White Paper: The first generic for Xyrem®

Posted on Posted in Blog, Pharmacy Benefits, Pharmacy Benefits Industry Updates

Xyrem InfographicSBG Perspectives – Generic for Xyrem® (Sodium Oxybate)

The first generic (made by Roxane) for Xyrem® was approved January 17, 2017 by the FDA. 1



– Gained approval in 2002 as an orphan drug marketed by Jazz Pharmaceuticals

– Used to treat cataplexy (weak or paralyzed muscles) attacks associated with narcolepsy; and/or reduce excessive daytime sleepiness in patients with narcolepsy2

– The only medication approved to treat cataplexy in patients with narcolepsy

– Because of its potential for abuse, sodium oxybate products are classified as Schedule

III Controlled Substances


  • Xyrem® is a medication that typically shows up on routine high dollar claimant reports.
    • Xyrem® can cost upward of $4,200 for a 180ml bottle, which for some patients (depending on their dose) can last up to 10 – 20 days
    • One claim could run as high as $8,400 – $16,800 for a 30 day supply
    • Exact pricing of the generic is not available at this time, but is anticipated to be about 20% – 30% lower than Xyrem®, until other generic competitors enter the market



  • Xyrem® is associated with several serious side effects (e.g., difficult breathing, seizures, coma, and even death) and has strict precautions for use
  • Like Xyrem®, the generic will also fall under strict safety controls on prescribing and dispensing by the FDA under the Risk Evaluation and Mitigation Strategy (REMS) program
    • Under REMS program, both Xyrem® and the generic can only be prescribed by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy3
    • Only a certified pharmacy that ships directly to patients can dispense sodium oxybate
    • Sodium oxybate will not be available in retail pharmacies


SBG Recommendations

Because of similar safety concerns with both Xyrem® and its generic, Payers may want to consider:

  • Utilization management edits that consider other effective and/or least costly alternatives for Xyrem® and/or its generic, when use is for excessive sleepiness associated with narcolepsy. Options may include methylphenidate, dexamphetamine, Provigil® (modafinil) or Nuvigil® (armodafinil)
  • A quantity limit across both Xyrem® and generic that does not allow more than 9 grams (18ml) per day
  • Preclusive edits that prevent unnecessary or intended therapeutic duplication of Xyrem® and/or its generic with methylphenidate, dextroamphetamine, Provigil®, Nuvigil®, or various other stimulant products


Prepared by:

Lynn Nishida, R.Ph.

Vice President



  1. FDA website. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/

ucm332408.htm? source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed January 18, 2017.

  1. Xyrem® [package insert]. Palo Alto CA: Jazz Pharmaceuticals; April 2015.
  2. The Xyrem REMS Program. https://www.xyrem.com/getting-xyrem/. Accessed January 18, 2017.



About Solid Benefit Guidance, LLC

Headquartered in Montvale, New Jersey, Solid Benefit Guidance (SBG) was founded over 10 years ago with the vision of providing health plans, and state and local governments with the opportunity to work with a consulting partner who truly understood the inner workings of the Pharmacy Benefit Management (PBM) industry. SBG has seen tremendous success in our ten-year history. SBG has managed over 40 million members and we are considered one of the nation’s most prestigious pharmacy benefit consultancy firms. Our success and industry reputation is based on our ability to provide clients with an unparalleled pharmacy benefit evaluation and strategies, actionable information and insight, clinical guidance, and a best in class service experience, which set us apart from the competition.


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