Last updated: March 13, 2026
What is NDC 46122-0771?
NDC 46122-0771 references a specific drug product listed in the United States National Drug Code Directory. According to available data, this code corresponds to Bupropion Hydrochloride Extended-Release (SR) and Extended-Release (XL) formulations used for depression and smoking cessation.
Market Size and Demand
Current Market Landscape
- Indications: Depression, smoking cessation support, sometimes off-label for ADHD.
- Market Volume: Estimated at approximately 10 million prescriptions annually in the U.S. (IQVIA, 2022).
- Therapeutic Segment: Dominated by generic formulations, capturing over 90% of prescriptions within the depression treatment market.
Competitive Environment
- Major Players: Multiple generic manufacturers dominate. Name-brand competitors include GlaxoSmithKline and novel entrants with biosimilar or extended-release formulations.
- Patent Status: The original patents on Bupropion formulations expired between 2014 and 2018, leading to widespread generics.
Market Trends
- Growth Drivers: Increased awareness of mental health, expanding indications, and physician preference for well-established, generic options.
- Challenges: Competition from newer antidepressants (e.g., vortioxetine, vilazodone), patent expirations leading to price erosion of key formulations.
Price Trends and Projections
Historical Pricing Data (Average Wholesale Price - AWP)
| Year |
Average AWP per 30-day supply |
Comment |
| 2018 |
$60 |
Initial post-patent expiry |
| 2020 |
$45 |
Price erosion continues |
| 2022 |
$30 |
Market stabilization |
Note: Prices for generic formulations have significantly declined with increased manufacturing competition.
Current Pricing (2023)
- Average AWP: Approximately $25-$35 for a 30-day supply.
- Consultation with pharmacy data: Retail prices range from $15 (dispensed as generic) to $50 (cost for brand or specialized formulations).
Future Price Projection (Next 3 Years)
| Year |
Predicted AWP Range |
Assumptions |
| 2024 |
$20 - $30 |
Increased generic competition persists, no new formulations or patents. |
| 2025 |
$18 - $28 |
Continued price erosion; potential entry of biosimilars or new delivery systems. |
| 2026 |
$15 - $25 |
Market saturation; price stabilization at lower levels. |
Assumptions: Absent regulatory changes, patent reinstatements, or new delivery methods that could influence pricing, steady decline is expected.
Revenue Forecasting
- Market volume: 10 million prescriptions annually.
- Average price per prescription (2023): $30.
- Projected revenue (2023): $300 million.
Assuming a 10% annual decline in average price, revenue could decrease to approximately $270 million in 2024 and $243 million in 2025 if volume remains constant.
Regulatory and Policy Impact
- Generic Drug Policies: Streamlined approval pathways for generics reduce market prices.
- Insurance Coverage: Favorable coverage for generics keeps retail prices competitive but limits premium pricing.
- Potential legislative changes could impact patent protections or introduce drug pricing reforms.
Key Takeaways
- The drug corresponding to NDC 46122-0771 is a generic Bupropion extended-release formulation.
- Market demand is stable but faces intense competition from generics.
- Prices have declined from around $60 to approximately $25-$35 in recent years.
- Future price declines are expected, with prices potentially stabilizing around $15-$25 over the next three years.
- Annual revenues are forecasted around $250–$300 million, with downward pressure amid increased competition.
FAQs
Q1: Will this drug become non-competitive due to new therapies?
A1: New antidepressant formulations may impact market share, but generics are likely to maintain significant volume due to lower price points and established efficacy.
Q2: Are there patent protections still in effect?
A2: No, primary patents expired between 2014 and 2018, allowing generic manufacturing.
Q3: How could regulatory changes affect pricing?
A3: Legislation promoting biosimilars or drug price reforms could further decrease prices or shift market dynamics.
Q4: Is there scope for premium pricing?
A4: Limited; the market is saturated with generics, constraining premium pricing unless reformulations or delivery innovations emerge.
Q5: What is the key driver for future market growth?
A5: Increased mental health awareness and broader indications could sustain demand despite falling prices.
References
- IQVIA. (2022). National Prescription Audit.
- FDA. (2018). Patent Expiry and Generic Entry Data.
- MedTrack. (2023). Pricing Trends for Bupropion Formulations.
- SSR Health. (2022). Prescription Volume and Revenue Data for Depression Treatments.
- CMS. (2023). Drug Pricing and Coverage Policies.
