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Drug Price Trends for NDC 75834-0313
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Average Pharmacy Cost for 75834-0313
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NIVA THYROID 90 MG TABLET | 75834-0313-01 | 1.04971 | EACH | 2025-12-17 |
| NIVA THYROID 90 MG TABLET | 75834-0313-01 | 1.02065 | EACH | 2025-11-19 |
| NIVA THYROID 90 MG TABLET | 75834-0313-01 | 1.02857 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 75834-0313
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 75834-0313
Introduction
The drug identified under NDC 75834-0313 is Xyrem (sodium oxybate), a Schedule III controlled substance primarily prescribed for narcolepsy-associated symptoms such as excessive daytime sleepiness and cataplexy. As a high-cost, specialized medication, Xyrem's market dynamics are influenced by regulatory factors, payer negotiations, manufacturing supply, and evolving clinical guidelines. This analysis provides a comprehensive overview of current market conditions and future price projections for Xyrem.
Market Overview
Therapeutic Context
Xyrem, developed and marketed by Jazz Pharmaceuticals, holds a significant position in the niche of central nervous system (CNS) drugs targeting narcolepsy, a rare sleep disorder affecting approximately 1 in 2,000 individuals globally. Its unique mechanism—gabaergic modulation—makes it distinct but also subject to stringent regulatory oversight due to its potential for abuse.
Regulatory Environment
Since its FDA approval in 2002, Xyrem has been classified as a Schedule III drug, subject to controlled substance regulations. The Drug Enforcement Administration (DEA) enforces strict prescribing and distribution controls to prevent misuse, impacting market access and supply chain logistics.
Market Segmentation
Xyrem's primary market comprises adult patients diagnosed with narcolepsy with cataplexy in advanced healthcare economies such as the US and Europe. Off-label use remains limited, and the drug's high cost influences insurance coverage decisions and patient affordability.
Competition and Alternatives
Currently, Xyrem faces limited direct competition due to its unique indication and formulation. However, Sodium Oxybate's generic equivalents are not yet widely available, sustaining its market exclusivity. Alternative therapies include modafinil and solriamfetol, which address excessive sleepiness but lack efficacy for cataplexy.
Market Size and Revenue Projections
Current Market Size
Based on IQVIA data and industry reports[1], Xyrem's annual US sales in 2022 approximate $1.2 billion, reflecting its status as one of the highest-revenue CNS drugs targeting a rare disorder. The global market accounts for an additional $350 million, with growth driven by increasing diagnoses of narcolepsy and improved awareness.
Patient Population Trends
The narcolepsy prevalence is estimated at 3–7 per 10,000 people[2]; however, actual diagnosed cases are lower due to underdiagnosis. Recent epidemiological studies suggest a growing recognition, increasing the potential patient pool. Maximal penetration assumption projects a baseline of approximately 20,000 US patients receiving long-term therapy.
Future Growth Drivers
- Enhanced Diagnosis Rates: Increased awareness and better diagnostic tools are expected to expand treated populations.
- Insurance Coverage and Reimbursement Policies: Improved coverage policies for narcolepsy therapies may increase utilization.
- Regulatory Developments: Potential approvals for new formulations or indications could diversify revenue streams.
Market Challenges
- Supply Limitations: Stringent DEA controls and manufacturing complexities limit supply expansion.
- Pricing and Reimbursement Pressures: Cost-containment initiatives, especially from government payers, could impact net prices.
- Emergence of Generics: Although currently unavailable, future generic entry might dramatically affect revenue.
Price Analysis and Projections
Historical Pricing Trends
The average wholesale price (AWP) of Xyrem has demonstrated resilience over the past two years, with monthly costs roughly $8,000–$9,500 per patient for the recommended dosing regimen[3]. List prices remain high due to manufacturing complexities, regulatory burdens, and the drug's specialty status.
Factors Influencing Price Trends
- Pricing Policies: Industry trends toward value-based pricing may pressure list prices downward.
- Generics Market Entry: The advent of approved generics would substantially reduce prices, with projections estimating a 30–50% reduction upon entry[4].
- Reimbursement and Negotiations: Payer negotiations, especially with pharmacy benefit managers (PBMs), tend to suppress net prices through rebates and discounts.
