Hikma Launches Authorised Generic Version Of Nucynta In The US, Expands Generics Portfolio

Hikma Pharmaceuticals PLC and its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. announced the launch of an authorised generic version of Nucynta® (tapentadol) in the United States. The introduction aims to expand patient access to this opioid analgesic therapy.

Tapentadol immediate-release tablets are indicated for the management of acute pain severe enough to require an opioid analgesic when alternative treatments are inadequate. The product is approved for use in adults and pediatric patients aged six years and older who weigh at least 40 kg. According to IQVIA data, Nucynta® generated approximately $157 million in gross sales in the 12 months ending December 2025.

Hafrun Fridriksdottir, President of Hikma Rx said, “We are pleased to launch this authorised generic, broadening our portfolio as we continue to provide millions of American patients with greater access to essential medicines.” 

With this launch, Hikma continues to strengthen its U.S. generics portfolio while supporting broader access to pain management options. The authorised generic provides an alternative to the branded product while maintaining the same active ingredient, dosage form, and therapeutic profile.

Headquartered in the United Kingdom, Hikma operates globally across North America, the Middle East and North Africa, and Europe. For more than four decades, the company has focused on developing and supplying high-quality branded and non-branded generic medicines to improve patient access to essential treatments.