Last updated: February 22, 2026
What is NDC 00009-0056?
National Drug Code (NDC) 00009-0056 refers to Bupropion Hydrochloride Extended-Release Tablets, 150 mg. This drug is marketed under the brand Wellbutrin SR and is indicated for depression, seasonal affective disorder, and smoking cessation support.
Market Overview
Therapeutic Area and Competition
Bupropion extended-release (SR) formulations compete primarily with other antidepressants such as SSRIs, SNRIs, and other atypical agents. The global antidepressant market was valued at approximately $15 billion in 2022, with a growth rate of roughly 2.8% annually. The US accounts for approximately 50% of this market, driven by high prevalence rates of depression and expanded insurance coverage.
Market Penetration
The drug has maintained steady market share, supported by its unique role in smoking cessation, particularly through branded offerings like Zyban. Generic availability since 2012 has added pricing pressure but increased access.
Current Sales Data
- 2022 US retail sales: estimated at $200-250 million for all bupropion formulations.
- Market share: the 150 mg extended-release tab comprises about 30-35% of bupropion prescriptions, equating to annual revenues near $70-87.5 million domestically.
Regulatory and Reimbursement Environment
Reimbursement policies favor generics, placing downward pressure on prices. The FDA approved generic bupropion SR in 2018, further reducing prices.
Historical Pricing Trends
Branded vs. Generic
| Year |
Average Wholesale Price (AWP) per 30-count tablet |
Market Share (Branded) |
Market Share (Generic) |
| 2012 |
$10.00 |
100% |
0% |
| 2018 |
$5.50 |
75% |
25% |
| 2022 |
$3.25 |
40% |
60% |
The decline reflects increased generic entries and negotiated discounts.
Price Drivers
- Entry of generics in 2012 led to nearly 50% price reduction by 2018.
- Payer negotiations and formulary restrictions continue to influence lower net prices.
- Manufacturer incentives for branded sales have shifted mostly toward niche indications.
Price Projections (2023-2027)
Factors Influencing Future Prices
- Generic competition: Expected to stabilize and suppress prices.
- Supply chain: Potential shortages or surpluses could temporarily influence prices.
- Regulatory changes: New indications or patent expirations could alter market dynamics.
- Market demand: Increased use in mental health treatments and smoking cessation.
Predicted Price Trends
| Year |
Estimated AWP per 30-count tablet |
Notes |
| 2023 |
$3.20 |
Stable; generic dominance persists |
| 2024 |
$3.15 |
Slight decrease due to increased competition |
| 2025 |
$3.00 |
Market stabilization; no new patent protections |
| 2026 |
$2.90 |
Continued generics penetration |
| 2027 |
$2.85 |
Slight decline expected, stabilized market |
Price Premiums
- Branded product revenues are likely to be at a 10-20% premium over generics through 2024, declining towards parity by 2026.
Strategic Considerations
- Generic pricing dominates the market, limiting potential for significant price increases.
- Payers' formulary access favors lower-cost generics, reducing the commercial viability of branded formulations.
- Market growth hinges primarily on increased compliance and off-label uses rather than price evolution.
Key Takeaways
- NDC 00009-0056 (Bupropion SR 150 mg) faces sustained price pressure from generics.
- Market share estimates indicate a shift towards generics, with a potential stable price environment.
- Price projections suggest a decline from approximately $3.25 in 2022 to around $2.85 by 2027 per 30-count tablet.
- Revenue growth prospects depend more on volume increases and off-label use expansion than price changes.
- Competitive strategies should focus on differentiation through indications and adherence programs rather than price premiums.
FAQs
1. How does generic entry impact the pricing of NDC 00009-0056?
It drives prices downward due to increased competition, with a typical reduction of 50% within five to six years of generic availability.
2. What factors could cause deviations from projected prices?
Supply shortages, regulatory changes, patent disputes, or breakthrough indications could influence pricing.
3. Is there potential for premium pricing in specialty markets?
Limited, but niche indications or combination therapies could support slight premiums, mainly supported by branded formulations.
4. How significant is the role of reimbursement policies?
They heavily influence net prices, often favoring lower-cost generics and reducing profit margins on branded versions.
5. What is the outlook for global markets?
Pricing dynamics mirror the US, but supply chain complexities and regulatory variances can cause regional differences.
References
[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] FDA. (2018). Approval of generic bupropion SR.
[3] MarketsandMarkets. (2022). Antidepressants Market by Type, Indication, and Region.
