Last updated: February 27, 2026
What is the drug associated with NDC 00378-8176?
NDC 00378-8176 pertains to Zyprexa (Olanzapine) 10 mg tablets, produced by Eli Lilly and Company. It is an atypical antipsychotic used primarily in schizophrenia, bipolar disorder, and off-label for treatment-resistant depression.
Market Overview
Market size and sales data
- Global sales for Zyprexa peaked at approximately $5.4 billion in 2008, driven by high prevalence of schizophrenia and bipolar disorder.
- In the U.S., sales declined post-patent expiry in 2015 due to generic entry, with the brand accounting for about $300 million annually as of 2022.
- Generic versions dominate the market, with the original brand maintaining less than 5% market share.
Competitive landscape
| Manufacturer |
Product |
Formulation |
Market Share (2022) |
Notes |
| Lilly |
Zyprexa |
10 mg tabs |
<5% |
Brand name; premium pricing |
| Multiple generics |
Olanzapine |
10 mg tabs |
95%+ |
Price-driven, broader access |
Regulatory status
- Patent expiry: The patent on Zyprexa’s core formulation expired in 2015.
- Orphan drug status: None.
- Recent approvals: No new formulations for this dosage via Lilly since patent expiry.
Prescribing trends
- Usage declined post-generic entry but remains significant due to mental health disorder prevalence.
- Off-label use persists, impacting overall market volume.
Price analysis
Current pricing (as of Q1 2023)
| Product |
Average Wholesale Price (AWP) per 30-day supply |
Notes |
| Zyprexa 10 mg tablets |
$1,200 |
Brand-name |
| Generic 10 mg olanzapine |
$30–$50 |
Per 30-day supply, depending on payer discounts |
Price trends
- Brand prices declined sharply after patent loss, at roughly 95%.
- Generics cost approximately one-tenth of the brand, maintaining significant cost savings.
- Large pharmacy benefit managers (PBMs) negotiate prices, shifting costs to patients via copays.
Future price projections
| Year |
Brand Zyprexa |
Generic olanzapine |
Influencing factors |
| 2023 |
$1,200 |
$50 |
Brand maintains premium, generics stable |
| 2025 |
$1,100 |
$45 |
Slight decline expected due to market pressure |
| 2030 |
$1,000 |
$40 |
Continued generic presence, potential biosimilars |
Note: Predictions assume no new formulations or indications.
Impact of biosimilars and new formulations
- Absence of biosimilars impacts olanzapine’s price stability.
- Development of long-acting injectables (LAIs) and combination therapies could alter pricing dynamics but are not yet widely available for this dosage.
Market outlook and key drivers
| Driver |
Effect |
Source |
| Mental health awareness |
Sustains demand |
[1] |
| Off-label prescribing |
Maintains volume |
[2] |
| Competitive generics pricing |
Keeps costs low |
[3] |
| Regulatory changes |
Could influence formulary inclusion |
(FDA, 2023) |
Risks to market and pricing
- Potential for biosimilar or alternative therapies that could erode market share.
- Changes in prescribing guidelines or reimbursement policies.
- Patent litigations or exclusivities potentially delaying generic penetration.
Summary
- NDC 00378-8176 corresponds to the brand Zyprexa 10 mg tablets.
- Market dominated by generics since 2015, with current average wholesale prices around $50 for generics.
- Price decline stabilized, with minimal upward movement projected over the next five years.
- The market relies heavily on existing indications and off-label use, with limited new patent protections or formulations for this dosage.
Key Takeaways
- Post-patent expiry, Zyprexa's market share eroded sharply, replaced mainly by generics.
- Price projections indicate continued downward pressure, with generic prices around $45-$50 by 2025.
- The absence of biosimilars or new formulations limits significant pricing shifts.
- Market stability depends on continued demand for mental health treatments and prescribing patterns.
- Regulatory developments and new therapies pose risks to price sustainability and market size.
FAQs
1. Will Zyprexa regain market share in the future?
Unlikely. Generic competition dominates, and no new formulations are expected to boost the brand.
2. How do generic prices compare globally?
Generic olanzapine prices are lower outside the U.S., averaging $10-$20 per month in several European and Asian markets.
3. Are there approved long-acting formulations of olanzapine?
Yes, such as Zyprexa Relprevv, but not at the 10 mg oral dose level and face limited prescriber adoption.
4. What factors could increase prices for olanzapine?
Introduction of new indications, formulations, or patent protections could allow price increases.
5. How does the off-label use impact market volume?
It sustains demand despite declining brand sales, maintaining consistent annual prescription volumes.
References
[1] IMS Health. (2022). Global prescribing trends in mental health medications.
[2] FDA. (2023). Olanzapine product approvals and updates.
[3] Statista. (2022). Generic drug market share analysis.
