Last updated: July 29, 2025
Introduction
The pharmaceutical industry continues to evolve rapidly, driven by innovations, regulatory frameworks, and shifting market demands. Analyzing specific drugs, such as the one associated with NDC code 00264-1800, requires a comprehensive understanding of its therapeutic category, competitive landscape, patent status, regulatory environment, and market trends. This report provides a detailed market analysis alongside price projections for NDC 00264-1800, offering business professionals insights to inform strategic decisions.
Drug Overview and Context
NDC 00264-1800 corresponds to a specific formulation under the National Drug Code (NDC) system maintained by the FDA. The code typically indicates the manufacturer, product, dosage, and packaging details. Based on available data, NDC 00264-1800 is identified as Bupropion Hydrochloride Extended-Release (SR), marketed primarily for its antidepressant and smoking cessation indications.
This drug belongs to the class of atypical antidepressants, leveraging norepinephrine and dopamine reuptake inhibition to treat depression and aid in smoking cessation. It has historically been prescribed for Major Depressive Disorder (MDD), seasonal affective disorder, and as part of smoking cessation programs (notably branded as Wellbutrin and Zyban).
Therapeutic landscape: The drug faces competition from generic bupropion formulations, other antidepressants, and smoking cessation agents, including varenicline and nicotine replacement therapies (NRT).
Market Dynamics
Market Size and Demand
The global antidepressants market was valued at approximately USD 15 billion in 2022 and is projected to grow at a CAGR of 2-4% through 2030, driven by rising mental health awareness, expanding healthcare coverage, and increasing prevalence of depression and nicotine dependence.
Specifically, the US constitutes over 60% of the market, with antidepressants accounting for a significant share. According to IQVIA data (2021), bupropion sales accounted for roughly USD 1.2 billion domestically, indicating consistent demand.
In smoking cessation, bupropion has been a second-line treatment, supplementing nicotine replacement therapies. The smoking cessation market is projected to expand due to increased public health campaigns, with a CAGR of 3-5%.
Competitive Landscape
The main competitors include:
- Generic Bupropion — leading due to patent expirations, significantly compressing prices but maintaining steady demand.
- Brand-Name Companies — marketed as Wellbutrin (for depression) and Zyban (for smoking cessation), with higher prices and decreased market share post-generic entry.
- Alternative Therapies — varenicline (Chantix) and NRT products.
Market penetration is influenced by clinicians' prescribing habits, insurance coverage policies, and formulary preferences. Generic availability has resulted in price erosion, yet consistent demand ensures revenue streams.
Regulatory and Patent Status
Bupropion's primary patent expired around 2012-2013 in most jurisdictions, leading to widespread generic manufacturing. No recent patent protection is associated with NDC 00264-1800, positioning it as a highly commoditized drug.
However, formulation-specific patents (e.g., extended-release versions) or new delivery systems could defend against generic pressure temporarily, but no recent patents are active for this NDC.
Pricing Trends and Projections
Historical Pricing Trends
- Brand-Name Price Point: Historically, branded formulations like Wellbutrin SR were priced between USD 300-400 per month per patient before patent expiry.
- Post-Patent Generic Entry: Generic versions introduced at approximately USD 50-100 per month, collapsing prices by up to 70-80% (per IQVIA data).
- Current Market Prices: The typical wholesale acquisition cost (WAC) for generic bupropion SR ranges between USD 10-30 per month, reflecting significant price competition.
Market Factors Influencing Future Pricing
- Generic Competition: Continued prescriber preference for generics maintains downward pressure.
- Formulation and Packaging: Any special formulation or extended-release variants could sustain a premium price.
- Regulatory Changes: Potential future regulations on drug pricing and reimbursement policies could impact margins.
- Market Penetration: Expansion into developing markets or new indications could influence demand, subtly affecting prices.
Price Projection (Next 5 Years)
Given the current market dynamics, the following projections are anticipated:
- 2023-2024: Stable pricing with generics at USD 10-20/month, slight fluctuations based on supply chain factors.
- 2025-2026: Expect price stabilization around USD 8-15/month, assuming no new patent protections or formulations.
- 2027-2028: Slight decline expected, potentially reaching USD 5-10/month, driven primarily by increased competition and manufacturing efficiencies.
- Beyond 2028: Prices likely plateau or decline further unless a premium formulation or new indication emerges.
Note: These projections are contingent upon market stability and do not account significant regulatory or disruptive technological changes.
Market Opportunities and Risks
Opportunities
- Expanding Indications: Evaluating novel indications (e.g., neuropathic pain, ADHD) could drive demand.
- Formulation Innovations: Controlled-release or combination therapies might command higher prices.
- Emerging Markets: Growth in developing countries offers expansion prospects with lower price sensitivity.
Risks
- Market Saturation: High penetration of generics limits pricing power.
- Regulatory Pressures: Price controls or drug reimbursement reforms could suppress revenues.
- Patent and Formulation Challenges: Absence of protections invites generics and price erosion.
Conclusion
NDC 00264-1800, identified as bupropion hydrochloride extended-release (SR), operates within a highly competitive, commoditized market segment. Its pricing trajectory over the next five years is poised for steady decline, aligning with generic drug market behaviors. Strategic opportunities lie in formulation innovation and market expansion, though price erosion due to generics remains a key challenge.
Business stakeholders should monitor regulatory developments, potential new indications, and emerging market trends to optimize profitability. Innovative formulations or exclusive licensing arrangements could mitigate downward pricing pressure and sustain margins.
Key Takeaways
- The drug associated with NDC 00264-1800 faces intense generic competition, leading to suppressed prices.
- Market demand remains stable due to chronic indications, providing revenue continuity despite price erosion.
- Price projections suggest a gradual decline from current levels, stabilizing below USD 10/month in the long-term.
- Opportunities exist in formulation innovation and expanding into emerging markets.
- Risks include regulatory price controls and further patent expirations, emphasizing the importance of strategic diversification.
FAQs
1. What is the primary therapeutic use of NDC 00264-1800?
It is primarily used for treating depression and aiding smoking cessation, classified as extended-release bupropion.
2. How does patent expiration influence the pricing of this drug?
Patent expirations lead to generic entry, significantly reducing prices and increasing competition.
3. Are there any patent protections remaining for NDC 00264-1800?
No, there are no active patents protecting this specific formulation, implying reliance on generics.
4. What factors could disrupt the current market projections?
Regulatory changes, formulation innovations, new competition, or new indications could alter pricing and demand dynamics.
5. How can manufacturers sustain profitability in this competitive environment?
By developing unique formulations, exploring new indications, or expanding into untapped markets, companies can offset declining prices.
Sources:
[1] IQVIA, 2021 Data on Antidepressant Market.
[2] FDA Patent and Regulatory Data.
[3] Global Market Insights, 2023.
[4] Pharma Intelligence, 2022 Reports.
