Last updated: March 1, 2026
What is NDC 51407-0331?
NDC 51407-0331 refers to a medication marketed as Bupropion Hydrochloride Extended-Release, 300 mg. Bupropion is an antidepressant also used for smoking cessation. It is sold under brand names like Wellbutrin XL and marketed as a generic by multiple manufacturers.
Market Size and Key Drivers
U.S. Market Overview
- Market Volume: Estimated at approximately 20 million prescriptions annually (IQVIA, 2022).
- Patient Base: Majorly prescribed for depression, smoking cessation, and ADHD.
- Growth Factors:
- Increasing awareness about mental health.
- Expansion of off-label uses.
- Growing generic penetration reducing costs.
Competitive Landscape
Regulatory Status
- Approval: Approved by FDA for depression and smoking cessation.
- Patent Status: Patent expiration in 2017, leading to generics dominance.
Pricing Dynamics and Projections
Current Price Range
| Formulation |
Approximate Wholesale Acquisition Cost (WAC) per 30-day supply |
| Brand (Wellbutrin XL 300 mg) |
$650 - $700 |
| Generic (Bupropion XL 300 mg) |
$60 - $80 |
Historical and Projected Trends
- Price Drop Post-Patent Expiry: 2017 saw a 90% reduction in generic prices.
- Current Trends: Prices have stabilized in the last two years with slight fluctuations due to manufacturing shifts and supply chain dynamics.
Future Price Projections (Next 3 Years)
| Year |
Expected Average Price (per 30-day supply) |
Notes |
| 2023 |
$75 |
Stable, with minor fluctuations |
| 2024 |
$70 - $75 |
Increased competition, supply stabilization |
| 2025 |
$70 |
No significant change expected |
Influencing Factors
- Supply Chain Disruptions: Post-Pandemic recovery may influence costs.
- Generic Competition: Increased market entries may further lower prices.
- Regulatory Changes: Policy shifts could impact pricing, especially if biosimilar or alternative formulations emerge.
Market Entry and Investment Opportunities
- High-volume generic manufacturing remains profitable due to large prescribing base.
- Potential for biosimilars or newer formulations targeting specific patient needs could create premium pricing.
- Price sensitivity limits the profitability of branded formulations, pushing a focus onto generics.
Key Regulatory and Policy Considerations
- Pricing regulations vary by state; some states enforce price caps.
- Trade agreements could influence import/export dynamics affecting supply and pricing.
- FDA policies favor rapid approval of generics, increasing market competition.
Summary
The market for NDC 51407-0331, comprising generic Bupropion Hydrochloride Extended-Release 300 mg, remains mature. Significant price decreases occurred following patent expiry in 2017, with now stable low-cost generics dominating. Price projections indicate limited upward movement over the next three years due to entrenched competition, supply chain considerations, and regulatory pressures.
Key Takeaways
- Market volume remains high, driven by broad indications and demand.
- Generic prices have stabilized around $70-$75 per 30-day supply.
- Future market growth hinges on new formulations and regulatory shifts.
- Competition continues to suppress prices, making profit margins narrow for branded versions.
- Import/export policies and supply chain factors will influence supply and prices.
FAQs
1. What are the main therapeutic uses for NDC 51407-0331?
Treats depression, aids smoking cessation, and off-label uses like ADHD.
2. Are there patent protections still in place?
No. Patent expired in 2017, allowing generic manufacturers to compete.
3. How does the price compare between brand and generic?
Generics cost approximately 10% of the branded product, typically $60-$80 versus $650-$700.
4. What factors could alter future prices?
Supply chain disruptions, regulatory changes, and new market entrants.
5. Is there emerging competition for this formulation?
Yes, biosimilars or new delivery methods may impact pricing and market share in the future.
References
- IQVIA. (2022). Medicine Use and Spending in the U.S.. [Data set].
- U.S. Food and Drug Administration (FDA). (2017). Patent and exclusivity information.
- GoodRx. (2023). Average retail prices for Bupropion XL 300 mg.
- IMS Health (2021). Prescription Trends for Antidepressants.
- MarketWatch. (2023). Price trends in generic pharmaceuticals.
