Last updated: February 24, 2026
What is NDC 72495-0201?
NDC 72495-0201 is a drug identified under the National Drug Code (NDC) system. This code corresponds to Vigabatrin (brand name Sabril). Since its approval, Vigabatrin has been primarily used as an anticonvulsant medication indicated for treatment-resistant epilepsy and infantile spasms.
Product Details
| Attribute |
Details |
| NDC |
72495-0201 |
| Drug Name |
Vigabatrin (Sabril) |
| Formulation |
500 mg tablets |
| Route |
Oral |
| Approval Date |
2009 (FDA approval for epilepsy) |
| Manufacturer |
Teva Pharmaceuticals |
Current Market Dynamics
Market Size and Adoption
- Patient Population: Estimated 150,000–200,000 patients in the U.S. with treatment-resistant epilepsy or infantile spasms, where Vigabatrin is prescribed.
- Market Penetration: Prescribed mainly after failure of first-line antiepileptic drugs; access is limited by the risk of vision loss, leading to conservative prescribing practices.
- Reimbursement Landscape: Covered under Medicare and private insurance; copay varies but generally between $10–$50 per month, depending on insurance.
Competitive Landscape
- Direct Competitors: Other anti-epileptic drugs such as topiramate, valproate, and lamotrigine.
- Indirect Competitors: Newer medications and gene therapies in development.
- Market Share: Estimated to hold 5–8% of the niche anticonvulsant market due to safety concerns and limited formulary inclusion.
Regulatory Constraints
- Risk Evaluation & Mitigation Strategies (REMS): Mandatory REMS program for Vigabatrin due to risk of permanent vision loss, limiting prescription volume.
- Labeling Restrictions: Prescribed only by qualified specialists; patient monitoring protocols mandated.
Price Analysis (Historical & Current)
| Year |
Average Wholesale Price (AWP) |
Estimated Monthly Price |
Notes |
| 2018 |
$600 per 30-count bottle |
$20 per pill, $600/month |
Price reflects standard generics |
| 2020 |
$620 per 30-count bottle |
$20.67 per pill |
Slight increase due to supply chain factors |
| 2022 |
$650 per 30-count bottle |
$21.67 per pill |
Market stability, supply chain normalized |
| 2023 |
$660 per 30-count bottle |
$22 per pill |
Steady pricing trend |
Prices are adjusted for average wholesale costs; actual patient prices under insurance tend to be lower.
Future Price Projections
Factors Impacting Price
- Patent and Exclusivity Status: As a generic, no patent protection exists, but manufacturing exclusivity periods can influence wholesale prices.
- Supply Chain Dynamics: Increased regulation and REMS program restrict supply, potentially driving prices upward.
- Market Demand: Steady demand among treatment-resistant epileptic patients, with no significant new competitors expected soon.
- Manufacturing Costs: Slight inflation-adjusted increases expected due to raw material and regulatory compliance costs.
Forecast (Next 3 Years)
| Year |
Predicted Wholesale Price |
Rationale |
| 2024 |
$670–$700 |
Supply constraints may elevate prices; moderate inflation |
| 2025 |
$700–$730 |
Stabilization expected; minor increases due to inflation |
| 2026 |
$730–$760 |
Continued supply tightness unless new entrants emerge |
Market Entry and Pricing Strategies
- For Generics Manufacturers: Price competition likely to keep prices near current levels, barring supply disruptions.
- For Innovators: Development of safer alternatives or diagnostic tools could shift demand patterns, impacting pricing.
Regulatory & Policy Outlook
- Increasing emphasis on drug safety surveillance may tighten restrictions, possibly limiting supply and increasing costs.
- Government agencies exploring policies to reduce medication costs might influence future pricing.
Key Takeaways
- The drug remains a niche anticonvulsant with stable but limited market penetration.
- Price stability is expected with gradual increases, influenced by supply constraints and inflation.
- Regulatory restrictions continue to limit broader use, supporting steady demand but preventing significant price drops.
- Competition from newer therapies or biosimilars is minimal at present.
- Monitoring regulatory changes and supply chain developments will be crucial for accurate market and price assessment.
FAQs
1. What are the primary factors influencing Vigabatrin’s market price?
Supply constraints due to REMS, manufacturing costs, and demand stability drive pricing. Regulatory restrictions limit supply, elevating costs.
2. How does the REMS program impact the drug's market?
REMS requires prescriber qualification, patient monitoring, and limits shipment, reducing prescription volume and market accessibility.
3. Are there any upcoming patent protections for this drug?
As a generic, Vigabatrin does not have patent protections. Patent exclusivity areas may pertain to formulation patents for branded versions.
4. What are the prospects for new competitors entering this market?
Limited, given the niche indication and safety concerns; treatments like vigabatrin have restricted use, decreasing incentive for new entrants.
5. How do insurance plans typically cover Vigabatrin?
Coverage varies; most plans include it with copayments generally below $50 per month. Prior authorization may be required.
References
- Food and Drug Administration. (2009). Sabril (Vigabatrin) prescribing information. Retrieved from https://www.fda.gov
- IQVIA. (2022). Pharmaceutical Market Reports.
- Medscape. (2023). Anticonvulsants Market Overview.
- Centers for Medicare & Medicaid Services. (2023). Drug coverage policies.
- Drugs.com. (2023). Vigabatrin Prices & Coupons.
