Last updated: August 1, 2025
Introduction
The drug identified by NDC 00480-9435 is Bupropion Hydrochloride Extended-Release (SR), marketed under brand names such as Wellbutrin SR. This medication is widely prescribed for depression, smoking cessation, and off-label uses, positioning it as a significant asset within the psychopharmacology market. Analyzing its current market landscape and projecting future prices necessitates understanding its manufacturing, patent status, competition, regulatory environment, and market demand.
Market Overview
Current Market Landscape
Bupropion SR holds a substantial share in the antidepressant segment, particularly in the off-patent phase, which influences pricing and market dynamics. The drug’s generic version has been widely available since the expiration of key patents around 2012-2014, leading to increased market penetration and price competition [1].
Key Competitors
Generic bupropion SR faces competition from other formulations and brands such as Wellbutrin XL, Zyban (for smoking cessation), and various generic manufacturers. As the patent exclusivities decline, generic competition intensifies, generally exerting downward pressure on prices.
Regulatory Environment
The FDA’s approval of multiple generic equivalents has democratized access but also precipitated price reductions. Current regulatory trends favor biosimilar and generic entry, which influence pricing norms. Given that no recent patent litigations or exclusivity extensions are reported for NDC 00480-9435, the drug remains largely in a competitive generics market.
Market Size and Demand
The US market for bupropion formulations has been estimated at approximately $250 million annually, with sustained demand driven by its efficacy, safety profile, and off-label use cases [2]. The prevalence of depression and smoking cessation programs continues to propel sales, although saturation and the emergence of new pharmacotherapies temper growth projections.
Pharmacoeconomic and Price Trend Analysis
Historical Pricing Data
Post-patent expiration, the average wholesale price (AWP) for a 30-day supply of generic bupropion SR 100 mg tablets declined sharply from roughly $35-$45 to approximately $10-$15 in recent years. Retail price declines aligned with increased generic competition and payer pressure.
Current Pricing Spectrum
Recent data indicates the average retail price for a 30-day supply of NDC 00480-9435, belonging to a generic manufacturer, ranges between $12 and $18, depending on pharmacy and insurance negotiations. Institutional prices and bulk purchasing may further reduce costs.
Price Projection Outlook
Short-term (1-2 Years)
Given the market saturation and the maturity of the generic landscape, expect stable to slightly declining prices. The baseline projection for retail prices remains in the $10-$15 per 30-day supply range, barring significant market disruptions such as drug shortages or formulary shifts.
Medium to Long-term (3-5 Years)
Price erosion is likely to plateau or marginally decline due to ongoing competition, improved manufacturing efficiencies, and healthcare cost containment policies. However, some price stabilization is anticipated as manufacturers optimize supply chains and pursue incremental innovations (e.g., formulation improvements). Potential entry of biosimilar or therapeutic alternatives could further influence prices but currently bear minimal impact on this specific NDC.
Factors Influencing Price Dynamics
- Patent & Exclusivity Status: The absence of current patent protections for this specific NDC supports stable generic competition, preventing significant price hikes.
- Market Penetration & Payer Policies: Payer negotiations favor lower prices and preferred formulary placement, limiting drug price escalation.
- Regulatory Changes: Future regulations incentivizing generics or biosimilars could pressure prices downward.
- Manufacturing Costs: Advances or disruptions in manufacturing technology could influence prices marginally.
Future Market Drivers
- Emerging Alternatives: Development of newer antidepressants or smoking cessation drugs may diminish market share.
- Clinical Guidelines: Changes emphasizing or de-emphasizing bupropion's role could recalibrate demand.
- Patient Access & Insurance Coverage: Payer policies favoring generics reinforce price stability, fostering predictable revenue for manufacturers.
Conclusion
In sum, NDC 00480-9435's market outlook suggests moderate stability in pricing with an overall downward trend aligned with generic drug market characteristics. The key determinants remain the competitive landscape, patent status, and healthcare provider prescribing patterns. Stakeholders should monitor regulatory shifts and competitor activities for nuanced insights into future price movements.
Key Takeaways
- The drug's generic availability has driven prices downward since patent expiry, stabilizing around $10-$15 per month-term supply.
- Market saturation and intense competition forecast minimal price increases; further declines may be limited by manufacturing efficiencies.
- Regulatory policies and payer negotiations play pivotal roles in maintaining current price levels.
- The absence of recent patent protections means the landscape remains highly competitive, curbing substantial price hikes.
- Future innovations or regulatory changes could subtly influence the pricing trajectory but are unlikely to cause significant deviations.
FAQs
1. What factors most significantly influence the price of NDC 00480-9435?
Market competition, patent status, manufacturing costs, payer negotiation policies, and regulatory environment primarily determine current and future pricing.
2. How does patent expiration impact prices for drugs like NDC 00480-9435?
Patent expiration opens the market to generic manufacturers, increasing competition and generally causing drug prices to decline.
3. Are there any upcoming regulatory or patent-related events that could affect this drug’s pricing?
Currently, no notable regulatory or patent events are anticipated to impact NDC 00480-9435; the market remains mature and highly competitive.
4. How does the price of NDC 00480-9435 compare across different pharmacies and insurance plans?
Prices vary based on pharmacy discounts, insurance negotiations, and formulary status, but on average.
5. What are the prospects for price increases for NDC 00480-9435 in the foreseeable future?
Limited potential exists for significant price increases; prices are expected to remain stable or soften slightly due to competition.
References
[1] FDA Patent and Exclusivity Data. U.S. Food and Drug Administration.
[2] Market Research Reports on Bupropion Sales and Demand. IQVIA, 2022.
