Last updated: July 29, 2025
Introduction
NDC 00113-2007 corresponds to Bupropion Hydrochloride Extended-Release (SR), 100 mg. As a widely prescribed antidepressant and smoking cessation aid, Bupropion faces competitive pressure from generics, patent expirations, and evolving regulatory landscapes. This analysis explores the current market status, competitive environment, regulatory considerations, and forecasts future pricing trends for this specific formulation.
Market Overview
Product Profile and Therapeutic Use
Bupropion SR (sustained release) has established itself as a versatile antidepressant with off-label uses including smoking cessation, attention deficit hyperactivity disorder (ADHD), and obesity management. The 100 mg dosage serves as the foundational strength in titration and maintenance regimens.
Historical Sales and Adoption
Annual sales for Bupropion products, especially Wellbutrin, have seen fluctuations influenced by patent cliffs, generic entry, and shifts toward newer antidepressants such as SSRIs and SNRIs. According to IQVIA data (2022), Bupropion's generic formulations account for approximately 70-80% of prescriptions in the antidepressant segment, underscoring its market penetration.
Patent and Regulatory Status
The original patent for Wellbutrin was expiring around 2017, leading to an influx of generics. As of now, multiple generic manufacturers produce Bupropion SR 100 mg, resulting in intense price competition. The FDA's Orange Book indicates no remaining patents on the 100 mg dose, confirming the market is dominated by generic formulations.
Competitive Landscape
Generic Competition
Major generic players include Mylan (now part of Viatris), Apotex, Sandoz, and Teva, all offering Bupropion SR 100 mg. Market entry of these generics has significantly driven prices downward, in line with typical post-patent expiry trends.
Brand vs. Generic
The brand-name Wellbutrin SR (AbbVie) maintains a premium pricing position, but prescriptions have largely shifted to generics, particularly in institutional settings and insurance formulary preferences. As of 2022, approximately 85% of Bupropion prescriptions originate from generics.
Market Distribution Channels
The medication is predominantly dispensed through retail pharmacies, outpatient clinics, and hospital formularies. Favorable pricing and formulary inclusion favor generics, further suppressing brand-name sales.
Pricing Trends and Projections
Current Price Dynamics
Based on current data from the Red Book and GoodRx (Q1 2023), the average retail price for a 30-count bottle of 100 mg Bupropion SR tablets ranges from $8 to $15, translating to approximately $0.27 to $0.50 per tablet. Insurance negotiations and rebates significantly influence actual patient costs, often reducing the effective price.
Historical Price Trends
Post-patent expiry, prices for Bupropion SR 100 mg have declined swiftly within the first 1-2 years. Over the past five years, average prices have stabilized at lower levels, reflecting the mature generic market.
Future Price Projections (Next 3-5 Years)
Given the dominance of generics, prices for Bupropion SR 100 mg are expected to remain relatively flat or decline marginally due to increased competition and potential market saturation:
-
Scenario 1: Stable Competition
- Prices remain within the current range, with minor annual declines (~1-2%) driven by manufacturing efficiencies and increased competition.
-
Scenario 2: Increased Market Penetration
- Further prescribing shifts towards even lower-cost generics or biosimilars (if applicable), potentially reducing prices by an additional 3-5% annually.
-
Scenario 3: Regulatory or Market Disruptions
- Introduction of new formulations or delivery systems (e.g., patches or depot injections) could influence demand and pricing, but such innovations are unlikely in the immediate future.
Overall Best Estimate:
Average wholesale prices for Bupropion SR 100 mg could hover around $0.25 to $0.40 per tablet over the next five years, assuming current market dynamics persist.
Regulatory and Market Forces Impacting Future Prices
- FDA Approvals: Ongoing approvals of generic substitutes will continue exerting downward pressure.
- Rebate and Insurance Policies: Payer preferences favor generics, keeping prices suppressed.
- Manufacturing Costs: Improved manufacturing efficiencies may facilitate further price reductions.
- Market Potential in New Indications: Expansion into off-label uses may temporarily boost demand but will not significantly alter price trends unless accompanied by patent protection.
Implications for Industry Stakeholders
- Pharmaceutical Companies: Investing in innovative formulations or combination therapies could allow differentiation amid fierce generic competition.
- Distributors and Pharmacies: Volume-based purchasing strategies can optimize margins amidst low per-unit prices.
- Insurers: Favoring low-cost generics aligns with cost-containment goals, further cementing generic dominance.
Key Takeaways
- Market Saturation: The Bupropion SR 100 mg market is mature, highly competitive, and predominantly served by generics, resulting in stabilized and declining prices.
- Price Forecast: Over a five-year horizon, expect minimal fluctuations with prices remaining within current low-range wholesale or retail levels (~$0.25 to $0.40 per tablet).
- Competitive Environment: Price erosion driven by generic proliferation and payer strategies will persist, limiting the prospects for significant price increases.
- Innovation Opportunities: Developing new delivery systems or combination products presents potential for premium pricing but is unlikely solely for this formulation without patent protection.
- Strategic Focus: Stakeholders should prioritize cost-effective sourcing, formulary positioning, and exploring novel therapeutic niches to optimize returns.
FAQs
1. How does patent expiration influence Bupropion's market prices?
Patent expiration introduces generic competition, significantly reducing prices due to increased supply and price sensitivity. With no remaining patents on NDC 00113-2007, generics dominate, keeping prices low.
2. Are there upcoming regulatory changes likely to impact prices?
Currently, no significant regulatory shifts are anticipated specific to this formulation. However, future approvals of biosimilars or alternative delivery systems could alter the competitive landscape.
3. What role do insurance companies play in controlling Bupropion prices?
Insurance payers favor generic drugs to reduce costs, often negotiating rebates and formulary placements that favor the lowest-cost options, further suppressing retail prices.
4. Can brand-name versions command premium prices in this market?
Generally, no. The price gap between brand-name and generics has narrowed, with generics accounting for the majority of prescriptions due to cost advantages.
5. What strategies should manufacturers consider to maintain profitability?
Focusing on manufacturing efficiencies, expanding indications, and developing value-added formulations can help sustain margins despite falling prices.
Sources
[1] IQVIA. Market Analytics and Prescription Data, 2022.
[2] FDA Orange Book. Patent and Exclusivity Information, 2023.
[3] GoodRx. Prescription Drug Pricing Trends, Q1 2023.
[4] Red Book. Drug Price and Wholesale Data, 2023.
[5] Industry Reports. Generic Pharmaceutical Market Dynamics, 2022.
This comprehensive market and price analysis provides a data-driven foundation for strategic decision-making regarding NDC 00113-2007, supporting stakeholders in navigating the evolving landscape of Bupropion SR.
