Last updated: August 2, 2025
Introduction
The drug identified by the National Drug Code (NDC) 00777-3104 is Bupropion Hydrochloride Extended-Release (SR), a generic pharmaceutical typically prescribed for depression, smoking cessation, and certain psychiatric disorders. Understanding its market landscape involves analyzing the current demand, competitive dynamics, regulatory environment, pricing trends, and future projections.
This report provides a comprehensive analysis of the market and delivers price projections for NDC 00777-3104, supporting stakeholders in strategic decision-making.
Market Overview
Product Description and Therapeutic Area
Bupropion SR is a widely prescribed atypical antidepressant and smoking cessation aid. It modulates neurotransmitter activity, primarily affecting dopamine and norepinephrine pathways. Its favorable side effect profile compared to older antidepressants has driven sustained demand.
Market Size and Demand
The global antidepressant market, valued at approximately $15 billion in 2022, exhibits steady compound annual growth (CAGR) of about 2-4%, driven by increasing mental health awareness and expanding indications[[1]]. Bupropion constitutes an estimated 20-25% of this market segment, with consistent annual sales globally, particularly in the United States, which accounts for approximately 75% of demand due to high prescription rates and insurance coverage.
Key Market Drivers
- Rising mental health disorder prevalence.
- Increased awareness of smoking cessation products.
- Favorable side effect profile over alternatives.
- Patent expiration of branded versions, fostering generic entry.
Competitive Landscape
The generic Bupropion SR market is highly permeated, with major players including Mylan (now Viatris), Teva, Sandoz, and others. Price competition and formulary preferences significantly influence sales volume and gross margins. Brand-name versions like Wellbutrin XL continue to retain a share driven by physician preference and patient familiarity, though generics dominate due to lower cost.
Regulatory and Patent Analysis
Patent Status
The initial branded patent for Wellbutrin XL expired around 2012. Since then, multiple generic manufacturers, including the maker of NDC 00777-3104, have entered the market. Patent cliffs have catalyzed increased generic penetration, impacting pricing and market share.
Regulatory Considerations
The FDA’s approval of Abbreviated New Drug Applications (ANDAs) has facilitated rapid generic entry. The manufacturing and quality compliance for NDC 00777-3104 align with regulatory standards, supporting widespread market acceptance.
Pricing Trends and Historical Data
Current Market Prices
As of late 2022, retail prices for a typical 30-count 100 mg Bupropion SR tablet can fluctuate between $10 and $25, depending on the pharmacy and insurance coverage. The wholesale acquisition cost (WAC) averaged around $0.50 - $0.70 per tablet for generics.
Price Dynamics
Generic Bupropion SR prices tend to decrease post-patent expiry due to competition. Notably, the price for NDC 00777-3104 aligns with these trends, with recent reductions of approximately 10-15% year-over-year, driven by increased market entrants and formulary negotiations.
Market Share and Distribution Channels
Distribution Factors
- Formulary Positioning: Insurance formulary inclusion significantly affects prescription volumes.
- Generics Conversion: The shift in prescriber and patient preferences towards generics further amplifies distribution.
- Dispensing Trends: Clinical guidelines and physician familiarity sustain steady prescriptions despite competitive pressures.
Distribution Channels
- Pharmacies (retail and mail-order) dominate.
- Hospital and institutional dispensing are niche but relevant for specific patient populations.
- Online pharmacies are emerging, influenced by lower prices and convenience.
Price Projections (2023–2028)
Projection Methodology
Price forecasts are based on historical data, market competition intensity, regulatory factors, and macroeconomic influences on pharmaceutical procurement. Conservative estimates account for saturated competition and price erosion tendencies.
Forecast Summary
| Year |
Projected Price Range per 30-Count, 100 mg Tablets |
Assumptions |
| 2023 |
$8 - $15 |
Continued competition; margins decreasing |
| 2024 |
$7 - $14 |
Increased market saturation |
| 2025 |
$6 - $13 |
Price stabilization amid new entrants |
| 2026 |
$6 - $12 |
Market maturity; slower declines |
| 2027 |
$5.50 - $11.50 |
Marginal price compression |
| 2028 |
$5 - $11 |
Reach of minimum sustainable margins |
Note: Prices could be influenced by external factors, including regulatory reforms, patent-related litigations, or large-scale market exits.
Key Market Opportunities and Risks
-
Opportunities:
- Expansion into emerging markets.
- Development of combination therapies.
- Strategic pricing to increase market share.
-
Risks:
- Price erosion due to intense generic competition.
- Changes in prescribing guidelines favoring alternative therapies.
- Regulatory shifts impacting manufacturing costs or approval processes.
Conclusion
The market for NDC 00777-3104—a generic Bupropion Hydrochloride Extended-Release formulation—is mature with robust demand driven by prescription patterns, brand-to-generic substitution, and expanding indications. Price erosion is ongoing but stabilizes as the market matures, with projections indicating slight declines over the next five years.
While overall profitability may diminish due to aggressive competition, the product remains essential in depression and smoking cessation therapy portfolios. Strategic positioning, including optimizing manufacturing efficiency and expanding distribution, can sustain margins.
Key Takeaways
- The global demand for Bupropion SR remains stable, with the U.S. leading consumption.
- Generic competition has driven prices downward, with projections indicating continued modest declines.
- Price stability could be supported through formulary negotiations and expanding indications.
- Regulatory and patent considerations significantly influence market dynamics.
- Stakeholders should monitor competitive entries and policy shifts to adapt pricing strategies effectively.
Frequently Asked Questions
1. What factors influence the pricing of generic Bupropion SR (NDC 00777-3104)?
Pricing is primarily affected by competition levels, manufacturing costs, procurement channels, formulary negotiations, and regulatory environment.
2. How does the patent expiration of branded Bupropion drugs impact the market?
Patent expiration facilitates generic market entry, increasing supply, intensifying price competition, and leading to decreased prices for both generic and branded versions.
3. What are the primary markets for NDC 00777-3104?
The United States is the dominant market, with additional opportunities in Europe, Canada, and select Asian countries, contingent on regulatory approvals.
4. Are there upcoming regulatory changes that could affect prices?
Possible reforms focusing on drug pricing transparency and importation could influence market dynamics, but currently, no imminent regulation is forecasted to drastically alter prices.
5. What strategic moves can generic manufacturers adopt to maintain profitability?
Optimizing manufacturing efficiencies, diversifying distribution channels, fostering formulary inclusion, and innovating through combination therapies can help sustain margins amid price compression.
References
[1] IQVIA. (2022). Market Analysis of the Global Antidepressant Market.
[2] FDA. (2021). ANDA Approvals and Patent Status.
[3] Pharma Intelligence. (2022). Generic Bupropion Market Trends.
[4] GoodRx. (2023). Current Pricing Data for Bupropion SR.
[5] World Health Organization. (2021). Mental Health Disorders and Medication Trends.
