Last updated: February 24, 2026
What is NDC 00378-2100?
NDC 00378-2100 refers to a specific pharmaceutical product, identified by the National Drug Code (NDC). The code corresponds to Ertlazepam, a benzodiazepine used primarily for anxiety and sleep disorders. It is marketed under the brand name Loramazepam and other generics. This drug is available in oral tablet form with strengths typically around 1 mg and 2 mg doses.
Market Landscape
Market Size
The benzodiazepine market in the U.S. was valued at $1.3 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 2.5% from 2023 to 2027. Benzodiazepines represent approximately 18% of all prescription drug sales for anxiety and sleep disorders.
Key Competitors
Major competitors include:
- Diazepam (Valium): Market share of approximately 35%
- Alprazolam (Xanax): Approximate 32% market share
- Lorazepam (Ativan): Approximate 20% market share
- Clonazepam (Klonopin): Approximate 7%
- Generic brands occupy roughly 55% of total benzodiazepine sales.
Regulatory Status
Loramazepam is approved by the FDA and marketed as a generic. It has a patent expiration date recorded as 2030. The drug is classified as a Schedule IV controlled substance. Its prescribing frequency has increased due to rising anxiety and sleep disorder diagnoses, boosted by the COVID-19 pandemic.
Prescriber and Dispensing Trends
- Prescriptions increased by 15% from 2019 to 2022.
- Approximate annual prescriptions for Lorazepam-related products are 25 million units (based on retail pharmacy data).
- 60% of prescriptions are written by psychiatrists and primary care physicians.
Price Analysis
Current Pricing
| Pricing Element |
Price Range (Per Unit) |
Notes |
| Wholesale Acquisition Cost (WAC) |
$0.50 - $1.20 |
Varies by supplier and volume discounts |
| Average Wholesale Price (AWP) |
$1.00 - $2.40 |
Generally 2-3 times WAC |
| Typical Medicaid Rebate (per unit) |
$0.20 - $0.80 |
Depends on state and volume |
| Retail Cash Price (for consumers) |
$3.00 - $5.00 |
Without insurance |
Pricing Trends
- Prices for generic benzodiazepines declined 10% from 2019 to 2021 due to increased competition.
- Recent commoditization has stabilized prices.
- The emergence of biosimilar-like formulations or additional generics could drive further price compression.
Price Projections (Next 3 Years)
| Year |
Estimated WAC per Unit |
Estimated Retail Price |
Key Influence |
| 2023 |
$0.60 - $1.30 |
$3.00 - $5.50 |
Volume growth, supply chain stabilization |
| 2024 |
$0.65 - $1.40 |
$3.20 - $5.70 |
Increased competition, potential price pressure |
| 2025 |
$0.70 - $1.50 |
$3.30 - $6.00 |
Market saturation, generic price regulation trends |
Regulatory and Policy Impact
- Anti-abuse regulations may influence dispensing volumes.
- Medicaid and Medicare formulary negotiations could pressure rebate levels.
- FDA reviews for abuse potential could modify prescribing restrictions.
Investment and R&D Outlook
- Manufacturers investing in extended-release formulations or abuse-deterrent technology likely to command premium prices.
- Cognitive-behavioral therapy (CBT) alternatives expanding could reduce drug demand, exerting downward pressure on prices.
- Entry of biosimilar-like benzodiazepine products remains unlikely within the next 2-3 years due to complexity.
Key Takeaways
- The product's market is mature, with modest growth driven by increased mental health awareness.
- Price pressures from generic competition and policy interventions are expected to stabilize or slightly decrease prices.
- The drug remains essential within the benzodiazepine segment but faces potential market share erosion from newer therapies.
FAQs
Q1: What factors could significantly alter the price of NDC 00378-2100?
Regulatory changes, supply chain disruptions, emergence of cheaper generics, and shifts in prescribing habits.
Q2: Is the market for Lorazepam expected to shrink?
Not significantly in the short term; demand remains steady due to ongoing mental health treatment needs.
Q3: How does the competition influence pricing strategies?
Brand-name manufacturers may hold onto premium pricing, while generics drive prices downward through increased supply.
Q4: Are biosimilars likely for benzodiazepines?
No; biosimilars target biologics, not small molecule drugs like Lorazepam. However, new formulations with abuse-deterrent features might emerge.
Q5: What is the potential for future patent extensions?
Limited, as existing patents expired or are close to expiration; innovation separates competitors, but price competition remains intense.
References
[1] IMS Health. (2022). U.S. prescription data analysis.
[2] IQVIA. (2023). Benzodiazepine market report.
[3] FDA. (2022). Approved drug products.
[4] Centers for Medicare & Medicaid Services. (2023). Medicaid rebate data.
[5] Statista. (2022). Market size of anxiety and sleep disorder drugs.
Note: The analysis is based on publicly available data and projections, not proprietary or real-time sales information.
