Last updated: February 25, 2026
What Is NDC 00228-2631?
NDC 00228-2631 corresponds to Carbamazepine Oral Suspension, a generic anticonvulsant and mood stabilizer used primarily for epilepsy, trigeminal neuralgia, and bipolar disorder.
Market Overview
Current Market Position
Carbamazepine oral suspension faces competition from multiple formulations, including tablets and extended-release versions. Its market share is influenced by factors such as formulation preference, patent status, and manufacturing costs.
Key Competitors
- Tegretol (brand name)
- Equetro
- Other generic carbamazepine products in capsule and tablet forms
Market Size & Growth
Based on IQVIA data (2022), the US anticonvulsant market was valued at approximately USD 1.8 billion with a compound annual growth rate (CAGR) around 2% over the past five years.
- Oral suspension segment: Represents roughly 10-15% of total carbamazepine prescriptions due to preferences for tablets unless specific patient needs (e.g., pediatric, swallowing difficulties).
Regulatory Status
The drug is available as a closed system generic with no current patent protections, allowing multiple manufacturers to produce it.
Market Dynamics
Demand Drivers
- Pediatric and adult epilepsy treatment
- Trigeminal neuralgia management
- Bipolar disorder, especially in patients with swallowing challenges
Barriers
- Formulation limitations: Oral suspension is less common than tablets; limited shelf life and stability factors.
- Prescriber preference: Doctors often prefer tablets due to ease of manufacturing and longer shelf life.
- Pricing pressures: Increased generic competition is driving down prices.
Pricing Factors
- The average wholesale price (AWP) for carbamazepine suspension in late 2022 was around USD 50–USD 60 per 100 mL (30-day supply).
- Generic versions typically retail for 30–50% less than brand-name equivalents.
Pricing Projections
Historical Trends
| Year |
Average Wholesale Price (USD) |
Notable Changes |
| 2018 |
USD 70– USD 85 |
Regulatory stabilization post patent expiry |
| 2020 |
USD 55– USD 65 |
Increased generic competition |
| 2022 |
USD 50– USD 60 |
Extended competition and pricing pressure |
Short-term (2023–2025)
Prices are expected to decline gradually as more generics enter, with AWP potentially dropping by 10–15% annually. The suspension's limited demand relative to tablets constrains significant pricing increases.
Long-term (2026–2030)
- Prices may stabilize around USD 35– USD 45 per 100 mL, assuming no formulation innovations or patent disputes.
- Market share could shift if new formulations or delivery methods (e.g., patches) gain regulatory approval.
Volume Forecast
Annual prescriptions are expected to decrease slightly from approximately 2 million units in 2022 to about 1.8 million units by 2025, driven by market saturation and substitution with tablet formulations.
Regulatory Impact on Pricing
No recent patent protections or exclusivity periods influence price trends. If a biosimilar or alternative delivery system receives FDA approval, pricing could further decline.
Strategic Considerations
- Manufacturers should consider cost-reduction strategies to maintain margins.
- Entry into niche markets, such as pediatric formulations with extended shelf life, offers growth opportunities.
- Price competition will intensify with entry of additional generics post-2022.
Key Takeaways
- NDC 00228-2631 (Carbamazepine oral suspension) faces significant price erosion driven by generic competition.
- The current retail price ranges from USD 50–USD 60 per 100 mL.
- Market volume is stabilizing with a slight decline forecasted over the next five years.
- Pricing is likely to reach USD 35–USD 45 within five years, assuming no innovation or regulatory disruption.
- Companies should closely monitor the entry of new generics and formulations that could reshape the market landscape.
FAQs
1. How does the price of carbamazepine oral suspension compare across different regions?
Pricing varies geographically; in Europe, prices tend to be 20–30% lower due to different healthcare systems and regulatory environments.
2. Will patent expirations significantly impact the market?
No. The drug’s patent expired years ago, leading to widespread generic availability and downward pricing pressures.
3. Are there any upcoming regulatory changes affecting this drug?
No current FDA or international regulatory changes are expected to directly impact carbamazepine suspension pricing or market access.
4. What alternative formulations are gaining market share?
Extended-release tablets and compounded formulations are preferred for some indications, reducing reliance on suspension.
5. How can manufacturers differentiate their products?
By offering formulations with improved stability, flavoring for pediatric use, or lower pricing due to manufacturing efficiencies.
References
- IQVIA. (2022). US Prescription Market Data.
- U.S. Food and Drug Administration. (2022). Drug Approvals and Regulatory History.
- NADAC. (2022). National Average Drug Acquisition Cost Data.
- First DataBank. (2022). Drug Pricing Reports.
- FDA. (2021). Generic Drug Labeling and Market Status Updates.
[1] IQVIA (2022). Prescription drug market reports.
[2] FDA (2022). Drug approvals and label updates.
