Last updated: February 24, 2026
What is the drug associated with NDC 00054-0088?
NDC 00054-0088 corresponds to Gabapentin Capsules, 300 mg manufactured by Pfizer. It is used primarily for nerve pain, epilepsy, and postherpetic neuralgia.
Current Market Landscape
Industry Overview
The gabapentin market has experienced increased volume due to expanded indications and generic availability. As of 2023, the U.S. market's sales volume surpasses 150 million units annually, with a value estimated at $1.8 billion.
Competitive Environment
- Branded Version: Pfizer's Neurontin (now discontinued in the U.S. market for new prescriptions) had been dominant before patent expiration.
- Generics: Multiple manufacturers produce gabapentin, including Teva, Mylan, and Sandoz.
- Market Share: Generic gabapentin accounts for over 85% of prescriptions in the U.S.
Patent and Regulatory Status
- Patent Expiry: Pfizer's patent protections for Neurontin expired in 2004, leading to widespread generic entry.
- Regulation: FDA approved generic versions meet bioequivalence standards.
Distribution Channels
- Retail pharmacies dominate, accounting for roughly 70% of prescriptions.
- Hospital and specialty clinics contribute to 20-25%, primarily for severe neurological cases.
Price Dynamics
Historical Price Trends
- Brand-name Gabapentin (Neurontin): Historically priced at approximately $7 per capsule.
- Generic Gabapentin: Initial prices around $1.50 to $3 per capsule, decreasing over time due to market saturation.
Current Price Points (2023)
- Retail Pharmacy: $0.90 - $1.20 per capsule for generics.
- Bulk/Electronic Purchases: Prices can drop below $0.80 per capsule in wholesale transactions.
Price Variability Factors
- Formulation and Packaging: Capsules in blister packs usually cost more than bottles.
- Payer Contracts: Insurance plans and pharmacy benefit managers negotiate significant discounts.
- Geographic Factors: U.S. and European prices vary, with the U.S. typically higher due to market structure.
Future Price Projections (2023-2028)
Assumptions
- Market remains saturated with generics.
- No significant patent or exclusivity periods re-emerge.
- Regulatory environment remains stable.
- Demand continues at current levels, barring new indications or formulations.
Price Trends Forecast
| Year |
Projected Price Range per Capsule |
Explanation |
| 2023 |
$0.80 - $1.20 |
Stable, with minor fluctuations due to inflation and purchasing trends. |
| 2024 |
$0.75 - $1.10 |
Slight decline expected due to market saturation. |
| 2025 |
$0.70 - $1.00 |
Continued downward pressure as manufacturing efficiencies improve. |
| 2026 |
$0.65 - $0.90 |
Market stabilization expected; volume remains high. |
| 2027 |
$0.60 - $0.85 |
Cost-led pricing with no new market entrants. |
| 2028 |
$0.55 - $0.80 |
Prices plateau at lower levels with stable generic supply. |
Factors Impacting Price Movement
- Regulatory Changes: Stricter generic approval processes could temporarily increase prices.
- Manufacturing Costs: Slight reductions in production costs could further compress prices.
- New Indications: If new, lucrative indications are approved, prices might stabilize or increase temporarily.
- Supply Chain Disruptions: As seen during COVID-19, shortages can cause price spikes but are unlikely in mature markets.
Market Entry and Forecast Opportunities
- Generic Expansion: Continued entry of new generic manufacturers will sustain downward pricing pressure.
- Scaling Production: Larger batch sizes reduce unit costs, further lowering prices.
- Distribution Efficiency: Electronic and mail-order pharmacies enhance logistics and reduce overhead, pushing prices down.
Strategic Recommendations
- Companies should monitor patent status and regulatory updates.
- Focus on cost-effective production to remain competitive.
- Evaluate potential for niche or specialized formulations that could command higher prices if new indications emerge.
Key Takeaways
- The NDC 00054-0088 drug, marketed as generic gabapentin capsules, dominates with over 85% market share.
- Prices are expected to decline gradually, stabilizing around $0.55 to $0.80 per capsule by 2028.
- Market saturation and manufacturing efficiencies will be primary drivers of price trends.
- A stable regulatory environment and consistent demand underpin the forecast.
- Opportunities lie in production cost optimization and identification of new indications.
FAQs
1. Does patent protection influence gabapentin pricing?
No. The patent expired in 2004, which led to widespread generic competition, significantly lowering prices.
2. Are there significant regional price differences?
Yes. U.S. prices tend to be higher due to market structure, insurance negotiations, and healthcare costs, compared to Europe and other regions.
3. Could regulatory actions impact prices?
Potentially. Stricter bioequivalence standards or approval processes could temporarily increase costs, but generally, the market remains competitive.
4. How do supply chain disruptions affect prices?
Difficulties in manufacturing or distribution can cause temporary price increases, though these are typically short-term unless persistent.
5. Are newer formulations or delivery methods emerging?
Most market activity involves generics, but novel delivery systems or formulations would require regulatory approval and could command higher prices.
References
- IQVIA. (2023). Pharmaceutical Market Insights.
- U.S. Food and Drug Administration. (2022). Generic Drug Approvals.
- Centers for Medicare & Medicaid Services. (2023). National Prescription Drug Utilization Data.
- IMS Health. (2023). Global Market Reports.
- Statista. (2023). Gabapentin Market Overview.
