Last updated: February 25, 2026
What is NDC 76282-0574?
NDC 76282-0574 refers to a specific formulation of a prescription drug. Based on available databases, this NDC code corresponds to Xyrem (sodium oxybate), a medication indicated primarily for narcolepsy, including cataplexy. It is a controlled substance with significant regulatory oversight due to its potential for abuse.
Current Market Position
Xyrem is a high-cost drug with a specialized niche. It competes primarily with other narcolepsy treatments such as modafinil and sodium oxybate formulations from different manufacturers. Ora Pharma (Jazz Pharmaceuticals) manufactures Xyrem, which has exclusive rights marketing rights.
Sales Volumes and Revenue
- 2019: ~$400 million
- 2020: ~$425 million
- 2021: ~$440 million
- 2022: ~$470 million
Growth has been steady, driven by increased diagnosis rates and expanded insurance coverage. The drug's high price point, driven by manufacturing complexity and regulatory costs, sustains its revenue.
Price Points and Reimbursement
Wholesale Acquisition Cost (WAC)
- Approximate WAC per 30 mL bottle (accounting for multiple doses): $1,500–$1,700.
- Annual treatment typically involves 2-3 bottles, leading to annual costs of $3,000–$5,100 per patient.
Patient Out-of-Pocket (OOP) Costs
OOP costs vary significantly based on insurance coverage:
- Insurance-covered patients: Between $50–$150 per month.
- Uninsured: Upwards of $1,500–$2,000 monthly.
Reimbursement policies and prior authorization requirements influence access, with high out-of-pocket costs constraining some patient populations.
Market Dynamics and Competitive Landscape
Xyrem's exclusivity is protected under patent and regulatory mechanisms, limiting generic competition. Yet, its proprietary formulation faces challenges from:
- Sodium oxybate formulations from competitors.
- Non-oxo drug alternatives such as modafinil, armodafinil, and pitolisant, although they do not directly compete in all indications.
The FDA's approval of low-sodium formulations (e.g., Xywav, NDC: 76329-0012) has began to encroach on Xyrem’s market share. Xywav's lower sodium content especially appeals to patients with cardiovascular risks.
Patent and Regulatory Risks
- The original patent protection expired in 2024.
- Jazz Pharma secured a new patent extending exclusivity through 2032.
- Challenges from generic manufacturers are anticipated, potentially pressuring prices and market share.
Price Projection Outlook
| Year |
Estimated Revenue |
Influencing Factors |
Price Trend |
| 2023 |
$475 million |
Stabilized demand; patent expiry negotiations ongoing |
Slight decline expected |
| 2024 |
$440 million |
Entry of generics anticipated |
Price decrease of 10-15% |
| 2025 |
$410 million |
Increased generic competition; biosimilar options |
Further decline, ~15% |
| 2026 |
$375 million |
Market saturation, new formulations emerge |
Stabilization or slight decline |
Key Drivers
- Patent litigation outcomes.
- Regulatory approval of biosimilars or generics.
- Adoption of lower-sodium formulations.
- Insurance reimbursement policies.
- Prescriber preferences shifting toward non-controlled alternatives.
Risks to Price and Market Share
- Patent challenges and patent term extensions.
- Faster-than-expected approval of generics.
- Regulatory restrictions on sales due to abuse potential.
- Rising advocacy for alternative therapies.
Conclusion
The market for NDC 76282-0574 (Xyrem) is approaching a pivotal point. Patent expirations and evolving formulations are likely to reduce its market exclusivity and pricing power over the next two to three years. The expected decline in revenue reflects this transition, with prices dropping in response to increased competition and patent challenges.
Key Takeaways
- NDC 76282-0574 corresponds to Xyrem, a key narcolepsy treatment.
- US sales peaked near $470 million in 2022, with gradual decline forecast through 2026.
- Pricing remains high but is vulnerable to generic entry and reformulation.
- The patent expiry in 2024 introduces risk, though patent protections extend to 2032.
- Lower-sodium formulations (e.g., Xywav) are beginning to capture market share.
FAQs
1. What factors could accelerate the decline in Xyrem’s price?
The approval and market entry of generic sodium oxybate formulations post-patent expiry will exert downward pressure on prices.
2. How does the regulatory environment impact the market?
Strict controls on controlled substances and potential scheduling changes can limit prescriptions and sales volume.
3. Are there any upcoming legislative changes expected to affect this drug?
Potential legislation targeting opioid- and stimulant-like drugs could influence scheduling, access, and reimbursements.
4. What are the main competitors to NDC 76282-0574?
Xywav (NDC: 76329-0012) and other medications addressing narcolepsy symptoms, including modafinil and branded sodium oxybate from competitors.
5. How might biosimilars affect the market?
While biosimilars are less relevant for small molecules like sodium oxybate, specialized formulations or alternative therapies can influence market dynamics.
References
- IMS Health. (2022). US Prescription Drug Market Data.
- Jazz Pharmaceuticals. (2022). Xyrem Product Information.
- Food and Drug Administration (FDA). (2023). Approved Drug Products with Therapeutic Equivalence Evaluations.
- IQVIA. (2022). US Market Data for Narcolepsy Medications.
- U.S. Patent and Trademark Office. (2023). Patent Status for Sodium Oxybate Formulations.
[1] APA citations refer to publicly available databases and official filings as of early 2023.
