Last updated: July 28, 2025
Introduction
NDC 50268-0816 refers to a specific pharmaceutical product registered under the National Drug Code (NDC) system maintained by the FDA. Precise details about this product—such as its drug class, formulation, and indications—are crucial for comprehensive market analysis and price projection. Based on publicly available data, NDC 50268-0816 corresponds to Xywav (calcium, magnesium, sodium, and potassium oxybates), a controlled substance used primarily for treating narcolepsy and cataplexy. As a recent innovative treatment, its market dynamics and pricing are shaped by regulatory, clinical, and competitive factors.
Product Overview
Xywav was approved by the FDA in July 2021 as a modified-release oxybate formulation, intended for narcolepsy and idiopathic hypersomnia (IH). It is marketed by Jazz Pharmaceuticals and is a successor to Xyrem (also oxybate-based), with a distinct regulatory classification and pricing strategy designed to improve tolerability and safety profiles.
Market Landscape
1. Market Size and Demand Drivers
The narcolepsy market in the U.S. is estimated to be approximately $750-900 million annually, with narcolepsy affecting roughly 135,000–200,000 Americans [1]. The total market potential for oxybate-based therapies like Xywav hinges on several factors:
- Disease prevalence: Narcolepsy affects about 1 in 2,000 individuals, with most cases underdiagnosed or misdiagnosed.
- Treatment penetration: An estimated 50% of diagnosed patients are prescribed oxybate therapies, reflecting underutilization due to concerns about side effects and abuse potential.
- Off-label and dual indications: Use in idiopathic hypersomnia extends the market scope, further expanding revenue potential.
2. Competitive Dynamics
The primary competitor is Xyrem (sodium oxybate), also marketed by Jazz Pharmaceuticals. Although Xywav offers an improved formulation with a lower sodium content—a critical benefit for cardiovascular health—its market share is gradually increasing. Other competitors include modafinil and solriamfetol, which address wakefulness but do not target narcolepsy directly.
3. Regulatory and Reimbursement Environment
Regulatory agencies have enforced strict controls on oxybates due to their classification as Schedule III substances, posing distribution challenges but also ensuring consistent demand among prescribers authorized to prescribe such medications. Reimbursement policies, including Medicare and private insurers, are favorable for established brands, though formulary placement significantly impacts market share.
Pricing Analysis
1. Historical Pricing Trends
- Xyrem's wholesale acquisition cost (WAC) in 2022 was approximately $34,000–$36,000 per year per patient.
- Xywav launched at a similar price point but positioned as a valued alternative owing to its lower sodium content, aligning with broader health trends emphasizing cardiovascular safety and reducing pill burden.
2. Current Price Projections
Given the limited availability of data and assuming market trends:
- Initial retail price: Approximately $35,000–$38,000 annually per patient.
- Pricing trajectory: Expected to stabilize or slightly decline over the next 2-3 years due to increased generic competition, payer negotiations, and potential formulary inclusions.
- Dose and usage-related variation: The final annual cost depends on prescribed dosage; typical maintenance doses range between 4.5 to 9 grams nightly, influencing total expenditure.
3. Future Pricing Dynamics
- Market penetration: As usage expands from narcolepsy to include idiopathic hypersomnia, demand may increase 10-15%, supporting sustained premium pricing.
- Generics and biosimilar entry: While no biosimilars currently exist for oxybate formulations, patent protections extending until 2028 may delay price erosion.
- Market pressures: Payor push for cost-effective treatments could induce slight price reductions, especially if alternative therapies gain efficacy or safety profiles comparable to Xywav.
Price Projection Model (2023–2027)
| Year |
Estimated Average Price (per year) |
Key Assumptions |
| 2023 |
$36,000 |
Stable pricing, initial growth in market penetration |
| 2024 |
$35,500 |
Slight downward pressure from negotiations and competition |
| 2025 |
$34,500 |
Increased competition, payor leverage |
| 2026 |
$33,500 |
Potential entry of generics, more formulary restrictions |
| 2027 |
$32,500 |
Market saturation, continued price stabilization |
Note: These figures are speculative and based on current market trends, regulatory landscape, and competitive factors.
Key Market Opportunities and Challenges
Opportunities
- Expansion into idiopathic hypersomnia extends market potential.
- Growing awareness around cardiovascular safety enhances demand.
- Strategic partnerships with payers and specialty pharmacies can improve access.
Challenges
- Stringent regulatory controls restrict distribution channels.
- Increasing availability of generic oxybate formulations may exert downward price pressure.
- The risk of diversion and misuse remains a legislative concern, affecting prescribing patterns.
Conclusion
NDC 50268-0816, representing Xywav, occupies a niche in the specialized sleep disorder market, with significant revenue potential driven by therapeutic necessity, regulatory constraints, and clinical advantages. While current pricing remains high, projections indicate a gradual decline driven by market competition and evolving healthcare policies. The product’s success will depend on its ability to expand indications, navigate regulatory hurdles, and maintain strong payer relationships.
Key Takeaways
- Xywav commands a premium price comparable to its predecessor, Xyrem, due to its improved safety profile and niche positioning.
- The market size for oxybate therapies is constrained but maintains growth potential through expanding indications and increased diagnosis rates.
- Price projections suggest a slight decline over five years, influenced by generic competition and payor negotiations.
- Strategic collaborations and patient access programs could bolster market share and revenue stability.
- Regulatory and legislative risks remain, requiring vigilant compliance and marketing strategies.
FAQs
1. What factors influence the future pricing of NDC 50268-0816?
Pricing is affected by competition from generics, rebate and negotiation strategies with payers, regulatory approvals for new indications, and evolving safety profiles that may justify premium pricing.
2. How does the sodium content reduction in Xywav impact its marketability?
The lower sodium content positions Xywav as a safer alternative for cardiovascular health, enhancing its appeal among clinicians and patients concerned about hypertension and related comorbidities.
3. What is the primary regulatory concern surrounding oxybate formulations?
Due to their high abuse potential, oxybates are classified as Schedule III substances, imposing strict distribution, prescribing, and monitoring requirements that influence market access.
4. Which demographic segments are driving demand for oxybate products like Xywav?
Middle-aged adults with narcolepsy and related sleep disorders represent the primary demographic, alongside pediatric and geriatric populations requiring specialized management.
5. How might upcoming healthcare policies affect the market for NDC 50268-0816?
Policy shifts emphasizing value-based care, drug affordability, and safety could lead to increased scrutiny and negotiation leverage for payers, impacting pricing and access.
Sources:
[1] National Institutes of Health. Narcolepsy Fact Sheet. (2022)
