Last updated: February 19, 2026
What Is NDC 00054-0284?
NDC 00054-0284 corresponds to Bupropion Hydrochloride Extended-Release (SR) and Bupropion Hydrochloride Extended-Release (XL) Tablets. marketed under the brand name Wellbutrin SR and Wellbutrin XL, primarily used for depression and smoking cessation support. It is available through multiple generic manufacturers as well.
Market Size and Trends
Current Market Overview
- U.S. prescriptions for bupropion formulations reached approximately 27 million annually, per IQVIA data (2022).
- The drug holds a significant share in the antidepressant segment, especially among generic formulations.
- Market penetration into smoking cessation is increasing due to FDA approval of Wellbutrin as an aid.
Competitive Landscape
| Product Type |
Market Share (2022) |
Price Range (per tablet) |
Key Manufacturers |
| Brand (Wellbutrin) |
~30% |
$2.00 - $4.00 |
GlaxoSmithKline (GSK), Valeant |
| Generics |
~70% |
$0.60 - $1.50 |
Mylan, Teva, Sandoz, Others |
The shift towards generics is driven by patent expirations from 2017 onward, reducing prices and increasing accessibility.
Patent Status
- Original patent expiry occurred in 2006.
- No recent patents restrict generic competition.
- Patent litigations have had minimal impact in recent quarters.
Regulatory and Reimbursement Trends
- FDA approved Bupropion XL in 2006, SR in 1996.
- Insurance coverage largely favors generics; copay differences incentivize generic use.
- Recent CMS policies promote cost savings, fueling generic prescriptions.
Price Projections
Short-term Outlook (1-2 years)
- Average price per tablet for generics remains stable around $0.70–$1.00.
- Brand version (Wellbutrin) maintains a premium, averaging $2.50–$4.00 per tablet.
- Price erosion in generics expected to stabilize with supply chain dynamics and manufacturing costs.
Long-term Projections (3-5 years)
- Prices for generics likely will decline slightly, reaching $0.50–$0.80 per tablet due to increased competition.
- Brand prices expected to remain stable or decline marginally, considering market pressures.
- Impact of biosimilars or new formulations is minimal, given the drug’s patent landscape.
Factors Impacting Price Movements
- Entry of new generics or biosimilars.
- Regulatory changes affecting manufacturing or approval processes.
- Supply chain disruptions, especially during market shifts or pandemics.
- Reimbursement policy shifts favoring cost-effective drugs.
Market Drivers and Risks
Drivers
- Increasing prevalence of depression and smoking-related health issues.
- Expanded indications of bupropion, including weight management and ADHD.
- Cost benefits favoring generic substitution.
Risks
- Potential emergence of new depression treatments with superior efficacy.
- Regulatory shifts restricting off-label uses.
- Price warfare among manufacturers, pressuring margins.
Key Takeaways
- The market for NDC 00054-0284 is largely driven by generics, accounting for the majority of sales.
- Prices for generics are expected to decline gradually, stabilizing in a range of $0.50–$1.00 per tablet over the coming five years.
- Brand prices, though higher, are relatively stable due to limited competition and brand loyalty.
- Market growth is supported by rising depression diagnoses and smoking cessation efforts, but price pressures persist.
- Regulatory and reimbursement policies favor cost-efficient generic options, influencing future pricing strategies.
FAQs
Q1: Are there any upcoming patent expirations for bupropion formulations?
A1: No recent patents are active beyond 2017; all formulations are open for generic competition.
Q2: Will new formulations or drug delivery methods impact prices?
A2: Currently, no; existing forms dominate the market and are not expected to be challenged shortly.
Q3: How do insurance policies influence the market?
A3: Insurance companies favor generics, which supports stable or declining prices due to increased volumes and reduced costs.
Q4: What is the primary driver of market growth?
A4: Increasing diagnoses of depression and smoking cessation programs drive prescription volumes.
Q5: What factors could cause price increases?
A5: Supply shortages, regulatory hurdles, or patent litigation could temporarily elevate prices, but these are unlikely in the current landscape.
References
- IQVIA. (2022). Pharmaceutical Prescription Data.
- U.S. Food and Drug Administration (FDA). (2006). Approval of Bupropion Extended-Release Tablets.
- U.S. Patent and Trademark Office. (2017). Patent status of Bupropion formulations.
- Centers for Medicare & Medicaid Services (CMS). (2022). Reimbursement Policies for Mental Health Medications.
