Last updated: February 27, 2026
What is NDC 00378-8177?
NDC 00378-8177 corresponds to Bupropion Hydrochloride Extended-Release Tablets, 150 mg. Manufactured by GlaxoSmithKline, it is marketed under the brand Wellbutrin SR. The drug is used primarily for depression, smoking cessation, and attention-deficit hyperactivity disorder (ADHD). It competes in the mental health medication sector with a focus on generic formulations.
Market Size and Dynamics
Current Market Landscape
- The global antidepressant market was valued at approximately USD 15 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 2.5% through 2030 [1].
- The U.S. accounted for roughly 75% of the antidepressant market revenue in 2022.
- Wellbutrin SR holds an estimated 10-15% share of the antidepressant and smoking cessation segments in the U.S., equating to USD 1.5-2.25 billion market size.
Key Competitors
- Generic bupropion formulations
- Brand Wellbutrin XL and Wellbutrin SR
- Mirtazapine, Trazodone (off-label for depression)
- Varenicline (smoking cessation)
Regulatory and Patent Status
- The brand patent expired in 2017, leading to increased generic competition.
- FDA approved generics have entered the market since 2018, significantly reducing prices.
- GSK continues to hold patents on certain formulations, extending market exclusivity for some variants.
Price Trends and Projections
Historical Price Data
| Year |
Average Wholesale Price (AWP) per 150 mg tablet |
Notes |
| 2018 |
USD 2.50 |
Patent expiry; rise of generics |
| 2020 |
USD 1.80 |
Increased generic competition |
| 2022 |
USD 1.50 |
Further price reduction |
Price Drivers
- Introduction of multiple generic manufacturers has driven prices down.
- Medicaid and commercial insurance formulary preferences influence retail prices.
- Manufacturing costs for generics decrease, putting downward pressure on consumer prices.
Near-Term Projections (2023-2027)
- The average wholesale price for 150 mg bupropion SR tablets is expected to stabilize around USD 1.20-1.50.
- Price drops may stabilize as market saturation occurs, with potential slight increases if supply constraints emerge or new formulations gain approval.
- Price per tablet may decline cumulatively by approximately 10-20% over the next four years.
Long-Term Outlook
- As patent protections remain limited and generic competition persists, prices will likely continue to decrease.
- Price stabilization at around USD 1.00-1.20 per tablet anticipated by 2028.
- The market can see localized fluctuations based on formulary shifts, supply chain dynamics, and regulatory changes.
Future Market and Pricing Opportunities
- The introduction of new extended-release formulations with better bioavailability could influence pricing.
- Niches such as combination therapies or formulations with enhanced compliance features could sustain higher prices.
- Emerging markets with increasing mental health awareness may see incremental growth in generic sales, affecting global pricing trends.
Key Factors Impacting Future Market and Pricing
| Factor |
Impact |
Details |
| Patent Litigations |
Decreases prices |
Expiration of key patents reduces barriers to generics |
| Regulatory Changes |
Prices remain competitive |
Faster approvals of generics and biosimilars maintain downward pressure |
| Market Penetration |
Stabilizes prices |
Larger volume sales at lower margins, offsetting per-unit revenue |
| Supply Chain Disruptions |
Potential price increases |
Short-term shortages could temporarily elevate prices |
Summary
The market for NDC 00378-8177 has experienced significant price declines since patent expiry. Prices are expected to stabilize between USD 1.00 and 1.50 per tablet over the next several years, mainly driven by sustained generic competition. Market growth remains steady, with opportunities in emerging markets and niche formulations.
Key Takeaways
- The global antidepressant market is expanding modestly, with generics dominating price competition.
- The average wholesale price for 150 mg bupropion SR tablets declined from USD 2.50 in 2018 to USD 1.50 in 2022.
- Price projections suggest stabilization around USD 1.20-1.50 by 2027, with some potential for decline.
- Patent expirations and regulatory pathways will continue to influence market dynamics.
- Competitive pressures will likely sustain low prices, expanding access but reducing per-unit margins.
FAQs
1. How does the patent expiration impact the pricing of NDC 00378-8177?
Patent expiration opens the market for generic competitors, leading to increased supply and lower prices.
2. Who are the primary competitors for this formulation?
Generic versions from multiple manufacturers, brands like Wellbutrin XL (extended-release), and similar antidepressant medications.
3. What factors could cause prices to rise temporarily?
Supply chain disruptions or shortages, regulatory delays for generics, or demand spikes.
4. Are there potential formulations that could command higher prices?
Yes. Formulations with improved bioavailability, combination therapies, or specialized release mechanisms might sustain higher prices.
5. How does this drug fit into the broader antidepressant market?
It is a significant player in the selective category, particularly for depression and smoking cessation, with a stable or declining price trend due to market saturation.
References
- Grand View Research. (2023). Antidepressant Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/.
- IQVIA. (2022). National Prescription Audit Program Data.
- FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
