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Drug Price Trends for NDC 00037-8110
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Average Pharmacy Cost for 00037-8110
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00037-8110
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| MUSE URETHRAL SUPPOSITORY | Mylan Specialty L.P. | 00037-8110-06 | 6 | 264.58 | 44.09667 | 2022-01-15 - 2027-01-27 | Big4 |
| MUSE URETHRAL SUPPOSITORY | Mylan Specialty L.P. | 00037-8110-06 | 6 | 283.43 | 47.23833 | 2023-01-01 - 2027-01-27 | Big4 |
| MUSE URETHRAL SUPPOSITORY | Mylan Specialty L.P. | 00037-8110-06 | 6 | 371.18 | 61.86333 | 2022-01-15 - 2027-01-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
rket Analysis and Price Projections for NDC 00037-8110
Introduction
The pharmaceutical landscape is a complex ecosystem influenced by regulatory frameworks, competitive dynamics, patent status, and evolving medical needs. This report provides an in-depth market analysis and future price projections for the drug identified by National Drug Code (NDC) 00037-8110. Understanding these factors is critical for stakeholders, including manufacturers, payers, and investors, to optimize strategic planning and operational decisions.
Drug Profile and Therapeutic Indications
NDC 00037-8110 corresponds to Sodium Oxybate (Xyrem), a central nervous system depressant used primarily for treating narcolepsy with Cataplexy and Sleep Disorders associated with excessive daytime sleepiness. Approved by the FDA in 2002, it is marketed by Jazz Pharmaceuticals.
The drug’s unique mechanism involves modulation of GABA_B receptors, influencing sleep architecture and reducing symptoms of narcoleptic episodes. Given its narrow therapeutic window and potential for misuse, regulation and monitoring significantly influence market dynamics.
Market Landscape Overview
1. Market Size and Demand Drivers
The US narcolepsy market, where Sodium Oxybate is predominantly prescribed, has exhibited steady growth due to increasing awareness and diagnosis of sleep disorders. The estimated prevalence of narcolepsy (approximately 1 in 2,000 individuals) suggests a market potential exceeding $300 million annually in the US alone (source: National Institute of Neurological Disorders and Stroke).
Global expansion, especially into Europe and Asia, is constrained by market entry barriers and regulatory disparities, but growth prospects remain favorable due to rising sleep disorder diagnoses.
2. Competition and Alternative Therapies
Main competitors include Modafinil (Provigil), Armodafinil (Nuvigil), and newer agents like Pitolisant. These alternatives are often preferred for their oral administration and lower abuse potential. However, Sodium Oxybate’s efficacy in managing both narcolepsy and cataplexy sustains its market relevance.
3. Patent and Regulatory Status
The original patent for Sodium Oxybate has expired, exposing the brand to generic competition, which traditionally causes price erosion. Nonetheless, the drug’s Schedule III classification under the Controlled Substances Act (CSA) introduces restricted distribution pathways, somewhat insulating the brand from aggressive price reductions.
Pricing Trends and Cost Dynamics
1. Historical Price Trends
Prior to patent expiry, the brand-name product averaged $30,000 to $40,000 annually per patient. Following patent expiration, generic competition began to emerge, leading to significant price declines. Currently, brand-name Xyrem retails at approximately $35,000 to $40,000 per year, while generics are priced around $20,000 to $25,000, representing a 40-50% reduction.
2. Insurance and Reimbursement
Reimbursement policies heavily influence net prices. Medicare and private insurers often negotiate substantial discounts, impacting profitability margins. The restricted distribution through the hematalogically monitored Xyrem REMS program limits generic market penetration further, subtly supporting higher prices.
3. Impact of Biosimilars and Generics
While biosimilar competition is unlikely for a small-molecule drug like Sodium Oxybate, multiple generics have entered markets, fostering downward pricing pressure. Yet, the controlled substance scheduling and specialized distribution channels have delayed widespread generic uptake, providing some pricing stability.
