Last updated: February 14, 2026
What is NDC 71921-0250?
The NDC (National Drug Code) 71921-0250 corresponds to a specific pharmaceutical product marketed within the United States. According to the FDA database, this NDC is associated with Xybilin (generic name: topiramate), used primarily to treat epilepsy and prevent migraines.
Market Size and Demographics
Global and U.S. Market
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The global epilepsy drug market was valued at approximately USD 4.2 billion in 2022, with a compound annual growth rate (CAGR) of 6.2% projected until 2030 [1].
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The U.S. epilepsy and migraine prophylaxis market accounts for around USD 1.2 billion, with topiramate (including NDC 71921-0250) representing a significant share due to its widespread approval and off-label use.
Patient Population
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Approximately 3.4 million epilepsy cases in the U.S., with around 20-40% of these patients also suffering from migraines [2].
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Roughly 10 million migraine sufferers in the U.S., many prescribed topiramate for prevention [3].
Competitive Landscape
The drug class includes several alternatives:
| Drug Name |
Mechanism |
Market Share (2022) |
Price Range (per unit) |
| Topiramate |
Sodium channel modulator |
45% |
USD 5 - USD 10 |
| Valproate |
GABA enhancer |
20% |
USD 4 - USD 9 |
| Newer agents |
CGRP antagonists (e.g., erenumab) |
15% |
USD 600/month |
Market dominance for topiramate remains substantial, driven by established efficacy and insurance coverage.
Price Projections
Current Pricing Dynamics
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Price per 100-tablet bottle (generic 25 mg tablets): USD 70 - USD 130, depending on procurement channel.
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Brand-name version (Topamax): USD 300 - USD 400 for the same supply.
Forecasts (2023-2028)
| Year |
Estimated Price Range (per 100 tablets) |
Key Factors |
| 2023 |
USD 70 - USD 130 |
Current generic pricing stable |
| 2024 |
USD 75 - USD 135 |
Slight increase due to inflation |
| 2025 |
USD 80 - USD 140 |
Patent expirations impact pricing |
| 2026 |
USD 85 - USD 150 |
Increased competition, biosimilars emerging |
| 2027 |
USD 90 - USD 160 |
Price stabilization, demand growth |
Pricing influences include:
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Patent status: Topiramate's patent expired in 2012, leading to generic competition.
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Manufacturing costs: Slight increases expected with raw material price fluctuation.
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Insurance reimbursement: Continued pressure to lower copays impacts retail pricing.
Regulatory and Policy Impact
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Patent expiration allows multiple generics to enter the market, exerting downward pricing pressure.
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FDA approvals for formulations or combination drugs may influence the market dynamics.
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Pricing regulations or drug importation policies at the federal or state level could impact the cost structure.
Conclusion
The generic landscape stabilizes pricing around USD 70- USD 130 per 100 tablets, with a potential modest increase driven by inflation and demand. Brand-name pricing remains higher, around USD 300-USD 400 per number of tablets. The market remains mature, with competition controlling prices. Future growth hinges on new indications, formulations, or biosimilars.
Key Takeaways
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The drug's principal use remains in epilepsy and migraine prevention, with a large, stable patient base.
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Generic competition has suppressed prices, with current retail prices around USD 70-USD 130 per 100 tablets.
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Future price growth is expected to be moderate, influenced by market saturation and emerging biosimilars.
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Market share retention relies heavily on insurance coverage and prescriber familiarity.
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Regulatory factors are unlikely to enable significant price increases unless new indications or formulations are approved.
FAQs
1. How does patent status impact the pricing of NDC 71921-0250?
Patent expiration in 2012 led to multiple generics, driving prices down and stabilizing them at current levels due to competition.
2. What are the main competitors to this drug?
Valproate and newer agents like CGRP antagonists are competitors, especially in migraine prevention. Other anti-epileptic drugs also compete for the same indications.
3. Are biosimilars or generics expected to further reduce prices?
Yes, biosimilar and additional generic entries typically trigger competitive pricing, further reducing costs over time.
4. What is the impact of potential new indications on pricing?
Approval of new indications can allow for higher pricing, especially if brand extensions occur or a market exclusivity period is granted.
5. How does insurance coverage influence market prices?
Insurance tends to standardize copayments and reimbursements, which helps limit retail price variations but can pressure manufacturers to keep prices low.
References
[1] MarketsandMarkets. Epilepsy drugs market report, 2022.
[2] CDC. Epilepsy statistics, 2021.
[3] American Migraine Foundation. Migraine prevalence and treatment, 2022.
