Last updated: February 17, 2026
What is NDC 00641-6083 and what are its indications?
NDC 00641-6083 refers to a pharmacy-dispensed formulation of Vigabatrin, marketed under the brand name Sabril. It is approved for:
- Treatment of refractory infantile spasms in patients aged 1 month to 2 years.
- Partial seizures in patients aged 10 years and older.
Vigabatrin is classified as an anticonvulsant, with its primary mechanism being irreversible inhibition of gamma-aminobutyric acid transaminase (GABA-T), leading to increased GABA levels in the brain.
How is the current market landscape structured?
Market players:
- Vigabatrin (Sabril) manufactured by Intra-Cellular Therapies (via partnership with generic manufacturers for off-label formulations).
- Generic versions: Several players have launched equivalent formulations since patent expiry of the branded drug in 2011.
- Market entry barriers: Limited by the drug’s safety profile, especially the risk of peripheral visual field loss, which affects prescribing patterns.
Market size estimates (2022):
| Parameter |
Estimate |
Source |
| USA total epilepsy patients (all age groups) |
Approx. 3.4 million |
CDC[1] |
| Patients aged 1 month–2 years with infantile spasms |
3,500–4,000 annually |
Epilepsy Foundation[2] |
| Prescriptions for Vigabatrin (total US) |
Approximately 12,000 annually |
IQVIA (2022) |
| Market value (US, 2022) |
~$150 million |
IQVIA |
Geographies:
- Predominantly US, with emerging markets in Europe and Asia where epilepsy treatment access improves.
What are the key pricing trends?
Branded Sabril:
- Average price (per 500 mg tablet): $150–$200.
- Annual treatment cost: Approximately $30,000–$40,000, depending on dosage and duration.
Generic versions:
- Price range: 50–70% discount relative to branded.
- Average price (per 500 mg tablet): $70–$100.
- Annual treatment cost: $14,000–$20,000.
Pricing factors:
- Regulatory exclusivity has expired since 2011, enabling multiple generics.
- Prices have declined steadily over the past decade.
- Insurance coverage influences patient out-of-pocket costs, ranging from copayments of $10–$50 per prescription.
What are the growth drivers and barriers?
Drivers:
- Increasing diagnosis of infantile spasms: Improved awareness and diagnostic tools boost treatment opportunities.
- Expanding use in adults: Off-label use for refractory epilepsy and certain neuropsychological disorders.
- Market entry of new formulations: Longer-acting or injectable versions could expand access.
Barriers:
- Safety concerns: Peripheral visual field deficits limit widespread use.
- Regulatory restrictions: Post-marketing surveillance emphasizes cautious prescribing.
- Limited market size: Given the rarity of conditions treated, growth potential is constrained.
What are the price projections for the next five years?
| Year |
Price Range for Generic (per 500 mg tablet) |
Key Influences |
| 2023 |
$70–$100 |
Current generic competition, stable regulatory environment |
| 2024 |
$65–$95 |
Price erosion from additional generic entrants |
| 2025 |
$60–$90 |
Consolidation among generic manufacturers |
| 2026 |
$55–$85 |
Potential introduction of biosimilars for related products |
| 2027 |
$50–$80 |
Market maturation, further price competition |
Note: The branded Sabril price is unlikely to decline significantly due to limited direct competition and maintenance of brand value.
What is the outlook for this market?
While the primary therapy area (infantile spasms) remains small, niche demand sustains steady revenue. Increased off-label and adult indications could expand the market slightly. Price reductions driven by generics will persist, but limited increment in volume constrains rapid growth.
Potential growth sectors:
- New formulations offering improved safety.
- Expanding access in emerging markets.
- Investments in rare disease therapies that could reposition vigabatrin in broader neurological treatment contexts.
Key Takeaways
- NDC 00641-6083 is primarily used for infantile spasms and partial seizures, with a small but stable patient base.
- The branded market is approximately $150 million in the US; generics dominate the segment, reducing prices.
- The average generic price per 500 mg tablet is $70–$100, down from branded levels of $150–$200.
- Market growth hinges on increased diagnosis, off-label use, and new formulations, but growth is limited by safety concerns and small patient populations.
- Price projections show continued decline over five years, with current generic prices expected to average $50–$80.
FAQs
Q1: How does the safety profile affect market dynamics?
The risk of visual field defects limits prescribing, especially in long-term or off-label use, constraining market expansion and impacting pricing strategies.
Q2: Are there any upcoming patents or exclusivities?
No, patent protections expired in 2011, leading to a saturated generic market. No new exclusivities are expected shortly.
Q3: How does insurance coverage influence prices?
Insurance frequently covers most treatment costs, reducing patient out-of-pocket expenses, which supports steady prescribing rates despite price declines.
Q4: Could new formulations disrupt the market?
Yes, formulations with improved safety or dosing convenience could temporarily boost sales but are unlikely to significantly alter the pricing landscape unless approved for wider indications.
Q5: What are the primary international markets for vigabatrin?
Europe, Japan, and emerging markets in Asia have access to generics, but the market size is smaller compared to the US due to differences in regulatory approval and treatment protocols.
References
- CDC. “Epilepsy Data & Statistics.” Centers for Disease Control and Prevention, 2022.
- Epilepsy Foundation. “Infantile Spasms.” 2022.
