Last updated: February 15, 2026
What is NDC 00378-0757?
The drug identified as NDC 00378-0757 is Bupropion Hydrochloride Extended-Release (SR) 100 mg. It is used primarily for depression, smoking cessation, and seasonal affective disorder.
Market Overview
Indications and Demographics:
- Approved uses: Major depressive disorder (MDD), seasonal affective disorder (SAD), smoking cessation.
- Target populations: Adults, adolescents (age 18+), with a growing emphasis on mental health awareness impacting demand.
Market Size & Trends (2022–2023):
- The U.S. prescription volume exceeded 10 million units annually.
- Demand correlates with rising depression and smoking cessation initiatives.
- Competition includes brands like Wellbutrin SR, generic formulations, and formulations with similar active ingredients.
Clinical & Regulatory Factors:
- FDA approved in 1985, with patent expirations in the late 2000s.
- Generic availability increases price sensitivity.
- Recent approval for use in bipolar disorder phases has expanded indications in some regions.
Price Range & Historical Trends
Current Average Wholesale Price (AWP):
- Approximate AWP: $0.50 to $0.75 per 100 mg tablet (source: Medi-Span).
- Wholesale Acquisition Cost (WAC): Slightly lower, around $0.40 to $0.70 per tablet.
Retail Price Analysis:
- Retail prices for branded versions (e.g., Wellbutrin SR) are typically $1.50 to $3.00 per tablet.
- Generic formulations average $0.50 to $1.00 per tablet, reflecting competitive pricing.
Trend Patterns:
- Prices have remained stable since 2015 due to generic competition.
- Slight decreases observed with increased generic penetration.
- Some regional variances exist, with prices higher in rural or underserved areas.
Competitive Landscape
| Product |
Manufacturer |
Pricing |
Market Share |
Notes |
| Bupropion Hydrochloride SR |
Multiple |
~$0.50 |
70-80% of prescriptions |
Dominates due to patent expiry and generics |
| Wellbutrin XL |
GlaxoSmithKline |
Higher at ~$1.50 per tablet |
Used for MDD and SAD |
Branded formulation, less price-sensitive |
| Generic Bupropion SR |
Various |
~$0.50 |
Leading due to affordability |
Growing market presence |
Price Projections (2023–2028)
| Year |
Projected WAC Price per 100 mg Tablet |
Assumptions |
| 2023 |
$0.45 - $0.70 |
Continued generic competition, stable demand |
| 2024 |
$0.45 - $0.65 |
Slight market penetration, potential supply chain adjustments |
| 2025 |
$0.40 - $0.60 |
Price consolidation, emerging biosimilars unlikely |
| 2026 |
$0.40 - $0.55 |
Increased market stability |
| 2027 |
$0.38 - $0.50 |
Marginal price declines expected |
| 2028 |
$0.35 - $0.45 |
Potential price stabilization or slight decrease |
Growth Drivers & Risks
Drivers:
- Growing awareness of depression and mental health issues.
- Policymaker focus on smoking cessation.
- Increasing adoption of generic medications reduces costs and expands access.
Risks:
- New formulations or brands could disrupt pricing.
- Regulatory changes that restrict off-label uses.
- Supply chain issues affecting production costs.
Key Takeaways
- The drug's market relies heavily on generic availability, which caps price increases.
- The current WAC is around $0.50 per 100 mg tablet, with potential for slight decreases over the next five years.
- Market expansion driven by mental health awareness and smoking cessation programs offers potential upside.
- The competitive landscape favors low-cost generics, limiting pricing power for branded versions.
- Long-term prospects depend on regulatory developments and innovation in treatment modalities.
FAQs
1. What factors influence the price of NDC 00378-0757?
Market competition, generic drug penetration, manufacturing costs, and regulatory policies.
2. How does the presence of generics affect market prices?
Generics reduce prices by increasing supply and competition, leading to lower wholesale and retail costs.
3. Are there upcoming regulatory changes that could impact pricing?
No major regulatory shifts are anticipated in the short term, but policy changes toward drug pricing transparency could influence future costs.
4. How does the market demand for this drug compare to other antidepressants?
Demand is stable, with some growth owing to increased mental health awareness but remains lower than newer classes like SNRIs or atypical antipsychotics.
5. What are the main barriers to significant price increases?
Widespread availability of generics, fixed dosing options, and payer control over formulary placement.
Sources
[1] Medi-Span Database, 2023.
[2] IQVIA Prescription Data, 2022–2023.
[3] FDA Drug Approvals & Labeling, 2022.
[4] National Prescription Audit, 2023.
[5] Industry Price Reports, 2023.
