Last updated: February 16, 2026
Current Market Position
Product Overview
NDC 00078-0696 refers to a generic formulation of gabapentin, an anticonvulsant medication used primarily for neuropathic pain, seizures, and off-label conditions such as anxiety and restless leg syndrome. It is marketed by several manufacturers in multiple formulations, including capsules, tablets, and oral solutions.
Market Size
The global gabapentin market was valued at approximately $2.2 billion in 2022, driven by increasing prevalence of neuropathic pain and epilepsy. The US market accounted for roughly 45% of this value, with consistent growth rates projected around 4-6% annually over the next five years.
Key Drivers
- Growing incidence of diabetic neuropathy and shingles
- Expanded off-label use for anxiety and insomnia
- Cost competitiveness of generic formulations vs. brand-name drugs
- Increasing adoption in outpatient and long-term care settings
Major Competitors
- Pfizer (Neurontin; phased out in favor of generics)
- Teva Pharmaceuticals
- Mylan (now part of Viatris)
- Accord Healthcare
- Sun Pharmaceutical Industries
Regulatory and Patent Landscape
Patent Status
Gabapentin's patents have expired in most jurisdictions, leading to widespread generic entry since 2004. The primary patent expiration enabled market entry of generics, including NDC 00078-0696, which is produced by multiple manufacturers.
Regulatory Changes
The FDA approved generic gabapentin formulations starting from 2004. No current restrictions or new formulations for this specific NDC are pending approval, maintaining steady generic availability.
Price Trends and Projections
Historical Price Data (US Estimates)
- Average wholesale acquisition cost (WAC) for a 300 mg generic capsule: approximately $0.20–$0.25 per capsule (2022)
- Retail prices vary by provider and volume; typical cash prices range from $0.50 to $1.00 per capsule
Current Pricing Factors
- Increased competition among generic manufacturers has driven prices downward from peak levels in early 2010s.
- Bulk purchasing through pharmacy benefit managers (PBMs) and managed care organizations reduces net costs.
- Wide availability prevents significant price inflations.
Projected Price Dynamics (2023–2027)
- Price stability expected due to high generic market saturation.
- Marginal decrease anticipated as entry continues and manufacturing efficiencies improve.
- No major price hikes forecast unless new formulations or indications emerge.
Forecast Summary
- The cost per capsule for NDC 00078-0696 is projected to hover around $0.20–$0.22 through 2027.
- Wholesale prices in bulk purchase are likely to decrease marginally by 1-2% annually.
- Retail and cash prices may fall slightly as market competition maintains pressure on profit margins.
Market Opportunities and Risks
Opportunities
- Expansion into new markets with unmet needs, especially in developing countries.
- Development of combination therapies or extended-release formulations.
- Pediatric or specialized indications could create new pricing structures.
Risks
- Emergence of branded competitors with patent extensions or new formulations.
- Regulatory changes potentially restricting off-label use.
- Price erosion due to increased generic competition.
Key Takeaways
- The overall gabapentin market remains large, stable, and highly competitive due to patent expirations and multiple manufacturers.
- Price projections for generic NDC 00078-0696 remain flat or slightly declining through 2027, with prices stabilizing around $0.20–$0.22 per capsule.
- Market growth relies on expanding indications rather than price increases, with opportunities in emerging markets.
- Competitive pressure limits pricing power, with the risk of price erosion if new generics or formulations enter.
FAQs
Q1: Will the price of NDC 00078-0696 increase in the next five years?
A1: No. Prices are expected to remain flat or decline slightly due to high generic competition and manufacturing efficiencies.
Q2: Are there patent protections still in effect for gabapentin?
A2: Patent protections have largely expired globally since 2004, enabling widespread generic entry.
Q3: What factors influence the pricing of generic gabapentin?
A3: Competition among manufacturers, procurement volume, market demand, and payer negotiations.
Q4: Could new formulations or indications impact the market?
A4: Yes. Extended-release versions or new approved indications could affect pricing and market dynamics, but no approvals are anticipated soon.
Q5: How does the global market differ in pricing?
A5: Prices tend to be lower in emerging markets due to regulatory differences, manufacturing costs, and purchasing power.
References
- MarketWatch, "Gabapentin Market Size, Share & Industry Trends," 2022.
- U.S. Food and Drug Administration, "Generic Drug Approvals," 2022.
- IQVIA, "Pharmaceutical Market Data," 2022.
- EvaluatePharma, "Global Generics Market Outlook," 2022.
- Health Affairs, "Pricing Trends in Generic Pharmaceuticals," 2021.
