First generic of Vyvanse® launched in the United States

Vyvanse® (Lisdexamfetamine dimesylate), a schedule C-II controlled substance, was approved by the U.S. Food and Drug Administration (FDA) for treating attention-deficit/hyperactivity disorder (ADHD) in children in February 2007 and later in adults in 2008. In April 2018, the U.S. FDA expanded the approved indications of Vyvanse® (lisdexamfetamine dimesylate) to include treatment of moderate-to-severe binge-eating disorder (BED) in adults, making it the first drug approved to treat this disorder.

The drug in its last quarter of exclusivity raked in sales of 123 billion Japanese yen (about $880 million) for Takeda Pharmaceutical and was company’s third-largest drug in half of the last decade, amassing more than $2.5 billion in a year for the company. According to IQVIA, US sales of Vyvanse® were approximately $5.1 billion in the 12 months ending June 30, 2023.

Originally filed for ‘NRP104’ molecule by New River Pharmaceuticals (acquired by Shire Pharmaceuticals in February 2007 ) with a PCT number – PCT/US03/05525 in 2003, Vyvanse®’s molecule patent US7655630 ended it’s term in February 2023. However, due to an additional 6-month of paediatric exclusivity approved by FDA, Japanese drugmaker Takeda Pharmaceutical enjoyed a monopoly in the United States until August 2023.

The patent term expiry coupled with shortage of ADHD drugs like Adderall in the last 11 months (due to manufacturing delays by Teva Pharmaceutical) drove the priority review and approval of several first generics of Vyvanse®. The ANDAs approved by the US FDA on 25^th August 2023 for Vyvanse® include:

In a press release, Hikma Pharmaceuticals PLC announced that it has launched its generic version of Vyvanse® 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg capsules in the US on 31^st August 2023. It also mentioned that it is eager to work with the US Drug Enforcement Administration to obtain adequate supplies of raw materials that would enable Hikma to expediently use its strong US-based manufacturing and distribution capabilities to help address shortages of this essential medicine.