Last updated: February 24, 2026
Summary:
NDC 10702-0001 is a pharmaceutical product marketed under the name Bupropion Hydrochloride Extended-Release (SR). This drug is primarily used for smoking cessation and depression. It faces competition from generic formulations and branded products like Wellbutrin and Zyban. Market dynamics, patent status, manufacturing capacity, and evolving regulatory policies influence its pricing and market share.
Product Overview
| Attribute |
Details |
| Active Ingredient |
Bupropion Hydrochloride |
| Strengths |
100 mg, 150 mg, 200 mg (extended-release) |
| Formulation |
Extended-release tablets (SR) |
| Indications |
Major depressive disorder, smoking cessation support |
| Approval Date |
1985 (FDA approval for depression), 2000 (smoking cessation) |
Market Landscape
Clinical Need & Utilization
Bupropion is a first-line treatment for depression and aids smoking cessation.
Market data (2022) indicates:
- Total U.S. prescriptions: approximately 19 million units annually.
- Major users: Insurance companies, outpatient clinics, and mental health providers.
- Growth drivers: Increasing awareness of mental health, smoking cessation programs.
Competition
| Product Name |
Type |
Market Share (2022) |
Price Range (per unit) |
Notes |
| Wellbutrin (brand) |
Brand, proprietary |
45% |
$8.00 - $12.00 |
Patented until 2008; last patent expired in 2017 |
| Generic Bupropion SR (Various) |
Generics, multiple brands |
45% |
$2.00 - $5.00 |
Dominating market segment |
| Zyban (brand) |
Brand for smoking aid |
5% |
$10.00 - $15.00 |
Prescribed specifically for smoking cessation |
| Other generics and biosimilars |
Various |
5% |
$2.00 - $4.50 |
Increasing market penetration |
Patent and Exclusivity Status
- The initial patent expired in 2008.
- No recent patent protections or exclusivities for NDC 10702-0001, enabling widespread generic competition.
- Recent patent litigations have vacated certain exclusivity rights.
Pricing Analysis
Historical Price Trends
| Year |
Average Wholesale Price (AWP) per unit |
Notes |
| 2018 |
$6.75 |
Before patent expiry |
| 2020 |
$4.20 |
Post-generic entry |
| 2022 |
$3.50 |
Market stabilizes at lower levels |
Current Price Projections (2023–2027)
| Year |
Estimated Price Range (per unit) |
Factors Influencing Price |
| 2023 |
$3.50 - $4.00 |
Stable competition, increased supply |
| 2024 |
$3.25 - $3.75 |
Price erosion with market maturation |
| 2025 |
$3.00 - $3.50 |
Continued generic penetration |
| 2026 |
$2.75 - $3.25 |
Market saturation |
| 2027 |
$2.50 - $3.00 |
Potential price stabilization |
Key Variables Impacting Price
- Market share decline of branded products (Wellbutrin, Zyban) will push prices downward.
- Manufacturing capacity increases may lead to further price cuts.
- Healthcare policy shifts favoring generics could accelerate price erosion.
- Supply chain disruptions (e.g., raw material issues) could temporarily stabilize or raise prices.
Regulatory and Policy Impact
- The absence of active patent protections means no regulatory barriers inhibit generic manufacturers.
- Generic approval pathways via the ANDA process simplify market entry.
- Price controls or negotiations, especially under Medicare Part D, may influence retail and wholesale prices.
Strategic Recommendations
- Investors should monitor generic market shares; rapid growth suggests margin compression.
- Manufacturers can explore new indications or formulations to sustain margins.
- Suppliers should anticipate pricing stabilization and focus on cost efficiencies.
Key Takeaways
- NDC 10702-0001 faces significant competition from generics, with prices decreasing steadily.
- Market share is predominantly held by generics, with branded products declining sharply.
- Price projections indicate a continued downward trend, stabilizing around $2.50–$3.00 per unit by 2027.
- Patent expiration in 2008 and subsequent generic approvals shape the current landscape.
- Policy environments favor generic growth, further pressuring prices.
FAQs
Q1: How does patent expiration impact the price of NDC 10702-0001?
Patent expiration allows multiple generic manufacturers to enter the market, increasing competition and reducing prices.
Q2: What are the main competitors of NDC 10702-0001?
Generic formulations of bupropion SR dominate, along with branded Wellbutrin and Zyban products.
Q3: Could new patents or exclusivities re-emerge for this drug?
Unlikely. No recent patent filings or exclusivity extensions are associated with this NDC.
Q4: How might healthcare policy changes affect this market?
Policies favoring generics and price negotiations could further reduce prices and market share for branded products.
Q5: What is the outlook for manufacturing capacity?
Manufacturers have increased capacity, which supports stable supply but pressures prices downward.
References:
- U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Data.
- IQVIA. (2022). Prescription Drug Market Analysis.
- Generic Pharmaceutical Association. (2023). Market Trends Report.
- Martin, A. (2021). Patent expiry impacts on drug pricing. Journal of Pharma Economics.
- Medicaid and Medicare Price Data, 2022.
[1] U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Patent Data.
