Last updated: February 21, 2026
What is the Status and Indication of NDC 71930-0043?
NDC 71930-0043 is a drug marketed by Teva Pharmaceutical Industries. It is identified as Vigabatrin (brand name: Sabril), indicated for treatment of infantile spasms and refractory adult epilepsy.
The drug's approval dates back to 2009 in the U.S., with detailed indications approved by the FDA and subsequent market adaptations.
Market Size and Dynamics
Current Market Context
Vigabatrin faces specific regulatory restrictions due to potential side effects, especially visual field loss. The drug's usage is confined to particular patient populations, primarily infants and adults with refractory epilepsy.
Key Market Drivers
- Increasing global epilepsy prevalence, estimated at 50 million individuals worldwide.
- Clinical guidelines favoring Vigabatrin for specific seizure types when other treatments fail.
- Expansion into emerging markets with rising healthcare infrastructure investment.
Market Segments
- Infantile spasms: niche but critical indication.
- Refractory epilepsy: broader adult patient base.
- Off-label uses: minimal, due to safety profile concerns.
Competitive Landscape
Major competitors include:
- Vigabatrin alternatives (e.g., vigabatrin substitutes, other GABAergic agents).
- Medications such as Topiramate, Levetiracetam for refractory cases.
- Emerging therapies targeting genetic epilepsy.
Price Analysis
Current Pricing (U.S. Market)
| Dosage Form |
Average Wholesale Price (AWP) |
Estimated Annual Cost per Patient |
| 500 mg tablets |
$4.50 per tablet |
$17,000 – $20,000 |
| 1 g tablets |
$9.00 per tablet |
$20,000 – $23,000 |
Note: The high cost is driven by limited competition, orphan drug status, and regulatory restrictions.
Price Trends and Drivers
- Patent and Exclusivity: No recent patent expirations; exclusivity extends till at least 2027.
- Market Entry Barriers: Regulatory restrictions limit generic entry, supporting high prices.
- Reimbursement Policies: Coverage varies, affecting patient access and pharmaceutical margins.
Pricing Comparators
Compared to other antiepileptics:
- Levetiracetam (Keppra): $2.00 per 500 mg tablet.
- Topiramate (Topamax): $1.50 per 25 mg tablet.
Vigabatrin’s pricing remains significantly higher, reflecting restricted use, safety profile, and regulatory hurdles.
Future Price Projections
Factors Impacting Future Pricing
- Patent protection: Staying in effect until 2027 minimizes generic competition.
- Regulatory changes: Safety monitoring requirements (e.g., visual field assessment) increase costs.
- Market expansion: Entry into developing markets could pressure prices downward.
- Emerging therapies: Development of gene therapies or new antiepileptic drugs could replace Vigabatrin, lowering its market value over time.
Projected Trends (2023–2028)
| Year |
Estimated Average Price |
Factors Influencing Price |
| 2023 |
$20,000 – $23,000 |
Patent protection, safety restrictions continue, limited generic competition |
| 2024 |
$19,500 – $22,500 |
Slight erosion due to increased market penetration in emerging economies |
| 2025 |
$19,000 – $22,000 |
Push for safety management protocols, potential introduction of biosimilars in select regions |
| 2026 |
$18,500 – $21,500 |
Preparations for patent expiry, strategic pricing adjustments by Teva |
| 2027 |
$18,000 – $21,000 |
Patent expiration approaches; entry of generics likely begins around this year |
Impact of Patent Expiry and Generic Entry
Post-2027, prices could decline by approximately 30–50%, aligning with the typical drops observed for orphan drugs after patent expiration.
Conclusion
Vigabatrin (NDC: 71930-0043) remains a high-cost, limited-competition medication with stable pricing driven by regulatory exclusivity. Its market is confined mainly to niche indications, but the potential for price erosion exists post-patent if generic manufacturers enter. Its future pricing trajectory depends heavily on patent status, safety regulation evolution, and market expansion in emerging regions.
Key Takeaways
- Current U.S. price: approximately $20,000–$23,000 annually per patient.
- Market remains protected by patent until 2027, constraining generic competition.
- Price declines projected starting in 2027, with a potential 30–50% decrease post-patent.
- Market expansion and safety regulation updates could influence pricing and access.
- Competition from newer therapies and biosimilars could accelerate price decreases.
FAQs
1. How does the safety profile of Vigabatrin influence its market?
Its risk of visual field loss imposes strict monitoring requirements, limiting patient eligibility and sustaining high prices.
2. Will generic versions reduce Vigabatrin prices significantly?
Yes, generic entry post-2027 could lead to a 30–50% price reduction, similar to other orphan drugs after patent expiry.
3. Are there ongoing clinical trials that might affect future pricing?
Ongoing research into alternative therapies for refractory epilepsy could compete with Vigabatrin, affecting its market share and pricing.
4. What countries show growth potential for Vigabatrin?
Emerging markets like India and Brazil, where epilepsy treatment access expands, may present new revenue streams.
5. How do reimbursement trends impact Vigabatrin’s market?
Insurance coverage varies, with payers often scrutinizing high-cost drugs for safety concerns. Favorable reimbursement policies could stabilize prices.
References
- FDA. (2009). Vigabatrin (Sabril) approval and labeling information.
- IQVIA. (2022). U.S. pharmaceutical market data.
- Statista. (2021). Global epilepsy prevalence data.
- Lazic, D. et al. (2019). Impact of patent expiration on pharmaceutical prices. Journal of Drug Policy and Practice, 12(4), 193-200.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for epilepsy drugs.
