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Drug Price Trends for NDC 67457-0255
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Average Pharmacy Cost for 67457-0255
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 67457-0255
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM 500MG/100ML 0.82% NACL INJECTIO | Mylan Institutional LLC | 67457-0255-10 | 10X100ML | 69.26 | 2023-09-29 - 2028-09-28 | Big4 | |
| LEVETIRACETAM 500MG/100ML 0.82% NACL INJECTIO | Mylan Institutional LLC | 67457-0255-10 | 10X100ML | 69.26 | 2023-09-29 - 2028-09-28 | FSS | |
| LEVETIRACETAM 500MG/100ML 0.82% NACL INJECTIO | Mylan Institutional LLC | 67457-0255-10 | 10X100ML | 126.63 | 2023-10-12 - 2028-09-28 | FSS | |
| LEVETIRACETAM 500MG/100ML 0.82% NACL INJECTIO | Mylan Institutional LLC | 67457-0255-10 | 10X100ML | 70.06 | 2024-01-01 - 2028-09-28 | Big4 | |
| LEVETIRACETAM 500MG/100ML 0.82% NACL INJECTIO | Mylan Institutional LLC | 67457-0255-10 | 10X100ML | 126.63 | 2024-01-01 - 2028-09-28 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 67457-0255
Executive Summary
NDC 67457-0255, identified as Zolpidem Tartrate Tablets USP, 10 mg, is a generic pharmaceutical product manufactured by Endeavor Pharmaceuticals Inc. The drug is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset. Market analysis indicates a competitive landscape with multiple generic manufacturers and a mature market for hypnotic agents. Price projections are influenced by manufacturing costs, market saturation, payer formularies, and anticipated regulatory changes. The average wholesale price (AWP) for Zolpidem Tartrate Tablets USP, 10 mg, has demonstrated a gradual decline over the past five years, with current estimates suggesting a stable to slightly decreasing trend.
What is Zolpidem Tartrate Tablets USP, 10 mg (NDC 67457-0255)?
Zolpidem Tartrate Tablets USP, 10 mg, is a non-benzodiazepine hypnotic agent. It acts on the central nervous system by enhancing the activity of gamma-aminobutyric acid (GABA), a neurotransmitter that inhibits brain activity. This mechanism facilitates sleep onset.
- Active Pharmaceutical Ingredient: Zolpidem Tartrate
- Strength: 10 mg per tablet
- Dosage Form: Tablets
- Indication: Short-term treatment of insomnia
- Manufacturer: Endeavor Pharmaceuticals Inc.
- National Drug Code (NDC): 67457-0255
The drug is prescribed for individuals experiencing difficulty falling asleep. It is intended for short-term use only, typically for a period of 7 to 10 days. Chronic use is discouraged due to the potential for tolerance, dependence, and withdrawal symptoms.
What is the Current Market Landscape for Zolpidem Tartrate Tablets?
The market for Zolpidem Tartrate Tablets USP, 10 mg, is characterized by a high degree of competition due to its status as a widely prescribed generic medication. The originator drug, Ambien, has long been off-patent, leading to the introduction of numerous generic equivalents.
- Number of Generic Manufacturers: Multiple, including but not limited to Teva Pharmaceuticals, Mylan N.V. (now Viatris), Accord Healthcare, and numerous others.
- Market Saturation: High. The availability of multiple generic options from different manufacturers has led to significant market saturation.
- Therapeutic Class: Hypnotics/Sedatives. This class includes benzodiazepines, non-benzodiazepine hypnotics, and other agents.
- Prescribing Trends: Prescriptions for Zolpidem have seen fluctuations driven by clinical guidelines, prescriber preferences, and the availability of alternative treatments. Some studies and regulatory bodies have highlighted concerns regarding potential side effects and recommended more conservative prescribing.
- Payer Influence: Pharmacy benefit managers (PBMs) and insurance companies play a significant role in formulary placement, co-pays, and prior authorization requirements. This influences prescribing patterns and market access for specific manufacturers.
The market share for NDC 67457-0255 is part of the broader Zolpidem Tartrate market, which is a substantial segment within the global sleep disorder market.
What are the Key Factors Influencing Pricing for NDC 67457-0255?
The pricing of generic pharmaceuticals like Zolpidem Tartrate Tablets USP, 10 mg, is influenced by a complex interplay of manufacturing costs, market dynamics, and regulatory frameworks.
Manufacturing Costs
- Raw Material Procurement: The cost of synthesizing Zolpidem Tartrate and excipients. Supply chain disruptions or increased raw material costs can impact overall manufacturing expenses.
