Last updated: July 27, 2025
Introduction
NDC 00574-0229 corresponds to Bupropion Hydrochloride Extended-Release (SR) and Bupropion Hydrochloride Extended-Release (XL), widely used in the treatment of depression, smoking cessation, and bipolar disorder. As one of the prominent generics of Wellbutrin, this drug has maintained significant market presence due to its efficacy, safety profile, and versatile application. This analysis evaluates the current market landscape, competitive dynamics, remaining patent considerations, and provides forecasted pricing trends, equipping stakeholders with strategic insights.
Market Overview and Demand Dynamics
1. Indications and Clinical Adoption
Bupropion's core indications encompass depression (MDD), seasonal affective disorder, smoking cessation, and bipolar disorder. Its favorable side effect profile—particularly reduced sexual dysfunction risk compared to SSRIs—has bolstered clinician preference in both psychiatric and primary care settings ([1]).
2. Market Penetration and Steady Demand
The drug's broad therapeutic use sustains consistent demand. According to IQVIA data, Bupropion accounted for approximately $1.4 billion in U.S. prescription sales in 2022, with sustained growth driven by expanded this year through increased awareness and off-label uses ([2]).
3. Competitors and Market Share
While the original formulation was branded (Wellbutrin), multiple generics have entered the market, notably Mylan, Teva, and Apotex. The extensive presence of generics has led to pricing reductions, yet the drug retains a significant market share.
New formulations—such as sustained-release (SR/XL) variants—compete with immediate-release formulations, with user preference generally driven by convenience and tolerability considerations.
Regulatory and Patent Landscape
1. Patent Expiry and Market Entry
The primary patents protecting the drug’s formulation expired by 2012, facilitating broad generic entry. However, certain secondary patents, especially pertaining to specific formulations or delivery mechanisms, have extended market exclusivity in some regions through litigation or patent term extensions ([3]).
2. Patent Litigation and Exclusivity Status
Recent patent litigations have been largely resolved, allowing generics to dominate the market with minimal legal barriers. As of 2023, no significant patent restrictions impede generic proliferation, supporting continued price competition.
Pricing Trends and Projections
1. Historical Price Trends
Since generic entry, prices for NDC 00574-0229 have decreased sharply. As of early 2023, the average wholesale acquisition cost (WAC) for a 30-day supply ranged from $25 to $40, with retail prices often lower due to discounts and insurance negotiations ([4]).
2. Factors Influencing Future Prices
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Market Competition: As more generics enter, price erosion is expected to persist, stabilizing eventually.
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Manufacturing Costs: Advances in manufacturing and scale economies reduce costs, facilitating price reduction.
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Regulatory Environment: Potential exclusivity extensions or patent disputes could temporarily stabilize prices but are unlikely to halt downward trends in the long term.
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Supply Chain Dynamics: Global supply chain stability, especially post-pandemic, influences drug availability and pricing. Shortages could temporarily inflate prices.
3. Price Projection (Next 3–5 Years)
Based on current trends and market mechanics:
- 2023-2024: Stable prices at approximately $20–$35 per 30-day supply, with slight decreases driven by market saturation.
- 2025-2027: Prices are projected to decline modestly, reaching $15–$25 per 30-day supply**, as additional competitors enter and manufacturing efficiencies improve.
- Long-term outlook: Prices could stabilize around $10–$20 per 30-day supply**, assuming no significant patent defenses or regulatory interventions.
Market Opportunities and Risks
Opportunities
- Extended-Release Formulations: Growing preference for once-daily dosing favors sustained-release formulations, potentially commanding premium pricing.
- Pharmacoeconomic Appeal: Lower-cost generics align with increasing demand for affordable mental health medications.
- Global Markets: Expansion into emerging markets with increasing mental health awareness could boost sales.
Risks
- Market Saturation: Intense generic competition may lead to further price reductions.
- Regulatory Hurdles: New formulation patents or exclusivities could temporarily impede pricing strategies.
- Off-label and New Therapies: Emerging drugs with better efficacy profiles or fewer side effects could erode market share.
Strategic Implications for Stakeholders
- Manufacturers should focus on optimizing production costs and explore value-added formulations (e.g., extended-release variants) to command price premiums.
- Payers and Providers can leverage the declining price trends for cost-effective treatment options.
- Investors should monitor patent landscapes and regulatory developments that may influence pricing and market share.
Key Takeaways
- The market for NDC 00574-0229 (Bupropion XL/SR) remains robust, supported by steady demand, broad indications, and a matured patent landscape favoring generics.
- Price erosion has been significant post-patent expiration; future trends suggest continued moderate declines, with prices stabilizing at lower levels over the next 3–5 years.
- Market growth potential exists in global emerging markets and through formulation innovations, though competition remains fierce.
- Stakeholders should maintain vigilance regarding patent status, regulatory changes, and evolving clinical preferences to optimize strategic positioning.
FAQs
Q1: Will the price of NDC 00574-0229 continue to decrease in the coming years?
A1: Yes. Market saturation, increased generic competition, and manufacturing efficiencies support ongoing price reductions, although at a moderated pace.
Q2: Are there any patent protections still influencing the pricing of this drug?
A2: As of 2023, primary patents have expired, allowing broad generic entry. Secondary patents are unlikely to substantially impact pricing unless renewed or contested.
Q3: How does the market for Bupropion differ internationally?
A3: In emerging markets, pricing tends to be higher due to supply chain factors and less competition, though generic penetration is increasing globally.
Q4: What future formulation developments could impact pricing?
A4: Innovations such as once-daily extended-release formulations or combination therapies could command premium pricing but are subject to patent and regulatory considerations.
Q5: How do supply chain disruptions influence the price of NDC 00574-0229?
A5: Disruptions can temporarily inflate prices due to shortages; however, over the long term, competitive market forces tend to offset these effects.
References
- Fountoulakis, K. N., et al. (2021). Updates in the pharmacological management of depression. Psychiatry Research, 295, 113560.
- IQVIA. (2023). 2022 Prescription Drug Market Data.
- U.S. Patent and Trademark Office. (2013). Patent expiration details for Bupropion formulations.
- SSR Health. (2023). ADJ: Average Wholesale Prices and Market Trends.
