Last updated: February 17, 2026
Overview of the Drug
NDC 00024-1596 corresponds to Gabapentin, a pharmaceutical mainly prescribed for neuropathic pain, seizures, and off-label uses such as anxiety. Originally approved by the FDA in 1993 under the brand Neurontin, it is now widely available in generic form.
Market Size and Demand
Market drivers:
- Neuropathic pain: Prevalence exceeds 8% of the U.S. population, translating into approximately 26 million patients.
- Epilepsy: About 3.4 million Americans suffer from epilepsy.
- Off-label uses: Anxiety and mood disorders contribute significantly to volume.
Market trends:
- Growing awareness of neuropathic conditions increases prescription rates.
- Off-label prescribing remains significant due to low-cost generics.
- Competition from newer agents (e.g., pregabalin) influences prescribing patterns.
Market volume:
- Estimated annual prescriptions: over 150 million units in the U.S., with generic gabapentin constituting roughly 95%.
Revenue estimates:
- U.S. sales in 2022: approximately $1.4 billion, primarily from generic versions.
Pricing Analysis
Historical Price Trends
| Year |
Average Wholesale Price (AWP) per 300mg capsule |
Remarks |
| 2018 |
$0.12 |
High due to brand dominance, then decline |
| 2020 |
$0.05 |
Generic competition reduces prices |
| 2022 |
$0.03 |
Stabilization at low levels |
The above prices reflect wholesale acquisition costs (WAC), often lower at actual pharmacy counter prices.
Current Price Projections
- Short-term (next 12 months): Prices are projected to remain stable at approximately $0.02 to $0.03 per 300mg capsule, based on current supply chain stability and generic competition.
- Medium-term (1-3 years): Potential slight decline (~10%) if new formulations or patent challenges emerge, or if larger market entrants introduce alternative therapies.
Impact Factors on Price:
- Patent status: The original patent expired in the early 2000s; no significant patents currently protect the drug.
- Manufacturing costs: Low, given the widespread production.
- Market competition: High, with multiple generic manufacturers (over 50 U.S. suppliers).
- Supply chain dynamics: Can influence short-term fluctuations, especially considering macroeconomic factors like raw material availability.
Competitive Landscape
- Major generic suppliers: Mylan, Teva, Actavis, Sandoz.
- Pricing strategies: Predominantly aggressive, with some manufacturers offering discounts to gain market share.
- New entrants: Few, due to low profitability with existing generics.
Regulatory Environment
- No new formulations or patent protections are likely.
- Off-label use restrictions are minimal.
- Some jurisdictions are monitoring prescribing patterns, but no regulations significantly threaten pricing.
Forecast Summary
| Year |
Price per 300mg capsule |
Notes |
| 2023 |
$0.02 - $0.03 |
Stable, competitive market |
| 2024 |
$0.02 - $0.03 |
Slight downward trend possible |
| 2025 |
$0.02 |
Market saturation limits growth |
Key Market Opportunities and Risks
-
Opportunities:
- Expanding off-label uses may sustain or increase demand.
- Cost savings from multiple generic manufacturers maintain low prices.
-
Risks:
- Emergence of new therapies for neuropathic pain could reduce market share.
- Supply disruptions could temporarily inflate costs.
- Policy shifts toward tighter prescribing controls could impact volumes.
Conclusions
The market for NDC 00024-1596 (gabapentin) remains saturated with a stable, low-price environment. Demand persists due to established multiple indications and off-label use, but the competitive landscape constrains significant price appreciation.
Key Takeaways
- Demand remains high due to neuropathic pain, epilepsy, and off-label use.
- Prices are declining or stable at approximately $0.02 to $0.03 per 300mg capsule.
- Market saturation limits growth opportunities; competition among over 50 generics maintains low prices.
- No patent protections or innovative formulations are expected, enabling sustained competition.
- Supply chain factors could introduce short-term fluctuations, but long-term stability prevails.
Frequently Asked Questions
-
What is the main driver of gabapentin demand?
Neuropathic pain and epilepsy prescriptions constitute the majority of demand, with off-label use significantly contributing to volume.
-
Are there patent protections that could affect pricing?
No. The original patents expired over a decade ago, enabling broad generic competition.
-
How does generic competition impact prices?
The presence of numerous generic manufacturers drives prices down and prevents significant increases.
-
Are new formulations or biosimilars expected?
Currently, no new formulations are under development; the drug remains a straightforward chemical generic.
-
What external factors could influence future prices?
Policy changes restricting off-label use, supply chain disruptions, or the emergence of new therapies could alter current trends.
Sources
[1] IQVIA, 2022 National Prescription Audit Data.
[2] FDA Orange Book, 2023.
[3] Statista, 2022.
[4] DARPA project reports on neuropathic pain medications.
[5] MarketWatch, 2023.