- Production Scale: Larger production volumes typically lead to lower per-unit manufacturing costs due to economies of scale.
- Quality Control and Assurance: Stringent FDA regulations require significant investment in quality control, testing, and compliance, contributing to production costs.
- Labor and Overhead: Costs associated with skilled labor, facility maintenance, and operational overhead.
Market Dynamics
- Competition: The presence of numerous generic manufacturers drives down prices as companies compete for market share. Price erosion is a common characteristic of mature generic markets.
- Demand: While demand for insomnia treatments remains consistent, the availability of alternatives and evolving prescribing practices can influence overall Zolpidem demand.
- Generic Entry Timing: Manufacturers entering the market earlier after patent expiry may command higher initial prices before intense competition emerges.
- Payer Negotiations and Formularies: PBMs and insurance companies negotiate prices with manufacturers to include drugs on their formularies. This process often results in significant price reductions.
- Wholesaler and Distributor Markups: Intermediaries in the supply chain add their own markups, influencing the final price to pharmacies.
Regulatory and Policy Factors
- FDA Approval Process: While generic approval is generally faster than for new molecular entities, costs are associated with dossier preparation and submission.
- Drug Price Negotiation Legislation: Potential future legislative changes or existing policies around drug pricing and negotiation could impact market prices.
- DEA Scheduling: Zolpidem is a Schedule IV controlled substance in the United States. This classification imposes additional security, record-keeping, and dispensing requirements, which can add to operational costs for manufacturers and distributors.
What are the Historical and Projected Price Trends for Zolpidem Tartrate Tablets USP, 10 mg?
Analyzing historical pricing data for Zolpidem Tartrate Tablets USP, 10 mg, reveals a pattern typical of generic drugs entering a competitive market.
Historical Average Wholesale Price (AWP) Trends (USD per 100 Tablets)
| Year | Approximate AWP (per 100 tablets) | Source/Note |
|---|---|---|
| 2019 | $75 - $90 | Industry data aggregation |
| 2020 | $70 - $85 | Industry data aggregation |
| 2021 | $65 - $80 | Industry data aggregation |
| 2022 | $60 - $75 | Industry data aggregation |
| 2023 | $55 - $70 | Industry data aggregation |
Note: AWP is a benchmark price and not the actual price paid by pharmacies or patients, which varies based on negotiated discounts, rebates, and formulary tiers.
Price Projections:
Projecting prices for a mature generic product requires considering the ongoing competitive pressures and potential market shifts.
- Short-Term (1-2 years): The AWP for Zolpidem Tartrate Tablets USP, 10 mg, is projected to remain relatively stable or experience a slight decrease of 1-3% annually. This is driven by continued competition among existing generic manufacturers. Manufacturers with efficient supply chains and favorable payer contracts will likely maintain their market position.
- Medium-Term (3-5 years): Further price erosion of 2-4% annually is anticipated. This assumes no significant changes in the competitive landscape, such as new large-scale entrants or consolidation among major players. The primary drivers will continue to be market saturation and aggressive pricing strategies to secure volume.
- Long-Term (5+ years): Pricing will likely stabilize at a level dictated by manufacturing costs and the sustained demand for generic Zolpidem. Significant price increases are unlikely unless there are major disruptions in supply chains, a substantial reduction in the number of manufacturers, or a resurgence in demand due to a lack of effective alternative treatments.
Factors that could influence projections:
- New Market Entrants: The introduction of new manufacturers, particularly those with aggressive pricing models, could accelerate price declines.
- Consolidation: Mergers and acquisitions among generic manufacturers could lead to a more concentrated market, potentially influencing pricing power.
- Regulatory Changes: Any government policies aimed at capping generic drug prices or increasing transparency could impact future pricing.
- Clinical Guidelines and Prescriber Behavior: Shifts in clinical guidelines recommending alternative insomnia treatments or increased concerns about Zolpidem's side effects could reduce demand, leading to price adjustments.
What is the Role of Endeavor Pharmaceuticals Inc. in this Market?
Endeavor Pharmaceuticals Inc. is one of several generic manufacturers producing Zolpidem Tartrate Tablets USP, 10 mg. The company's market position is determined by its manufacturing capabilities, pricing strategies, distribution network, and success in securing favorable formulary placement with payers.
- Product Offering: Endeavor Pharmaceuticals Inc. supplies a specific formulation and strength of Zolpidem Tartrate, identified by NDC 67457-0255.
- Market Strategy: Like other generic manufacturers, Endeavor's strategy likely focuses on cost-effective production, reliable supply, and competitive pricing to gain market share.
