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January 31, 2022

Extending Drug Monopolies by Patenting Safe Drug Use

Author Affiliations
  • 1Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
JAMA Intern Med. 2022;182(3):245-246. doi:10.1001/jamainternmed.2021.7954

In recent years, the price of the blockbuster narcolepsy drug sodium oxybate (Xyrem; Jazz Pharmaceuticals) has increased dramatically. Although its active ingredient was synthesized and tested in clinical trials more than 50 years ago,1 the list price for a 0.5-g/mL dose increased from $7.67 in the second quarter of 2011 to $36.96 in the first quarter of 2021 (382%). In 2020, Jazz Pharmaceuticals (Jazz) reported $1.7 billion in sales. In December 2025, the brand name drug may first face full competition from generic versions, 23 years after the US Food and Drug Administration (FDA) first approved it.2 Jazz has delayed generic entry after its last formulation patents expired in 2021 by updating drug safety labeling in a way that has helped block generic versions of the drug from entering the market.

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