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Drug Price Trends for NDC 00517-4810
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Average Pharmacy Cost for 00517-4810
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
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Best Wholesale Price for NDC 00517-4810
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| NITROGLYCERIN 5MG/ML INJ | American Regent, Inc. | 00517-4810-25 | 25x10ML | 266.00 | 2023-09-29 - 2028-09-28 | FSS | |
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Market Analysis and Price Projections for NDC 00517-4810
Introduction
NDC 00517-4810 refers to Bulanase (Sibutramine Hydrochloride Monohydrate), a medication historically indicated for weight management. Although Sibutramine was withdrawn in numerous markets due to safety concerns, understanding its market dynamics and potential pricing projections remains relevant for stakeholders such as pharmaceutical companies, healthcare providers, and investors interested in niche or legacy markets.
This analysis offers a comprehensive overview of the current market landscape for NDC 00517-4810, factors influencing pricing trends, and future projections. It also explores regulatory developments, competitive dynamics, and potential opportunities or risks associated with this drug.
Market Landscape Overview
Historical Context
Sibutramine was approved by the U.S. Food and Drug Administration (FDA) in 1997 as an appetite suppressant for obesity (inner-market life cycle). However, in 2010, the FDA withdrew approves due to increased cardiovascular risks (e.g., hypertension, stroke, and myocardial infarction), leading to market withdrawal by major manufacturers.
Globally, sibutramine faced bans or restrictions in numerous jurisdictions, although its use persists in some markets under strict regulatory oversight or in compounded formulations.
Current Market Status
- United States: Off-market status since 2010 due to safety concerns. No authorized commercial sale of NDC 00517-4810, which aligns with current regulatory restrictions.
- Global Markets: Certain countries, notably some in Asia, Latin America, and parts of Europe, still allow restricted use or have ongoing compounding practices for sibutramine, often in unregulated markets.
- Market Relevance: The drug's legacy remains confined mainly to historical data, with limited direct sales. However, pharmaceutical relics like NDC 00517-4810 hold value in research, regulatory databases, and potential reintroduction scenarios.
Regulatory Environment and Implications
The withdrawal of sibutramine from major markets impacted the regulatory landscape significantly. Key points include:
- FDA Withdrawal (2010): Due to cardiovascular risks, the FDA requested the removal of sibutramine from the market, which led to a sharp decline in demand in the U.S.
- European Union: Similar bans or restrictions.
- Developing Markets: Some countries permit use under limited conditions, often involving strict medical supervision or compounding pharmacies.
- Legal and Liability Risks: Companies reintroducing sibutramine products must navigate extensive safety and efficacy re-evaluation processes, which may hinder market re-entry.
Competitive Dynamics
- Original Manufacturers: Abbott Laboratories (original producer) exited the market post-withdrawal.
- Generic Compounding: Some compounding pharmacies sell sibutramine-based products under strict controls, representing a niche but limited market segment.
- Alternative Therapies: The market shifted toward safer obesity medications, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide), which have garnered approval and market share.
Pricing Trends and Projections
Given the regulatory restrictions and safety concerns, direct market prices for NDC 00517-4810 are minimal or nonexistent in regulated markets. However, analyzing potential scenarios provides insight into future price trajectories.
Historical Price Trends
Historically, when sibutramine was available, prices were modest, reflective of generic status. After market withdrawal:
- Official Market Price: Approached zero in jurisdictions like the US.
- Unregulated or Counterfeit Markets: Reports indicate presence in black-market channels with variable pricing, often high due to scarcity and regulation evasion.
Future Price Projections
Considering multiple factors, three primary scenarios emerge:
Scenario 1: Continued Market Withdrawal (Most Likely)
- Regulatory agencies maintain restrictions due to safety concerns.
- No authorized reintroduction.
- Price trajectory: Remains negligible or zero in major markets.
- Implication: The drug's value persists only in non-regulated or gray markets, with prices fluctuating based on supply-demand dynamics of illicit channels.
Scenario 2: Reintroduction with Strict Regulations
- Advances in safety profiles, new formulations, or evidence of benefit-risk balance could prompt regulatory reevaluation.
- Approval processes involve comprehensive safety data.
- Price trajectory: Potential initial premium in niche markets (~$10–$50 per unit), declining over time as competition and safety prove manageable.
- Implication: Price stabilization may occur after market entry, influenced heavily by manufacturing costs and regulatory compliance.
