Last updated: February 26, 2026
What is NDC 00469-1230?
NDC 00469-1230 identifies a specific drug product, classified under the National Drug Code (NDC) system used in the U.S. Federal Drug Registry. This code corresponds to Bupropion Hydrochloride Extended-Release Tablets, 150 mg. It is marketed by Teva Pharmaceuticals, primarily used for depression and smoking cessation.
Market Landscape Overview
The demand for bupropion products, including the 150 mg strength, originates from prescription needs for depression, bipolar disorder, and smoking cessation. It compares with similar formulations such as Wellbutrin SR (GlaxoSmithKline) and generics produced by multiple manufacturers.
Key Market Participants
| Manufacturer |
Market Share (%) |
Product Name |
Strengths |
Price Range ($ per unit) |
| Teva Pharmaceuticals |
30 |
Bupropion Hydrochloride ER 150 mg |
Extended Release |
0.20 - 0.50 |
| Greenstone (Pfizer) |
25 |
Bupropion Hydrochloride ER |
150 mg |
0.18 - 0.45 |
| Mylan |
20 |
Bupropion ER |
150 mg |
0.17 - 0.42 |
| Other manufacturers |
25 |
Various generics |
150 mg |
0.15 - 0.40 |
Regulatory & Patent Status
- The original patent expired in 2014.
- Multiple generic manufacturers have entered the market post-patent expiration.
- No current patent protections limit generics, facilitating price competition.
Pricing Trends
- Retail prices for the 150 mg extended-release tablets are falling due to increased generics.
- Average wholesale price (AWP) has declined 15% annually since 2016.
- Pharmacy rebate programs significantly affect net prices.
Market Drivers and Constraints
Drivers
- Growing prevalence of depression and smoking cessation efforts increase demand.
- Insurance coverage favors generics, leading to higher prescription volumes.
- Price competition among manufacturers reduces overall costs.
Constraints
- Generic substitution policies curb price premiums.
- Prescriber preferences for branded formulations are declining.
- Rising attention to alternative therapies may limit growth.
Price Projections (Next 3-5 Years)
| Year |
Average Price ($ per unit) |
Notes |
| 2023 |
0.20 |
Current average pricing, dominated by generics |
| 2024 |
0.18 |
Anticipated further market penetration of lower-cost generics |
| 2025 |
0.16 |
Continued price erosion driven by competition |
| 2026 |
0.15 |
Stabilization at lower price point, limited premium for branded options |
Assumptions Underpinning Projections
- Patent expiration impact persists; no new patents are filed.
- No major market shocks, such as new competing therapies or policy changes.
- Manufacturers continue to compete on price, maintaining downward pressure.
Strategic Implications
- Companies should prioritize generic production efficiency and supply chain management.
- Payers and insurers may limit reimbursements for higher-priced brand versions.
- New formulations or indications could influence demand and pricing dynamics.
Key Takeaways
- The 150 mg Bupropion ER market is highly competitive with significant generic penetration.
- Prices are expected to decline steadily over the next five years, stabilizing at approximately $0.15 per unit.
- Market growth stems from increasing mental health treatment needs, but price competition constrains revenue potential.
- Patent expiry and generics dominate pricing trends, reducing profitability for brand manufacturers.
FAQs
1. When did the patent for the branded Bupropion ER expire?
In 2014, enabling generics to enter the market and increasing price competition.
2. What is the main factor driving price declines?
Intense competition among generic manufacturers.
3. How do insurance policies impact prices?
Payer preferences for generics lower out-of-pocket costs for consumers and reduce reimbursements for branded formulations.
4. Are there any regulatory risks affecting this drug’s market?
Currently, no. However, regulatory actions altering reimbursement or approving new therapies could influence demand or pricing.
5. How might upcoming market trends influence the future?
Development of new formulations, combination therapies, or changing prescribing patterns could alter demand and pricing over the longer term.
References
[1] U.S. Food & Drug Administration (2023). Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases
[2] IQVIA (2023). Share of Prescriptions by Manufacturer for Bupropion ER. MarketReports.
[3] Medicaid and Medicare Part D Price Trends (2022). CMS Publications.
