Jazz Pharmaceuticals has had an FDA approval in hand for sleepiness med Sunosi for months, but now it can start planning its official rollout. On Monday, the Drug Enforcement Agency tagged the drug with a Schedule IV designation, setting Jazz up for a launch next month.
Sunosi, approved to improve wakefulness in patients with excessive daytime sleepiness from narcolepsy or obstructive sleep apnea, will launch in early July, the company said in a release. Jazz will make the med available in 75-mg and 150-mg tablets.
The DEA scheduling “aligns with our research demonstrating this medicine's relatively low potential for abuse and risk of dependence,” Jazz CEO Bruce Cozadd said in a statement. As the company gets ready for the rollout, Jazz has planned an investor conference early next month to go over further details.
Jazz’s launch comes at an important time for the drugmaker as it has inked patent settlements allowing copycat launches to its big-selling narcolepsy med Xyrem in 2023. It’ll work to grow Sunosi sales by then—and analysts believe the new med has a shot at generating hundreds of millions of dollars annually in the coming years. Last year, Xyrem pulled in $1.4 billion.
Leerink analyst Ami Fadia has predicted Sunosi can generate more than $500 million by 2023, while RBC Capital Markets analyst Randall Stanicky has predicted 2024 Sunosi sales of $314 million. In a Monday note to clients, Wells Fargo analyst David Maris said the DEA scheduling was a positive for Jazz and said he believes the med can rack up $180 million in 2021.
Jazz planned to hire new sales reps ahead of Sunosi’s approval and started making job offers when it received the FDA nod. The company has also planned on a prelaunch disease awareness campaign and DTC advertising.