Last updated: February 17, 2026
Overview of NDC 00480-3310
NDC 00480-3310 corresponds to Bupropion Hydrochloride Extended-Release (SR) and Bupropion Hydrochloride Extended-Release (XL) combination in 150 mg/150 mg tablets, marketed by GlaxoSmithKline (GSK). It is prescribed primarily for depression and smoking cessation.
Market Size and Demand Drivers
- Prevalence of depression and smoking cessation: Approximately 17.3 million adults in the U.S. experience at least one major depressive episode annually; nicotine dependence impacts over 34 million adults (CDC, 2022).
- Market penetration: Bupropion ranks among top prescribed antidepressants, with approximately 20 million prescriptions annually in the U.S. (IQVIA, 2022).
- Therapeutic applications: Approved for depression, seasonal affective disorder (as Wellbutrin XL), and smoking cessation (as Zyban). Off-label uses include weight management.
- Competitive landscape: Key competitors include SSRIs (e.g., sertraline, fluoxetine), other atypical antidepressants, and vaping cessation products.
Current Market Participants
| Company |
Product Name |
Market Share |
Estimated Annual Prescriptions (U.S.) |
| GSK |
Wellbutrin XL |
55% |
~11 million |
| Teva |
Bupropion SR |
25% |
~5 million |
| Mylan |
Bupropion IR |
10% |
~2 million |
| Others |
Various generics |
10% |
~2 million |
Pricing Trends
- Brand Name (Wellbutrin XL 150 mg): Average wholesale price (AWP) of ~$350 per 30 tablets.
- Generic equivalents (Bupropion 150 mg ER) vs. Brand: Generics priced at approximately 30-50% of the brand.
Historical Price Developments (last 5 years)
- The price of the brand name medication has remained relatively stable, with expected slight increases (~2-3% annually), coinciding with inflation.
- Generic versions have driven the overall market for Bupropion, reducing the average outpatient prescription cost.
Regulatory & Patent Landscape
- Patent protections for Wellbutrin XL expired in 2017, leading to increased generic competition.
- The FDA approval for Bupropion ER formulations maintains exclusivity for certain indications, but no new patents are expected to delay generic entry.
- Potential biosimilar or new formulations are not currently under development for this NDC.
Market Growth Projections
- The U.S. antidepressant market is projected to grow at a compound annual growth rate (CAGR) of 2-3% through 2027.
- The smoking cessation segment, including Bupropion, is expected to expand at about 1.5-2% CAGR given ongoing public health campaigns.
- Impact of COVID-19: initial decline in prescriptions during 2020 was offset by a rebound in 2021-2022, with increased mental health concerns.
Price Projection (Next 5 Years)
| Year |
Estimated Average Wholesale Price (AWP) per 30 Tablets |
Comments |
| 2023 |
$350 |
Stable, with slight inflationary increase |
| 2024 |
$355 |
Presumed mild increase |
| 2025 |
$360 |
Continuation of trend |
| 2026 |
$365 |
Slight adjustment based on generic competition |
| 2027 |
$370 |
Projected stability, barring significant patent or regulatory changes |
Summary
The market for NDC 00480-3310 remains mature with substantial generic competition, exerting downward pressure on prices. The overall demand will continue modest growth driven by the prevalence of depression and smoking cessation efforts. Price increases remain limited, aligned with inflation and market dynamics.
Key Takeaways
- The U.S. prescription volume for Bupropion ER formulations remains high, with unmet potential in off-label applications.
- The market faces continuous downward pricing pressure due to generic competition following patent expiration.
- Anticipated price stability through 2027, with incremental increases of approximately $5-10 annually for branded options.
- Market growth primarily depends on mental health awareness, public health campaigns on smoking cessation, and continued acceptance of Bupropion's efficacy.
- No immediate bidding for patent extensions or novel formulations is forecasted.
FAQs
-
What factors could impact the price of NDC 00480-3310 in the next five years?
Patent litigation, regulatory changes, or major shifts in therapeutic guidelines could influence prices. Entry of biosimilars or generics beyond current projections might further lower costs.
-
How does generic competition affect market share and pricing?
Generic versions capture approximately 80% of prescriptions, averaging 40-50% lower pricing relative to branded Wellbutrin XL, influencing overall market prices.
-
What is the outlook for biosimilars or alternative formulations?
No biosimilars or novel formulations are currently under development for this specific NDC, limiting market diversification.
-
Are there significant regional variations in pricing and usage?
Yes. Price and prescribing patterns vary considerably by state, driven by formulary preferences and regional health policies.
-
Will new indications impact market value or pricing?
Potential new indications could increase demand but are unlikely to significantly affect pricing without patent protections or exclusive rights.
References
- CDC. "National Center for Health Statistics." 2022.
- IQVIA. "Pharmaceutical Market Overview." 2022.
- FDA. "Drug Approvals and Patent Status." 2022.
- GSK. "Product Monograph." 2022.
