to over $8,000 for a 30-day supply, varying by pharmacy and location.
Reimbursement Dynamics
- Medicare/Medicaid and private insurers typically reimburse at negotiated rates, often below AWP.
- Patient Out-of-Pocket Expenses: Can be significant, especially for uninsured or underinsured patients, affecting demand patterns.
Cost-Related Factors
- Manufacturing costs are relatively stable but subject to change based on raw material prices.
- Patent status influences generic availability, affecting prices.
Price Projections
Short-Term (1-2 years)
- Prices are likely to stabilize with minimal fluctuation if the patent status remains unchanged.
- Any patent expiration could trigger generic entry, causing prices to decline by 30-50%.
Medium to Long-Term (3-5 years and beyond)
- With patent expiration, generic versions may enter the market.
- Generic competition could reduce prices by up to 70% in the longer term.
- If new formulations or indications are approved, pricing could see increases up to 25%.
Future Market Dynamics
- Accelerated adoption for new indications could increase volume, but price reduction from generics will offset revenue gains.
- Policy changes, such as price regulation or increased emphasis on biosimilars, could directly influence pricing.
Potential Impact of Regulatory and Market Changes
| Factor |
Effect on Price |
| Patent expiration (expected within 3–5 years) |
Price decline expected; generic entry probable |
| New indications approved |
Possible price increase or premium for innovation |
| Changes in reimbursement policies |
Affects net revenue for manufacturers |
| Market entry of biosimilars or generics |
Drives prices downward |
Summary of Key Data
| Metric |
Value |
| Current market size (U.S.) |
$60–$90 million (estimated) |
| Annual demand (patients) |
1,500–2,500 cases |
| Current wholesale price |
$3,000–$4,500 per vial |
| Typical patient annual cost |
$6,000–$8,000 |
| Estimated price change post-generic |
Up to 70% reduction |
Key Takeaways
- NDC 46122-0650 (Vigabatrin) operates in a niche epilepsy market, with demand driven by infantile spasms and refractory epilepsy.
- Current pricing remains high, but generic competition is imminent, likely causing substantial price declines within 3-5 years.
- Market size is modest but stable, with potential revenue growth tied to new indications or formulations.
- Market dynamics are highly sensitive to patent status, regulatory decisions, and reimbursement policies.
FAQs
1. When is patent expiration expected for Vigabatrin?
Patent protection typically lasts about 10 years from approval; the original patent expired or will expire within 3–5 years, opening the market to generics.
2. How does generic entry affect market prices?
Generic entry generally reduces prices by 30–70%, depending on competition and manufacturing costs.
3. Are there alternative treatments for infantile spasms?
Yes, ACTH, corticosteroids, and other antiepileptic medications are alternatives, with varying efficacy and side effect profiles.
4. How does reimbursement influence drug pricing?
Reimbursement rates negotiated with payers directly impact net revenue, often keeping market prices below AWP.
5. What future market opportunities exist for Vigabatrin?
Potential exists with new indications, combination therapies, or formulation enhancements, but price pressure from generics remains a key factor.
Citations
[1] FDA. (2022). Sabril (Vigabatrin) Drug Label. U.S. Food and Drug Administration.
[2] IQVIA. (2022). U.S. Prescription Drug Market Trends.
[3] Medicare/Medicaid Reimbursement Data. (2023). Centers for Medicare & Medicaid Services.
[4] MarketResearch.com. (2022). Epilepsy and Seizure Disorder Drug Market Report.
