Last updated: February 21, 2026
What is NDC 00781-3476?
NDC 00781-3476 identifies a specific drug product, which is a brand-name medication. Based on current databases, this NDC corresponds to Bupropion Hydrochloride Extended-Release (SR) 100 mg by GlaxoSmithKline. This medication is used primarily for depression and smoking cessation.
Market Landscape for Bupropion Extended-Release (100 mg)
Industry Size and Growth Drivers
The market for Bupropion extended-release formulations covers several therapeutic areas, including depression, ADHD, and smoking cessation. The global antidepressant market was valued at approximately USD 15 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 2.5% through 2027 [[1]].
Key drivers include:
- Rising prevalence of depression and anxiety disorders.
- Increased adoption of pharmacotherapy for smoking cessation.
- Demand for long-acting formulations for patient adherence.
Competitive Landscape
Major competitors include:
- Branded products: Wellbutrin SR by GlaxoSmithKline.
- Generic equivalents: Several companies including Teva, Mylan, and Sun Pharmaceutical.
Pricing varies significantly by manufacturer, distribution channel, and pharmacy.
Pricing Data for NDC 00781-3476
Current Price Range (as of Q1 2023)
| Source |
Price per unit (100 mg tablet) |
Notes |
| Retail pharmacy (cash) |
USD 0.25 - USD 0.80 |
Varies by location and discounts |
| Wholesale acquisition cost (WAC) |
USD 0.18 - USD 0.60 |
Price for pharmacy purchase before rebates |
| Average wholesale price (AWP) |
USD 0.30 - USD 1.00 |
Often used as benchmark for pricing |
Reimbursement and Medicare
Average reimbursement for branded Bupropion SR is higher than generics; Medicare Part D covers most costs, leading to average patient copayments of USD 5-10 per month for typical prescriptions.
Patient Cost Considerations
- Brand-name Wellbutrin SR: USD 250 - USD 350 per month.
- Generic Bupropion SR: USD 10 - USD 30 per month with insurance and coupons.
Price Projections
Short-term Outlook (Next 12 Months)
- Price stabilization: Due to market saturation, generic prices are expected to remain within the current range.
- Supply chain influence: Raw material costs (e.g., active pharmaceutical ingredients or APIs) may cause slight variability in wholesale prices, but overall impact is limited.
Medium-term Outlook (1-3 Years)
- Generic entry impact: Price erosion anticipated for Bupropion SR, driven by increased generic competition.
- Potential for biosimilar or alternative formulations: No biosimilars exist; however, new formulations (e.g., sustained-release patches) could alter market dynamics.
Long-term Outlook (3+ Years)
- Market maturity: Expect continued price decline with broader adoption of generics.
- New indications: If expanded into new therapeutic areas, pricing could shift accordingly, but no official pipeline data suggests imminent change.
Regulatory and Policy Environment
- The FDA has approved multiple generics, including Bupropion Hydrochloride Extended-Release Tablets from several manufacturers.
- Policies encouraging generic substitution and pricing transparency are likely to drive further price competition.
- Patent expirations typically occur 8-12 years after approval; for Wellbutrin SR, patent challenges began around 2014, leading to increased generic competition by 2016.
Market Entry and Revenue Potential
- New entrants could capture market share by underpricing established generics.
- Private label or competing formulation launches would pressure prices.
- Estimated revenue for established products is projected to decline by approximately 10-15% annually over the next three years, aligned with generic market saturation.
Summary of Market Dynamics
| Factor |
Impact |
| Market size |
USD 15 billion (global antidepressant market) |
| Current price range |
USD 0.18 - USD 1.00 per tablet |
| Competition |
Multiple generic manufacturers |
| Price trend |
Decline over medium-to-long term |
| Regulatory environment |
Favoring generic proliferation |
Key Takeaways
- NDC 00781-3476 corresponds to a generic Bupropion SR 100 mg tablet.
- It operates in a competitive, price-sensitive market with a significant portion of revenue from generics.
- Prices are expected to remain stable in the short term but decline gradually as generic competition increases.
- Market growth is primarily driven by rising mental health treatment rates and smoking cessation initiatives.
- Long-term pricing will depend on regulatory changes, formulation innovations, and patent litigation outcomes.
FAQs
1. How does the pricing of NDC 00781-3476 compare to other formulations of Bupropion?
Extended-release formulations like 150 mg or 300 mg have higher per-unit costs, typically USD 0.40 - USD 1.50 per tablet. Lower-dose formulations are generally priced proportionally and may differ based on manufacturer strategies.
2. What factors influence the price of generic Bupropion?
Manufacturing costs, competition, supply chain conditions, and negotiated rebates influence prices. Market entry of additional generics tends to lower prices further.
3. Are there upcoming patent expirations or legal challenges affecting this drug?
Bupropion SR's original patents expired around 2016. Current patents do not cover basic formulations, enabling broad generic competition.
4. What is the impact of payer policies on drug pricing?
Payer policies favor generics, leading to lower out-of-pocket costs for patients and incentivizing pharmacies to dispense less expensive options.
5. Is there potential for new formulations or delivery methods to affect the market?
Yes. Long-acting transdermal patches or novel sustained-release systems could introduce new competitors, affecting prices.
References
[1] MarketsandMarkets. (2022). Antidepressant Drugs Market by Product Type, Distribution Channel, and Region. Available at: https://www.marketsandmarkets.com
