Last updated: February 20, 2026
What is the Drug Associated with NDC 50474-0806?
NDC 50474-0806 corresponds to Bupropion Hydrochloride Extended-Release (SR) and Extended-Release (XR) formulations. It is marketed primarily for depression, smoking cessation, and seasonal affective disorder management.
Current Market Landscape
Market Size and Growth
- The global antidepressant market was valued at $17.8 billion in 2022.[1]
- It is projected to grow at a compound annual growth rate (CAGR) of 3% through 2030, driven by increasing mental health awareness and expanding indications.[1]
- Bupropion accounts for approximately 15-20% of the antidepressant market share in the US.[2]
Key Competitors
| Medication |
Formulation |
Estimated US Market Share (2022) |
Indications |
| Wellbutrin XL |
Extended-Release (XR) |
40% |
Depression, smoking cessation |
| Zyban |
Immediate-Release (IR) |
10% |
Smoking cessation |
| Generic Bupropion |
Various formulations |
50% |
Depression, smoking cessation |
Regulatory and Patent Status
- Patent Status: The original patents expired by 2017.
- Market Entry of Generics: Multiple generic versions are available, increasing price competition.
- FDA approvals: The formulation for depression (XR) is approved, with specific labeling for smoking cessation.
Price Analysis
Current Retail and Wholesale Pricing
| Formulation |
Average Wholesale Price (AWP) per unit |
Typical Manufacturer Price |
Estimated Patient Co-pay (Commercial) |
| Bupropion XL 300 mg |
$2.50 per tablet |
$1.80 |
$10-20 per month |
| Generic Bupropion |
$1.50 per tablet |
$1.00 |
$5-15 per month |
Pricing Trends
- Generic Bupropion prices have declined ~20% since 2019 due to increased competition.
- Branded formulations (Wellbutrin XL) retain a premium, typically 2-3 times higher than generics.
- The average retail price for branded versions is approximately $8-$10 per tablet, whereas generics can drop to below $2.
Price Projections
Short-Term (Next 1-2 Years)
- With continued generic penetration, prices are expected to decline further by 10–15%.
- Manufacturer list prices (MLP) for branded formulations may stabilize due to brand loyalty and formulation patents secured on specific delivery mechanisms (e.g., XR).
Long-Term (3-5 Years)
- Potential price stabilization at generic-level pricing, with probable further declines of 10% for generics.
- Market entry of biosimilar-like competition in the future is unlikely due to the nature of small-molecule drugs.
Revenue Projections
| Scenario |
Market Share Assumption |
Estimated Revenue (2023) |
Notes |
| Conservative (generic dominance) |
75-80% generics |
$1.2 billion |
Based on an average price of $1.50 per unit and 250 million units sold |
| Moderate growth |
Market share increase for branded |
$1.5 billion |
Improved market penetration for branded formulations |
Regulatory and Market Considerations
- Patents and Exclusivity: No existing patents protect the current formulations, limiting pricing power.
- Market Dynamics: Price compression due to generics limits profitability.
- Formulation Innovations: Limited expected impact from formulation patents; focus shifts to marketing and biosimilars.
Key Takeaways
- The NDC corresponds to Bupropion extended-release formulations, primarily competing against generics.
- The market is mature with growing prevalence of generics, resulting in price erosion.
- Current prices for branded versions remain significantly higher than generics, but further declines are probable.
- Revenue growth will depend on market share shifts between branded and generic versions.
- Future profitability is constrained by patent expirations and increased competition.
FAQs
What are the primary indications for this drug?
Major depressive disorder, smoking cessation, and seasonal affective disorder.
How competitive is the market for Bupropion?
Highly competitive due to multiple generics, resulting in significant price declines since patent expiry.
What factors could influence future prices?
Market penetration, formulary inclusion, and potential formulation innovations.
Are there any upcoming patent protections or exclusivity periods?
No; patents expired by 2017, opening the market for generics.
What is the outlook for revenue growth?
Limited growth potential due to high generic competition; revenue largely depends on market share retention.
References
[1] Statista. (2022). Global antidepressant market size and forecasts.
[2] IQVIA. (2022). US prescription drug market share analysis.
[3] FDA. (2022). Approved formulations and patent information.
[4] EvaluatePharma. (2022). Market trends in CNS therapeutics.
[5] GoodRx. (2023). Pricing data for Bupropion formulations.
