Last updated: February 13, 2026
What is the current market position of drug NDC 13517-0694?
The drug identified by NDC 13517-0694 is Solriamfetol, marketed as Sunosi. Approved by the U.S. Food and Drug Administration (FDA) in 2019, Sunosi is indicated for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea (OSA). As of the latest data, the drug has a significant presence within the sleep disorder treatment segment, with controlled distribution and marketing channels largely dominated by Jazz Pharmaceuticals.
How does the current price of Sunosi compare to competing therapies?
The average wholesale price (AWP) for Sunosi is approximately $10.68 per tablet[1]. Treatment typically involves once-daily administration, with daily treatment costs around $320 for a 30-day supply. The key competitors include:
- Modafinil (Provigil)—averages $10–$15 per tablet, depending on dosage.
- Armodafinil (Nuvigil)—approximately $14 per tablet.
- Sodium oxybate (Xyrem)—costs exceeding $60 per gram; total costs for treatment span thousands of dollars monthly.
While Sunosi’s price aligns with certain wakefulness-promoting agents, its positioning aims at an alternative profile with fewer side effects and less abuse potential.
What are the sales and market projections for Sunosi over the next five years?
Market projections suggest steady growth for Sunosi, driven by increased diagnoses of sleep disorders and a shift towards personalized medicine. Current sales figures indicate approximately $211 million in revenue in 2022[2]. Industry analysts forecast this to grow at a compound annual growth rate (CAGR) of about 10% through 2027, reaching approximately $350 million by 2027.
Factors influencing projections include:
- Increased awareness and diagnosis of narcolepsy and OSA.
- Expanded insurance coverage and formulary inclusion.
- Potential approval for additional indications such as shift work disorder.
However, competition from generic formulations of modafinil and armodafinil could constrain growth and exert downward pressure on prices.
What are the key drivers and risks affecting the market valuation?
Drivers:
- Rising prevalence of sleep disorders.
- Growing acceptance of pharmacotherapy over behavioral approaches.
- Advances in pharmacokinetics improving compliance and side effect profiles.
Risks:
- Presence of more affordable generics replacing branded Sunosi.
- Regulatory challenges or label expansions for competing drugs.
- Potential adverse event profiles impacting payer and prescriber preferences.
How might pricing evolve over the coming years?
Pricing is likely to stabilize, with occasional adjustments influenced by competitive pressures and inflation. The entry of generics could prompt price reductions of approximately 20–40% within three to five years post-patent expiration, expected around 2026–2028. Market exclusivity for Sunosi persists until then, maintaining higher price points.
The combination of these factors suggests a cautious outlook: incremental growth with the potential for considerable decline in competitive pricing post-patent expiry.
Key Takeaways
- Sunosi (NDC 13517-0694) commands a premium price, averaging $10.68 per tablet, with annual costs around $4,000 per patient.
- Sales are growing at approximately 10% CAGR, projected to reach $350 million by 2027.
- Market expansion hinges on increased diagnosis rates, formulary inclusion, and provider acceptance.
- Price pressure from generics is anticipated in the next three years, likely reducing prices by up to 40%.
- Emerging indications and improved patient outcomes could sustain revenue growth, despite competitive threats.
FAQs
1. When do patent protections for Sunosi expire?
Patent protections are expected to expire around 2026–2028, allowing generic competitors to enter the market.
2. Are there any approved off-label uses for Sunosi?
No, current FDA-approved indications are for narcolepsy and obstructive sleep apnea.
3. How does Sunosi’s side effect profile compare to competitors?
Sunosi generally has a lower abuse potential and fewer stimulant-related side effects than traditional stimulants like modafinil, but side effects such as nausea and headache are common.
4. What is the potential of Sunosi in markets outside the U.S.?
Regulatory approval outside the U.S. is under review or pending in several countries, but current sales are primarily U.S.-focused.
5. What strategies could sustain Sunosi’s market share post-generic entry?
Differentiation through expanded indications, combination therapies, or improved formulations could preserve some market share.
Sources:
[1] Redbook, IMS Health, 2023.
[2] IQVIA, 2022 data.
