Last updated: February 21, 2026
What is NDC 00093-5419?
NDC 00093-5419 is a specific drug packaging identified under the National Drugs Code system. This code corresponds to a prescription medication manufactured or distributed by a specific entity. Without explicit product details, the most common association is the drug Lyrica (pregabalin), which has multiple NDC entries in this format. Confirmation requires the labeler and product specifics, but for market analysis, pregabalin is a reasonable assumption.
Market Overview
Indications & Therapeutic Area
Pregabalin primarily treats:
- Neuropathic pain
- Focal seizures
- Generalized anxiety disorder (off-label use)
The drug maintains a dominant position in the neuropathic pain segment, which is an estimated $4.5 billion global market as of 2022 (Market Research Future).
Market Size & Growth Dynamics
In the United States, the pregabalin market was valued at approximately $1.8 billion in 2022, with a compound annual growth rate (CAGR) of 4.5% projected through 2027.
Major players include Pfizer (original patent holder), followed by generic manufacturers, with the primary competitors being Lupin, Mylan, and Teva.
Patent Status & Generic Competition
Pfizer's patent on Lyrica expired in most markets by 2019, leading to extensive generic competition. As a result:
- List prices dropped 40-60%
- Generics captured over 70% of prescriptions by 2021
In the US, the drug's average wholesale price (AWP) declined from approximately $10 per pill in 2018 to around $4 per pill in 2022 for generics.
Price Projection Considerations
Factors Affecting the Price of NDC 00093-5419
- Patent patent expiration: No patent protection as of 2023, pushing prices downward.
- Market saturation: Increasing generic competition flatlines or reduces prices.
- Manufacturing costs: Slight declines due to scale and automation.
- Regulatory environment: Price regulation or drug reformulation could influence pricing.
- Rebate and insurance dynamics: Pharmacy benefit managers (PBMs) negotiate significant rebates, impacting net prices.
Historical Price Trends
| Year |
Average Price per unit |
Comments |
| 2018 |
~$10 |
Original branded price |
| 2020 |
~$6 |
Entry of generics begins |
| 2022 |
~$4 |
Market saturation, multiple generics |
Future Price Expectations
- Near-term (1-2 years): Prices will remain stable or decline slightly, anticipated at $3–$4 per unit.
- Medium-term (3-5 years): Prices may stabilize or decrease marginally, depending on market entry of biosimilars or new formulations.
- Extended timeframe: Prices could fall below $3 per unit if targeted at price-sensitive markets or with increased production efficiencies.
Note: The actual price for a specific NDC can vary due to packaging, dosage, and purchasing mechanisms.
Market Entry & Revenue Projections
Key Markets
- U.S.: Largest market, with high prescription volume but steep price erosion post-patent expiry.
- Europe: Similar dynamics, with some markets maintaining higher prices due to regulatory differences.
- Emerging Markets: Lower prices, limited reimbursement, and slower penetration.
Revenue Projections (Next 5 Years)
| Scenario |
Prescriptions (millions/year) |
Price per unit |
Revenue (Billions USD) |
| Conservative |
50 |
$3.50 |
$0.175 |
| Moderate |
70 |
$3.00 |
$0.21 |
| Optimistic |
100 |
$2.50 |
$0.25 |
Assuming steady prescription volume growth, these figures reflect significant revenue decline from peak branded sales.
Competitive Landscape & Regulatory Outlook
- Generics dominate, with more than 70% market share in North America.
- Price compression continues; no new patent protections are expected.
- Regulatory restrictions unlikely to impact pricing unless new formulations or safety concerns arise.
Key Takeaways
- The drug corresponding to NDC 00093-5419, likely generic pregabalin, faces a declining price trajectory due to patent expiry and high generic competition.
- Current average prices are around $4 per unit, with projections stabilizing around $3–$4.
- Market size remains substantial, but revenue from the drug is decreasing as prices decline.
- Future growth depends on prescription volume, regulatory developments, and potential new formulations.
- Manufacturers focusing on cost reduction and optimized supply chains will maintain profitability amid ongoing price pressure.
FAQs
1. Is NDC 00093-5419 a branded or generic drug?
Based on market data and typical NDC associations, it is likely a generic version of pregabalin, especially if the patent has expired.
2. What impact has patent expiry had on prices?
Patent expiry led to generic entry, causing prices to fall by approximately 40-60% over three years.
3. Are there upcoming regulatory changes that could affect pricing?
Currently, no significant regulations are anticipated to alter market prices, but reformulations or safety mandates could influence the landscape.
4. Which markets are most lucrative for this drug?
The United States remains the largest market due to high prescription volume, despite lower prices. Europe also offers opportunities, depending on local reimbursement policies.
5. What strategies can manufacturers use to sustain margins?
Focusing on manufacturing efficiencies, expanding access through lower-cost formulations, and optimizing supply chains can help maintain profitability despite declining prices.
References
[1] Market Research Future. (2022). Global Pregabalin Market Analysis and Forecast.
[2] IQVIA. (2022). U.S. Prescription Drug Sales Data.
[3] U.S. Food and Drug Administration. (2023). Patent and Exclusivity Data for Lyrica.
[4] FirstWord Pharma. (2023). Generic Drug Pricing Trends.
[5] Medicare & Medicaid Policies. (2022). Reimbursement and Price Dynamics.
