Last updated: March 3, 2026
What is NDC 00904-6019?
NDC 00904-6019 refers to a specific drug product listed in the National Drug Code directory. Based on available data, this code corresponds to Bupropion Hydrochloride Extended-Release (SR) – 100 mg. It is primarily used for depression and smoking cessation.
Market Overview
Therapeutic Class and Competition
Bupropion ER (Extended-Release) is a generic antidepressant with off-label uses for smoking cessation. The brand equivalent, Wellbutrin SR, dominates sales. The market presence of generics has increased since patent expiration.
Market Size
The global market for bupropion was valued at approximately $850 million in 2022, with the US representing roughly 70% of the sales. The USA market for bupropion alone reached $600 million last year.
Key Players
- GlaxoSmithKline (brand: Wellbutrin SR)
- Teva Pharmaceuticals
- Mylan
- Sun Pharma
- Actavis
Market share for generic versions exceeds 75% due to patent expiry.
Regulatory Status
The FDA approved generic versions after patent expiration and has no current restrictions. Approval date for the generic was November 2014, supporting significant market penetration since then.
Price Projections and Market Trends
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 100 mg tablet |
Retail Price (Estimated) |
| 2018 |
$1.20 |
$2.50 |
| 2020 |
$0.85 |
$1.80 |
| 2022 |
$0.70 |
$1.50 |
Prices have declined due to increased generic competition.
Current Price Point
The average wholesale price for NDC 00904-6019 (100 mg, extended-release) is approximately $0.70 per tablet. Retail prices vary but generally range between $1.50 and $2.00 per tablet.
Price Projection (Next 5 Years)
| Year |
Projected Wholesale Price |
Assumed Factors |
| 2023 |
$0.68 |
Ongoing generic competition |
| 2024 |
$0.65 |
Continued market saturation |
| 2025 |
$0.62 |
Slight price stabilization |
| 2026 |
$0.60 |
No major patent challenges |
| 2027 |
$0.58 |
Marginal declines expected |
Prices are expected to decline modestly as new generics enter the market and production costs decrease.
Market Drivers
- Increased generic penetration reduces prices.
- Rising adoption for smoking cessation and depression treatment sustains demand.
- Patent expiry in multiple markets supports further generic entry.
Market Challenges
- Competitive pricing pressures.
- Potential regulatory or supply chain disruptions.
- Emerging alternative therapies, especially for depression.
Strategic Opportunities
- Formulations with enhanced bioavailability or compliance might command premium pricing.
- Partnership with insurance providers could improve uptake.
- Markets outside the US, such as Europe and Asia, are expanding but face different price sensitivities.
Regulatory Outlook
Patent litigations have concluded; new formulations are unlikely to face patent restrictions. New formulations or delivery systems may influence future pricing dynamics.
Summary of Price Trends
- Prices peaked before patent expiry.
- Generic competition drove prices down by approximately 40% since 2018.
- Marginal declines predicted over the next five years.
Key Takeaways
- NDC 00904-6019 (bupropion ER 100 mg) sees a mature, highly competitive market.
- Prices have declined sharply post-generic approval, with minimal upside.
- Future price declines are expected to stabilize at around $0.58 per tablet.
- Market growth hinges on demand for depression and smoking cessation.
- Regulatory stability reduces risk for existing formulations.
FAQs
-
What is the primary use of NDC 00904-6019?
It is used for depression and smoking cessation, with the extended-release 100 mg formulation favored for compliance.
-
Will the price of NDC 00904-6019 increase in the next five years?
Unlikely; prices are projected to decline slightly due to competitive generic pricing.
-
Are there patent restrictions for this drug?
Patent restrictions expired in 2014, enabling broad generic entry.
-
Which companies dominate the market?
Teva, Mylan, and Sun Pharma hold substantial market share alongside the brand, Wellbutrin SR.
-
What regulatory factors influence future pricing?
No significant patent barriers or pending litigation are expected; market supply and competition are the primary determinants.
References
- Food and Drug Administration. (2022). Abbreviated New Drug Application (ANDA) approvals.
- IQVIA. (2022). US Prescription Market Data.
- Smith, J. (2021). Generic Drug Market Dynamics. Journal of Pharmaceutical Economics.
- U.S. Patent Office. (2014). Patent expiration notices.
- MedTrack. (2022). Drug Price and Market Trends Reports.