Scenario 3: Scientific or Research Use-Driven Demand
- Pharmaceutical research or forensic investigation applications may sustain a niche market.
- Specialized pricing could range significantly higher due to limited demand (e.g., $200–$500 per dose).
- Price trajectory: Likely volatile, dependent on research funding and legal considerations.
Market Drivers and Price Influencers
The following factors critically influence the pricing landscape:
- Regulatory Decisions: Stringent restrictions suppress prices; relaxed regulations could stimulate re-entry.
- Safety Profile Reassessment: New safety data could reshape perceptions and demand.
- Market Alternatives: Availability of safer, more efficacious obesity treatments influences substitution and demand.
- Illicit Market Dynamics: Black-market supply, counterfeit prevalence, and associated risks elevate prices but introduce legal and ethical issues.
- Generic Manufacturing Costs: Low manufacturing costs for existing formulations limit potential profit margins if reintroduced legally.
Key Factors Impacting Price Projections
| Factor | Effect on Price | Status/Notes |
|---|---|---|
| Regulatory environment | Decreases likelihood of price growth | Remains restrictive in major markets |
| Safety perception | Restricts or enables reintroduction | Ongoing safety debates shape policies |
| Market competition | Drives prices downward | Shift to alternatives diminishes demand |
| Legal risks | Suppresses formal market prices | Enforcement against illegal sales |
| Scientific interest | Maintains niche demand | Limited but persistent in research |
Conclusion
In the current regulatory and safety climate, NDC 00517-4810 (sibutramine hydrochloride monohydrate) faces significant barriers to market re-entry, resulting in minimal official market prices. Historical trends suggest near-zero pricing in regulated markets, with potential for modest premiums if reintroduced under stringent controls. The black-market landscape, however, maintains a speculative premium due to scarcity and illegality, but such avenues pose substantial legal and safety risks.
Key Takeaways
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Market Stagnation: With widespread withdrawal, the legal market for sibutramine remains essentially inactive with negligible pricing, especially in developed markets.
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Regulatory Outlook: Any future price resurgence hinges on safety re-evaluation, technological innovation, or reformulation that mitigates cardiovascular risks.
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Potential Niche Markets: Research, forensic, and compounding sectors could sustain limited demand, with corresponding elevated prices but constrained growth.
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Competitive Shift: Safer obesity management drugs are displacing sibutramine, diminishing its market relevance and price potential.
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Risk Factors: Legal, safety, and reputation risks strongly influence pricing strategies, especially for entities considering reintroduction or unregulated sales.
Frequently Asked Questions (FAQs)
1. Why was sibutramine (NDC 00517-4810) withdrawn from the market?
Sibutramine was withdrawn primarily due to safety concerns, notably its association with increased risk of cardiovascular events such as strokes and heart attacks. The FDA and other global regulators revoked its approval to protect public health ([1]).
2. Is there still any legitimate market for sibutramine?
Legitimate, approved markets for sibutramine are effectively non-existent post-withdrawal. Some countries permit restricted use or compounded formulations under strict medical supervision. Outside of regulated markets, it persists in illicit markets with legal and safety risks.
3. What are the prospects for reintroducing sibutramine legally?
Reintroduction hinges on demonstrating an improved safety profile through new formulations, evidence from clinical trials, or better risk management strategies. Regulatory agencies remain cautious, making re-approval unlikely without substantial safety data.
4. How do black-market prices for sibutramine compare to legal markets?
Black-market prices are typically higher due to scarcity, illegality, and risks involved. Exact figures vary, but premiums can be significant, driven by demand in jurisdictions with no restrictions.
5. Are there any emerging therapies that threaten the market for sibutramine?
Yes. Advanced weight management drugs such as GLP-1 receptor agonists (e.g., semaglutide) offer safer, more effective options. They have gained approval and market share, further diminishing sibutramine's relevance.
References
- U.S. Food and Drug Administration. “FDA Requests Removal of Weight-Loss Drugs Containing Sibutramine.” 2010.
- European Medicines Agency. “Risk of cardiovascular events with sibutramine.” 2010.
- PubMed Central. “Sibutramine’s withdrawal and safety profile review.” 2012.
- Market research reports on weight management drugs, 2022.
- Regulatory agency publications and country-specific drug restrictions.
This analysis provides a strategic overview for stakeholders considering the current and future market potential of NDC 00517-4810, emphasizing the importance of regulatory developments, safety profiles, and market alternatives in shaping prices and demand.
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