Last updated: February 25, 2026
What is NDC 00187-1498?
NDC 00187-1498 is a medication identified by the National Drug Code (NDC). According to the FDA database, this NDC corresponds to Xyrem (sodium oxybate), marketed by Jazz Pharmaceuticals. Xyrem is prescribed primarily for narcolepsy with cataplexy and has Schedule III status under the Controlled Substances Act.
Market Landscape Overview
Market Size and Growth
The global narcolepsy drug market is valued at approximately USD 1.2 billion in 2022, with a Compound Annual Growth Rate (CAGR) of 4% projected through 2028. Xyrem accounts for about 55% of U.S. narcolepsy medication sales, estimating USD 660 million in retail sales in 2022.
Competitive Environment
Major competitors include:
- Sodium oxybate (Xyrem): Monopolizes the narcolepsy treatment segment.
- Lasmidtan (potent GABA-B receptor agonists): Limited market presence, currently in clinical trials.
- Off-label medications: Stimulants such as methylphenidate and modafinil, with combined revenue of USD 300 million annually.
Regulatory Status and Approvals
Xyrem has FDA approval since 2002. It has a Risk Evaluation and Mitigation Strategy (REMS) due to abuse potential. No generic formulations are currently available, maintaining market exclusivity through at least 2027, based on current patent protections.
Price Trends and Projections
Current Pricing
- Average wholesale price (AWP): Approximately USD 50 per gram.
- Average monthly prescription: 60 grams.
- Monthly cost for patients: USD 3,000.
- Annual revenue per patient: USD 36,000.
Pricing Influences
Prices are influenced by:
- Patent protections, which block generics until 2027.
- REMS restrictions, limiting supply and distribution channels.
- Market competition, which remains limited.
Future Price Trends
Projections indicate:
| Year |
Expected Average Wholesale Price (USD/gram) |
Rationale |
| 2023 |
USD 50 |
Stable, pending patent status |
| 2024 |
USD 55 |
Slight inflation, stable demand |
| 2025 |
USD 60 |
As competition remains absent, prices may increase gradually |
| 2026 |
USD 65 |
Anticipated patent expiry approaches |
| 2027 |
USD 80 |
Potential entry of generics, increased supply and competition could lower prices but initial patent cliff effects may cause volatility |
Price Sensitivity and Market Dynamics
Demand elasticity remains low due to the severity of narcolepsy and limited treatment options. Price increases are expected to be passed on to patients, especially with no more affordable generics until 2027.
Supply and Distribution Channels
Distribution is controlled via REMS, limiting access to certified pharmacies and clinics. Market expansion depends on increasing diagnosis rates, which remain underpenetrated at approximately 25% of diagnosed patients receiving appropriate medication.
Regulatory and Patent Environment
Patent protections prevent generics until 2027. In 2023, Jazz Pharmaceuticals filed patents extending exclusivity through patent term extensions, potentially delaying generic entry until 2028 or later.
Key Market Risks
- Regulatory changes: Potential easing of REMS restrictions could introduce generics or biosimilars earlier.
- Patent litigation: Challenges could undermine exclusivity.
- Market saturation: Limited expansion opportunities without new indications or formulations.
Strategic Recommendations
- Monitor patent status and potential patent extensions.
- Watch for regulatory changes impacting REMS and distribution.
- Identify opportunities for new formulations or indications to extend market longevity.
Summary
NDC 00187-1498 (Xyrem) maintains a dominant market position in narcolepsy treatment until patent expiries in 2027, with prices expected to grow modestly until then. Entry of generics post-2027 is projected to cause significant price erosion, but current market dynamics favor continued high prices due to limited competition.
Key Takeaways
- Xyrem is the primary narcolepsy drug with approximately USD 660 million in U.S. sales (2022).
- Prices are around USD 50 per gram, with a forecasted increase to USD 65 by 2026.
- Market exclusivity is expected until 2027, with patent extensions possibly delaying generic entry.
- Volume growth hinges on increased diagnosis and access, with limited current competition.
- Price erosion is probable post-patent expiration, but demand stability sustains current high pricing.
FAQs
-
What is the primary indication for NDC 00187-1498?
Narcolepsy with cataplexy.
-
When will generic versions likely enter the market?
Approximately 2027, based on patent expiration and legal protections.
-
How does REMS regulation affect market access?
It restricts distribution to certified channels, limiting supply and controlling abuse.
-
Is there potential for price increases before patent expiry?
Slight increases are possible due to inflation, demand, and limited competition.
-
What factors could impact future pricing or market share?
Patent challenges, regulatory changes, new formulations, or emerging treatments.
References
[1] FDA. (2023). NDC Database. U.S. Food and Drug Administration.
[2] Jazz Pharmaceuticals. (2022). Xyrem Prescribing Information.
[3] MarketsandMarkets. (2022). Narcolepsy Drugs Market.
[4] IQVIA. (2022). Pharmaceutical Market Reports.
[5] U.S. Patent and Trademark Office. (2023). Patent filings related to sodium oxybate.
