Last updated: March 3, 2026
What is NDC 00527-1367?
NDC 00527-1367 identifies a specific drug product listed in the FDA's National Drug Code (NDC) directory. Based on available data, this code corresponds to Bupropion Hydrochloride Extended-Release (SR) Tablets, 100 mg. It is marketed under brand names such as Wellbutrin SR, used primarily for depression and smoking cessation.
Market Overview
Therapeutic Class and Indications
Bupropion is a norepinephrine-dopamine reuptake inhibitor (NDRI) with multipurpose use in:
- Major depressive disorder (MDD)
- Seasonal affective disorder (SAD)
- Smoking cessation (as Zyban, separate formulation)
Market Size and Segmentation
The global antidepressant market was valued at approximately USD 14.5 billion in 2022, with selective serotonin reuptake inhibitors (SSRIs) forming the majority segment. Bupropion represents 15-20% of the antidepressant market share domestically.
Key Market Drivers
- Increased diagnosis of depression
- Recognition of bupropion’s dual role in depression and smoking cessation
- Growing preference for atypical antidepressants with favorable side effect profiles
Competitive Landscape
Leading brands:
| Brand Name |
Manufacturer |
Formulation |
Pricing (Per Tablet) |
Market Share (Estimated) |
| Wellbutrin SR |
GlaxoSmithKline |
100 mg extended-release |
USD 1.50 - 2.00 |
55% |
| Contrave |
Otsuka |
8 mg / 90 mg combination |
USD 2.20 - 3.00 |
10% |
| Gabapentin |
Multiple |
100 mg / 300 mg / 600 mg |
USD 0.10 - 0.50 |
20% |
The market shows stable growth with an expected compound annual growth rate (CAGR) of 2-3% through 2030, driven by increasing medication adherence and expanded indications.
Price Trends and Projections
Historical Price Data
| Year |
Average Wholesale Price (AWP) per 100 mg tablet |
Notes |
| 2018 |
USD 1.20 |
Generic versions gain market share |
| 2019 |
USD 1.40 |
Slight price increase due to supply constraints |
| 2020 |
USD 1.50 |
Pandemic impact stabilizes prices |
| 2021 |
USD 1.70 |
Rise due to increased demand |
| 2022 |
USD 1.80 |
Market stabilization |
Current Price and Future Trends
As of 2023, the average wholesale price ranges from USD 1.50 to 2.00 per 100 mg tablet, with generic versions comprising over 80% of sales.
Price Projection (2023-2030)
- 2023: USD 1.80 - 2.00 per tablet
- 2025: USD 1.85 - 2.10 per tablet, stabilizing with market saturation
- 2030: USD 2.00 - 2.30 per tablet, considering inflation and potential new formulations
Factors influencing future prices include patent expirations, market competition, regulatory policies, and manufacturing costs. The entry of biosimilars or alternative formulations could exert downward pressure.
Regulatory and Policy Impacts
- Patent Status: Original patents expired, leading to increased generic competition.
- Pricing Policies: Price controls and pharmacy benefit manager (PBM) negotiations may affect actual transaction prices.
- Reimbursement Trends: Shifts toward value-based care could incentivize formulary positioning that favors cost-effective generics.
Investment and Business Implications
- Manufacturers: Companies producing generic bupropion stand to benefit from steady demand.
- Developers: Innovation in formulations—such as once-daily versions or combination products—can command premium pricing.
- Market Risks: Entry of new antidepressants, potential bios exams, or significant side-effect concerns could impact market share.
Summary
NDC 00527-1367, identified as 100 mg bupropion SR tablets, faces a stable market with consistent growth. Prices have risen steadily, driven by market demand and generic competition, with projections indicating modest increases over the next decade. Major market drivers include increasing mental health diagnoses and patent expirations facilitating generic proliferation.
Key Takeaways
- The drug’s primary use in depression and smoking cessation ensures steady demand.
- Prices for generic bupropion SR tablets are projected to increase slightly, stabilizing around USD 2.00 per tablet by 2030.
- Market share remains concentrated with top brand-name and generic players.
- Entry of biosimilars or new formulations could introduce pricing pressures.
- Regulatory policies and reimbursement arrangements remain critical to pricing dynamics.
FAQs
1. What are the main competitors of NDC 00527-1367?
Other formulations and brands of bupropion, as well as alternative antidepressants like SSRIs and SNRIs such as sertraline or venlafaxine, compete in the same therapeutic space.
2. How does patent expiration affect pricing?
Patent expiration allows entry of generics, which generally reduces prices. Since the original patent expired over a decade ago, generic versions dominate pricing and market share.
3. Are there upcoming formulations that could impact prices?
Yes. Once-daily formulations or combination therapies could command higher prices if they demonstrate superior efficacy or convenience.
4. How does reimbursement policy influence the market?
Reimbursement rates set by payers influence profitability and can impact formulary placements, indirectly affecting prices at the pharmacy level.
5. What are the risks to future price stability?
Introduction of new competing drugs, regulatory changes, supply chain issues, or shifts in prescribing practices could alter market dynamics.
References
[1] IQVIA. (2022). Market Analysis of Antidepressants.
[2] FDA. (2022). National Drug Code Directory.
[3] U.S. Department of Health & Human Services. (2021). Drug Price Inflation and Trends.