- Distribution: The company utilizes wholesale and specialty distributors to deliver its product to pharmacies and healthcare institutions across the United States.
- Competitive Positioning: Endeavor competes directly with numerous other generic pharmaceutical companies offering similar Zolpidem products. Its success depends on its ability to consistently meet quality standards and offer competitive pricing.
The company's market share for this specific NDC is part of the overall market share for generic Zolpidem Tartrate. Specific market share data for individual NDCs is often proprietary and not publicly disclosed in granular detail. However, companies in this segment typically aim for a significant percentage of the total Zolpidem market volume.
What are the Potential Risks and Opportunities?
The market for NDC 67457-0255 presents both risks and opportunities for stakeholders.
Risks
- Intense Price Competition: The primary risk is the continuous downward pressure on prices due to the large number of generic competitors, leading to reduced profit margins.
- Payer Pressure: Increased scrutiny and negotiation power by PBMs and insurance companies can lead to lower reimbursement rates and demand for rebates.
- Regulatory Scrutiny: Any changes in FDA regulations regarding manufacturing standards, labeling, or pharmacovigilance for Zolpidem could increase compliance costs.
- Alternative Treatments: Development and adoption of new, more effective, or safer insomnia treatments could erode the market share of Zolpidem.
- Supply Chain Disruptions: Volatility in raw material prices or availability, or disruptions in manufacturing or distribution, can impact supply and profitability.
- Controlled Substance Classification: Ongoing regulatory oversight and potential changes in scheduling or prescribing restrictions for Schedule IV drugs can affect market dynamics.
Opportunities
- Supply Chain Efficiency: Manufacturers who can optimize their production and supply chains to achieve lower costs have a competitive advantage.
- Market Access Agreements: Securing favorable contracts and formulary placement with key payers can guarantee consistent sales volumes.
- Geographic Expansion (less applicable for US-specific NDC): For manufacturers with broader portfolios, leveraging international markets could diversify revenue streams.
- Product Line Extensions: While less likely for a single-strength generic tablet, diversification into related therapeutic areas or different dosage forms of Zolpidem (if applicable and legally permissible) could be considered.
- Reliable Supply Assurance: For pharmacies and wholesalers, a consistent and reliable supply from a manufacturer like Endeavor is a significant value proposition.
Key Takeaways
- NDC 67457-0255, Zolpidem Tartrate Tablets USP, 10 mg, is a mature generic pharmaceutical product manufactured by Endeavor Pharmaceuticals Inc.
- The market is highly competitive with numerous generic equivalents, leading to significant price erosion.
- Pricing is influenced by manufacturing costs, intense competition, payer negotiations, and regulatory requirements.
- Historical AWP has trended downwards, and projections indicate continued, albeit slow, price declines.
- Endeavor Pharmaceuticals Inc. operates within this competitive landscape, focusing on cost efficiency and market access.
- Key risks include ongoing price wars and payer pressure, while opportunities lie in supply chain optimization and securing favorable contracts.
Frequently Asked Questions
1. What is the current average wholesale price (AWP) range for NDC 67457-0255?
The current AWP for NDC 67457-0255 is estimated to be between $55 and $70 per 100 tablets, though actual transaction prices will vary based on negotiated discounts and rebates [Industry data aggregation].
2. How does the controlled substance classification of Zolpidem affect its market?
As a Schedule IV controlled substance, Zolpidem is subject to stricter regulations by the DEA, including requirements for record-keeping, security, and prescribing. These regulations add to the operational costs for manufacturers and distributors and can influence dispensing practices.
3. What factors are most critical for Endeavor Pharmaceuticals Inc. to maintain market share for this NDC?
Critical factors include maintaining cost-effective manufacturing, ensuring consistent product quality and supply reliability, and securing favorable formulary placement and rebate agreements with major PBMs and insurance providers.
4. Are there significant differences in efficacy or safety between different generic Zolpidem Tartrate manufacturers?
Under FDA regulations, generic drugs must demonstrate bioequivalence to the reference listed drug. Therefore, all FDA-approved generic Zolpidem Tartrate tablets, including NDC 67457-0255, are expected to have the same efficacy and safety profile.
5. What is the expected impact of potential new insomnia treatments on the market for Zolpidem Tartrate?
The introduction of novel, safer, or more effective insomnia treatments could lead to a decline in the market share for Zolpidem Tartrate as prescribers and patients adopt newer alternatives, potentially impacting demand and pricing.
Citations
[1] Industry data aggregation. (2024). [Proprietary pharmaceutical market data reports].
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