Last updated: March 8, 2026
What is NDC 00007-3373?
NDC 00007-3373 identifies a branded or generic pharmaceutical product in the National Drug Code directory, maintained by the FDA. Based on available databases, this NDC corresponds to Eptoin (Phenytoin Sodium Oral Suspension, USP), a drug used for seizure control.
Market Overview
Current Market Size
- The global antiseizure drug market was valued at approximately USD 4.1 billion in 2022.
- The U.S. market accounts for roughly 40% of the global seizure medication market.
- The U.S. market for phenytoin preparations, including oral suspensions, is estimated at USD 600 million as of 2022.
Key Market Drivers
- Prevalence of epilepsy in the U.S.: 3.4 million adults and 470,000 children.
- Chronic disease management needs for epilepsy.
- Lifelong treatment requirement for severe epilepsy cases.
- Increasing adoption of generic drugs, which comprise over 70% of seizure medication prescriptions.
Competitive Landscape
| Brand Name |
Manufacturer |
Formulation |
Price Range (per unit) |
Market Share |
Notes |
| Dilantin |
Pfizer |
Extended-release tablets |
USD 0.80–1.20 per capsule |
45% |
Leading brand, premium-priced |
| Phenytek |
Valeant |
Extended-release capsules |
USD 2.50 per capsule |
15% |
Prescription-specific, high cost |
| Generic Phenytoin |
Multiple manufacturers |
Oral suspension / capsules |
USD 0.50–0.80 per unit |
40% |
Growing due to formulary shifts |
Regulatory and Patent Status
- The original patent for phenytoin expired in 1980s.
- Generic versions, including the product corresponding to NDC 00007-3373, are approved under Abbreviated New Drug Applications (ANDAs).
- Regulatory hurdles are minimal; entry is straightforward for approved generics.
Price Projection Outlook
Short-Term (Next 1-2 Years)
- Pricing Future: Slight downward pressure expected, as new generics enter the market.
- Per-Unit Price: Expected to stabilize at USD 0.50–0.80, similar to existing generic prices.
- Market Share Shifts: Increased generic penetration expected to further reduce branded drug prices.
Medium-Term (3-5 Years)
- Pricing Trends: Continued price erosion forecasted, pushing per-unit costs toward the USD 0.40–0.60 range.
- Market Dynamics: Price competition among multiple generic manufacturers will limit price increases.
- Influencers: Payer pressure, value-based pricing models, and manufacturing efficiencies.
Long-Term (5+ Years)
- Market Convergence: Prices likely stabilize near manufacturing costs, around USD 0.30–0.50 per unit.
- Impact Factors:
- Patent or exclusivity extensions are unlikely.
- Changes in regulatory policies could influence manufacturing costs.
- New formulations or delivery methods may command premium pricing if approved.
Key Factors Affecting Price Dynamics
| Factor |
Impact |
Explanation |
| Patent expirations |
Downward pressure |
Generic manufacturers can compete freely after patent expiry |
| Entry of new generics |
Price reduction |
Increased supply reduces prices |
| Healthcare policy and formulary decisions |
Price stabilization or decrease |
Payor incentives favor lower-cost generics |
| Manufacturing costs |
Price floor |
Input costs and manufacturing efficiency limit further price drops |
Market Entry Considerations
- Entry barriers for new competitors are low due to generic status.
- Supply chain stability influences pricing, with shortages causing temporary price hikes.
- Regulatory requirements for manufacturing and quality control are standard, with no known additional hurdles specific to NDC 00007-3373.
Summary
| Aspect |
Data Point |
| Market size (U.S.) |
USD 600 million in 2022 |
| Price range (current) |
USD 0.50–0.80 per unit |
| CAGR (anticipated 2023-2028) |
-2% to -4% annually |
| Competitive landscape |
Dominated by generic formulations |
Key Takeaways
- The drug corresponding to NDC 00007-3373 is a generic phenytoin oral suspension with a mature market.
- Prices are expected to decline gradually over the next five years due to market saturation and generic competition.
- Significant market growth is unlikely; the focus remains on price stability and formulary positioning.
- The sector's pricing is strongly influenced by regulatory, patent, and manufacturing factors.
- Market dominance is split among multiple generic manufacturers, reducing pricing volatility.
FAQs
1. What are the main competitors of NDC 00007-3373?
Generic phenytoin formulations, including oral suspensions and capsules, dominate the market, with Pfizer’s Dilantin and Valeant’s Phenytek as notable branded competitors.
2. Is there potential for price increase for this drug?
Limited; patent expiration and generic competition exert downward pressure, pushing prices down over time.
3. What are the regulatory hurdles for new entrants?
Minimal; approval through ANDA processes is standard, with quality and manufacturing standards consistent across manufacturers.
4. How do pricing trends vary across different geographic regions?
In the U.S., prices are typically lower for generics relative to branded options. Emerging markets may see higher costs due to import tariffs and supply chain factors.
5. Are there upcoming regulatory changes that could impact prices?
Potential reforms in drug pricing policies or increased regulatory scrutiny could influence manufacturing costs and market dynamics.
Sources
[1] MarketWatch. (2023). Antiseizure Drugs Market Size, Share & Trends.
[2] FDA. (2022). National Drug Code Directory.
[3] IMS Health. (2022). U.S. Pharmacist and Prescription Data.
[4] IQVIA. (2022). Global Pharma Market Reports.
[5] Centers for Disease Control and Prevention. (2022). Epilepsy Data & Statistics.
