Last updated: February 13, 2026
Product Overview
NDC 76282-0679 is identified as Rimonabant, a drug that was developed for obesity and smoking cessation. It was marketed under the brand name Acomplia by Sanofi-Aventis but was withdrawn from the market in 2008 due to safety concerns, specifically psychiatric adverse effects.
Market Status
- Market Withdrawal: Abandoned globally since 2008 after FDA and European Medicines Agency (EMA) safety warnings.
- Current Supply: No authorized new sales; remaining stock limited and primarily in secondary markets.
- Potential Resurgence: No recent indications of reformulation approvals or re-registrations by regulatory authorities.
Competitive Landscape
- Obesity Treatment: Dominated by drugs such as orlistat, liraglutide, phentermine-topiramate, and newer agents like semaglutide.
- Smoking Cessation: Main alternatives include varenicline (Chantix) and nicotine replacement therapy.
- Market Entry Barrier: High regulatory risk due to past safety issues; no current FDA or EMA approval.
Price History and Projections
- Historical Pricing: At peak, prescription price ranged from $200 to $300 per month (per pill pricing data before withdrawal).
- Market Value (Pre-Withdrawal): Estimated at over $150 million annually across Europe and North America.
- Post-Withdrawal Market: No current legal retail sales; secondary markets price residual stock at approximately $50–$100 per pill, due to obsolescence and safety profile concerns.
Future Price Projections
Considering regulatory and safety issues, the legal pathway for reentry remains unclear. Any resurgence would depend on:
- Reformulation and Safety Re-evaluation: Substantial clinical data to address safety concerns.
- Regulatory Approval: Likely requires a new NDA (New Drug Application) with comprehensive safety data.
- Market Demand: Limited owing to existing effective alternatives with better safety profiles.
Projected prices, if reapproved, could match original levels ($200–$300 per month). However, market penetration would face resistance, especially given safety concerns and available alternatives.
Regulatory and Legal Risks
Reintroduction faces significant hurdles:
- FDA/EMA Warnings: SHARP safety warnings persist.
- Legal Liabilities: Past safety issues have resulted in litigation and recalls.
- Post-Market Surveillance: Stringent requirements likely to push up costs and influence pricing.
Key Conclusions
NDC 76282-0679, Rimonabant, remains off-market with no current formal plans for reintroduction. The potential for price recoveries depends heavily on reforms, regulatory acceptance, and market demands. High safety concerns limit the commercial upside.
Key Takeaways
- Rimonabant’s market was globally withdrawn in 2008 due to safety risks.
- Residual stock may trade in secondary markets at discounted prices.
- Reintroduction requires significant reformulation and safety validation.
- Original pricing was $200–$300/month; future pricing, if reapproved, could match this but faces market resistance.
- Market entry is unlikely in the near term without substantial changes.
FAQs
1. Why was Rimonabant withdrawn globally?
It was withdrawn due to safety issues linked to psychiatric adverse effects, including depression and suicide risks.
2. Is there any current legal market for this drug?
No. It is not approved for sale by any major regulator with existing approvals paused or revoked.
3. Could reformulation lead to reapproval?
Potentially, but it would require extensive clinical data demonstrating improved safety, as well as regulatory approval processes.
4. What are the main competitors to Rimonabant today?
In obesity, orlistat, liraglutide, and semaglutide are primary. For smoking cessation, varenicline is dominant.
5. Is there any demand for Rimonabant in the market?
Market demand is minimal due to safety concerns and competition from newer drugs with better safety profiles.
References
- [Sanofi-Aventis Official Statements, 2008]
- [FDA and EMA Safety Warnings, 2008]
- [Pharmaceutical Pricing Databases, 2022]
- [Market Reports on Obesity and Smoking Cessation Drugs, 2023]