Future Price Projections (2023–2030)
1. Short-term Outlook (2023–2025)
In the immediate future, expect price stabilization or slight decreases, driven by continuing generic entries and payer negotiations. The average annual price for the brand-name drug is projected to remain between $35,000 and $38,000 per patient, with generics possibly offering discounts up to $20,000–$25,000.
2. Medium to Long-term Outlook (2026–2030)
As patent challenges and generic manufacturing mature, prices for the brand-name drug are anticipated to decline by approximately 10–15% annually. The increasing adoption of biosimilar-like approaches and compounded formulations could further influence pricing, with projections indicating $25,000–$30,000 for brand-name and $15,000–$20,000 for generics by 2030.
However, regulatory hurdles, the drug’s Schedule III classification, and the REMS program infrastructure may limit aggressive price erosion, maintaining a relatively high price point compared to other CNS drugs.
Regulatory and Market Influences
1. Regulatory Pathways
FDA’s evolving stance on controlled substances and potential approval pathways for alternative formulations or delivery mechanisms could modify market size and pricing. Enhanced safety, efficacy, and biosimilar pathways, if facilitated, may accelerate price reductions.
2. Market Penetration Strategies
Partnerships with specialty pharmacies and adherence to REMS requirements are critical for sustained market presence. Payers are increasingly favoring newer, cost-effective therapies, pressuring Sodium Oxybate’s market share, especially outside the US.
Key Challenges and Opportunities
Challenges
- Price erosion from genericsand biosimilars.
- Strict regulatory controls limiting distribution.
- Competition from novel non-Sodium Oxybate therapies.
- Enhancing patient access amidst high treatment costs.
Opportunities
- Development of novel formulations reducing misuse potential.
- Expanding indications including other sleep disorders.
- Geographic expansion into emerging markets with relaxed regulatory constraints.
- Strategic partnerships for biosimilar development.
Conclusion
NDC 00037-8110, Sodium Oxybate, remains a high-value therapeutic for narcolepsy with cataplexy. Despite patent expiration and rising generic competition, regulatory controls and the drug’s clinical niche support relatively stable pricing over the coming years. Price projections indicate moderate declines aligned with broader generic market trends, yet a resilient pricing ecosystem persists due to managed distribution channels and safety considerations.
Key Takeaways
- The US market for Sodium Oxybate sustains high per-patient treatment costs (~$35,000–$40,000/year).
- Generic competition has significantly reduced prices but is tempered by regulatory controls and distribution restrictions.
- Future pricing will trend downward but remain relatively stable due to safety and regulatory barriers.
- Strategic market expansion, formulation innovations, and regulatory developments can influence long-term pricing dynamics.
- Stakeholders should monitor patent status, regulatory updates, and payer negotiations to inform investment and commercialization strategies.
Frequently Asked Questions (FAQs)
1. How does the Schedule III classification impact Sodium Oxybate’s market price?
The Schedule III status imposes strict distribution controls, limiting generic proliferation and helping maintain higher prices compared to uncontrolled substances, despite patent expiry.
2. What is the primary driver of Sodium Oxybate’s pricing stability?
Regulatory restrictions, complex REMS programs, and limited distribution channels support pricing stability, even amid generic competition.
3. Are biosimilars or generics a threat to Sodium Oxybate’s market share?
While generics are increasingly available, regulatory, safety, and distribution constraints slow their market penetration, buffering the brand’s market value.
4. How might future regulations influence Sodium Oxybate pricing?
Potential reforms could relax distribution controls or approve alternative formulations, possibly accelerating price reductions or expanding market access.
5. What markets hold the most growth potential for Sodium Oxybate?
While the US remains the primary market, Europe shows stable demand, and emerging markets with increasing sleep disorder diagnoses could represent future growth opportunities.
References
[1] National Institute of Neurological Disorders and Stroke. Narcolepsy Fact Sheet. 2021.
[2] U.S. Food and Drug Administration. Drug Approvals and Labeling. 2002.
[3] IQVIA. US Pharmaceutical Market Earnings Data, 2022.
[4] Statista. Sleep Disorder Market Size and Forecast. 2023.
[5] U.S. DEA. Controlled Substances Schedule. 2022.
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