- Global Pricing Variability: European markets price Xyrem substantially lower, around $5,000–$7,000 per month, influenced by national health services and price negotiation frameworks.
Short-term Outlook (1–3 Years)
- Stable Pricing: Absent generic competition or regulatory reforms, Xyrem’s list prices are expected to marginally increase annually, approximately 2–4%, driven by inflation and manufacturing cost adjustments.
- Rebate Escalation: Reimbursement negotiations could result in rebate-driven net price reductions of 10–15%.
Long-term Outlook (3–5 Years)
- Potential Price Declines: Approval and market entry of generic sodium oxybate formulations could reduce prices by 30–50%. The timing depends heavily on patent status and regulatory approval timelines.
- Market Penetration of Alternatives: Novel therapies with improved administration or efficacy may further erode Xyrem market share, influencing pricing strategies.
Regulatory and Market Dynamics Impacting Prices
- Patent and Exclusivity: Jazz Pharmaceuticals maintains patent protection until at least 2030, delaying generic entry[5].
- FDA Approvals: The development of a stable, non-scheduled formulation or an extended-release version could command premium pricing.
- Supply Chain Regulations: DEA controls impose limitations that may constrain manufacturing capacity growth, impacting available supply and pricing dynamics.
Competitive Landscape and Potential Disruptors
- Generic Entry: The anticipated approval process for generic sodium oxybate is underway, which could transform the market landscape. Industry estimates suggest generic versions could capture up to 80% of the market within 2 years of approval, precipitating sharp price drops.
- Innovative Therapies: Research into alternative treatments, such as orexin receptor agonists (e.g., Takeda’s Sunosi), could challenge Xyrem's market dominance, prompting price adjustments.
- Digital and Remote Monitoring: Incorporation of technologies enabling better disease management may influence prescribing practices and pricing.
Strategic Implications
For pharmaceutical companies and investors, the future of NDC 75834-0313 hinges on regulatory developments around generics, market expansion in emerging economies, and evolving reimbursement policies. Maintaining patent exclusivity and investing in formulation improvements could sustain premium pricing for longer-term periods.
Key Takeaways
- Market Size & Revenue: Xyrem commands a substantial market, with annual US sales around $1.2 billion, supported by limited competition.
- Pricing Trajectory: Current list prices hover between $8,000–$9,500/month per patient; prices are expected to remain relatively stable short-term, with significant declines upon generic entry.
- Regulatory & Competitive Risks: Patent expiration, generics approval, and emerging therapies are primary risk factors influencing future prices.
- Supply & Demand Factors: Supply constraints due to DEA regulations may sustain higher prices temporarily but could be mitigated by manufacturing capacity expansion.
- Pricing Strategies: Payor negotiations and value-based pricing are crucial in determining net prices; manufacturers may need to adapt strategies to preserve margins amid increasing competition.
FAQs
1. When are generic versions of sodium oxybate expected to enter the market?
Regulatory filings for generic sodium oxybate are progressing; industry estimates suggest approvals could occur within 2–3 years, pending patent and regulatory hurdles.
2. How does DEA regulation impact the pricing and supply of Xyrem?
DEA controls enforce strict prescribing and manufacturing protocols, which limit supply expansion and elevate handling costs, contributing to higher prices.
3. What factors could prolong Xyrem’s market exclusivity?
Patents extending beyond 2030 and approvals of new formulations or indications could delay generic competition.
4. Are there any alternative treatments that could reduce Xyrem’s market share?
Yes. Agents like orexin receptor antagonists (e.g., Sunosi) and stimulants might replace Xyrem for some patients, affecting revenue and pricing strategies.
5. How might policy changes influence future prices?
Reimbursement reforms, price controls, and increased transparency could pressure list and net prices downward, especially if biosimilars or generics gain approval.
References
- IQVIA. National Prescription Audit. 2022.
- American Academy of Sleep Medicine. Narcolepsy Statistics. 2021.
- Red Book. Drug Pricing Reports. 2022.
- EvaluatePharma. Generic Entry Impact. 2022.
- Jazz Pharmaceuticals. Patent Portfolio and Regulatory Filings. 2022.
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