Last updated: March 19, 2026
What is the drug associated with NDC 00169-4415?
NDC 00169-4415 corresponds to Bupropion Hydrochloride Extended-Release (SR), marketed under the brand name Wellbutrin SR. It is indicated primarily for depression and smoking cessation.
What is the current market landscape?
Market Size and Growth
- The global antidepressant market was valued at approximately USD 15 billion in 2022[1].
- The market for smoking cessation aids, including bupropion, is estimated at USD 2.2 billion in 2022[2].
- The combined market for bupropion formulations is projected to grow at a CAGR of around 4% from 2023 to 2028[3].
Key Competitors
| Drug Name |
Market Share |
Indications |
Price Range (per 30-day supply) |
| Wellbutrin SR |
Approx. 35% |
Depression, smoking cessation |
USD 220 - 330 |
| Zyban (bupropion) |
Approx. 20% |
Smoking cessation |
USD 210 - 310 |
| Other SSRIs and SNRIs |
Remaining |
Various depression treatments |
USD 150 - 300 |
Pricing Dynamics
- The average wholesale price (AWP) for Wellbutrin SR varies based on dosage and formulation.
- Generic versions have reduced prices by approximately 50% compared to branded formulations.
- Insurers often negotiate discounts, reducing out-of-pocket costs for covered patients.
What are the regulatory and patent considerations?
Patent Status
- The original patent for Wellbutrin SR expired around 2012[4].
- Several secondary patents on formulations and delivery methods extended market exclusivity until roughly 2021[4].
- Current market is predominantly composed of generic versions.
Regulatory Environment
- FDA approved for depression and smoking cessation indications.
- Recent approval of extended-release formulations for additional indications remains pending or under study.
- No major regulatory barriers foreseen for generic competitors.
What are the price projection trends?
Short-term (Next 1-2 Years)
- Prices for generic bupropion SR are projected to remain stable.
- Slight decrease expected due to increased generic availability.
- Brand-name Wellbutrin SR prices may decline by 10-15% as market saturation increases.
Medium-term (3-5 Years)
- Introduction of biosimilars or new formulations could influence prices.
- Competition from alternative smoking cessation drugs (e.g., varenicline) might pressure prices downward.
- Price erosion of brand-name products is expected to accelerate.
Long-term (Beyond 5 Years)
- Price stability or further decline likely as patent protections are fully exhausted.
- Market shifts toward combination therapies or novel indications could alter pricing, but current trends favor downward pressure.
What factors influence future prices?
- Accelerated generic market entry reduces branded drug sales.
- Changes in insurance reimbursement policies.
- New therapeutic approvals or evidence disrupting existing treatment paradigms.
- Manufacturing costs and supply chain stability.
Summary
- The market for NDC 00169-4415 (bupropion SR) is mature with significant generic presence.
- Prices are expected to decline gradually, driven by increased generics and competition.
- The total market size remains stable with moderate growth prospects given broader mental health and smoking cessation needs.
- Strategic positioning benefits from monitoring regulatory changes, patent statuses, and new competing therapies.
Key Takeaways
- The dominant sales channel is generics, with brand prices declining due to competition.
- Future price reductions are likely, especially if new entrants or formulations enter the market.
- The segment is mature but continues to grow modestly.
- Cost containment measures and insurance policies will further influence pricing trajectories.
- Potential therapeutic innovations could shift market dynamics but are not imminent.
FAQs
1. Is the price of NDC 00169-4415 likely to increase in the future?
Not generally; prices are expected to decrease due to generic competition unless new formulations or indications emerge.
2. How does the price of Wellbutrin SR compare with generics?
Branded Wellbutrin SR typically retails at USD 220–330 per 30-day supply, while generics range from USD 150–250.
3. What impact will patent expirations have on pricing?
Patent expirations usually lead to price declines as generic manufacturers enter the market, further intensifying competition.
4. Are there planned regulatory changes that may affect pricing?
Currently, no significant regulatory changes are expected; however, new indications or formulations could influence prices.
5. How do insurance reimbursements affect the actual out-of-pocket costs?
Insurance negotiations and formulary placements result in variable patient costs, often lowering the effective price paid out-of-pocket.
References
[1] Market Research Future. (2022). Global antidepressant market report.
[2] Grand View Research. (2022). Smoking cessation aids market analysis.
[3] MarketsandMarkets. (2023). Pharmacological market forecasts 2023-2028.
[4] U.S. Patent and Trademark Office. (2021). Patent expiration timeline for Wellbutrin SR.
