Last updated: February 25, 2026
What Is NDC 54738-0102?
NDC 54738-0102 refers to a specific drug product listed in the National Drug Code (NDC) database. It corresponds to Bupropion Hydrochloride Extended-Release (SR) 100 mg, marketed primarily for depression and smoking cessation.
Market Overview
Product Lifecycle and Indications
- Indications: Major depressive disorder, seasonal affective disorder, smoking cessation.
- Formulation: Extended-release tablets, 100 mg dosage.
- Manufacturer: Usually marketed by multiple generic manufacturers following patent expiry of the original brand ZYBAN (GlaxoSmithKline).
Competitive Landscape
- Market Players: Generic competitors dominate, including Teva, Mylan, Lupin, amongst others.
- Brand Market Share: ZYBAN held initial patent protection until around 2012; generics now hold over 85% of prescriptions.
- Market Size: In the U.S., about 3 million prescriptions annually, worth approximately $400 million (IQVIA, 2022).
Regulatory Status
- FDA approval for generics since around 2013.
- No current patent exclusivities for the generic version.
Price Trends and Projections
Current Pricing Dynamics
| Metric |
Data |
| Average Wholesale Price (AWP) per 30-count bottle (100 mg) |
$130 - $150 |
| Typical Medicaid Reimbursement Price |
$50 - $70 |
| Common Medicaid Dispensing Fee |
~$9 per prescription |
Historical Price Changes
- Post-generic entry (2013), prices dropped by approximately 20-30%.
- Since 2018, prices stabilized with minor fluctuations.
- Recent trends show slight increases due to supply chain issues, with average prices rising by 3-5% annually.
Forecast for 2023-2027
- Price Stability: Prices are expected to hold with minimal change, considering no new patent protections or formulary shifts.
- Influencing Factors:
- Potential market entry of biosimilars or new formulations.
- Changes in insurance policies or reimbursement rates.
- Supply chain disruptions or raw material cost increases.
Global Market Outlook
- U.S. dominates sales; European and Asian markets are smaller.
- Price patterns follow similar generic market trends, with local variations due to regulatory environments.
Pricing Strategies and Economic Incentives
- Manufacturers focus on volume sales given narrow margins per unit.
- Discounts and rebates are common, especially for government programs.
- Potential for formulary exclusions or preferred status affecting retail pricing.
Implications for Stakeholders
- Manufacturers: Maintain competitive pricing; innovate with combination therapies or extended-release versions.
- Distributors: Rely on volume; supply chain reliability impacts pricing.
- Healthcare Providers: Prescribe based on approved indications and formulary status.
- Payers: Monitor drug utilization and negotiate rebates.
Key Takeaways
- NDC 54738-0102 represents a generic form of bupropion SR (100 mg).
- Market competition has driven prices downward since patent expiry.
- Prices are expected to remain relatively stable over the next five years barring supply disruptions or policy changes.
- The drug's positioning in depression and smoking cessation markets sustains demand volume.
- Stakeholders should watch for regulatory or market developments that could influence pricing dynamics.
FAQs
1. How has the entry of generics impacted pricing for NDC 54738-0102?
Prices decreased by approximately 20-30% following generic approval in 2013 due to increased competition.
2. What factors could cause prices to increase in the future?
Supply chain issues, raw material cost increases, or policy changes affecting reimbursement could prompt upward price adjustments.
3. Are there patent protections still linked to this drug?
No. The original patent expired around 2012, allowing generics to dominate the market.
4. How does the market size compare between the U.S. and abroad?
The U.S. accounts for the majority of sales, with smaller volumes in Europe and Asia, following similar generic pricing trends.
5. What is the potential for new formulations or combination therapies?
Limited at present; most focus remains on maintaining volume with existing formulations, though innovation could shift the market.
Sources
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2013). Approval history of generic bupropion products.
- Medi-Span. (2022). Pricing and formulary data.
- National Drug Code Directory. (2022). Database entries for NDCs.
