Hikma Pharmaceuticals’s wholly owned US subsidiary West-Ward Pharmaceuticals, has launched Ritonavir Tablets USP, 100 mg, the first AB-rated generic to Norvir tablets.
According to the FDA product approval letter, West-Ward is eligible for 180 days of generic drug exclusivity.
West-Ward’s ritonavir is approved by FDA for use in combination with other antiretroviral agents for treatment of human immunodeficiency virus (HIV-1) infection.
Brian Hoffmann, President, Generics Division, said, “We are very excited to be launching Ritonavir Tablets USP. This is an exciting product which demonstrates the successful execution of our strategy to develop differentiated products. We will be launching ritonavir with additional patient support and co-pay assistance to ensure more people are able to access this life-saving medicine.”
West-Ward understands that this is a very unique market that requires special consideration. It is engaging with advocacy groups to better understand how to communicate and support patients and healthcare providers. West-Ward is also launching an education and awareness campaign, including a website and direct communication, Hikma said in its press release.
According to IQVIA, US sales of Norvir were approximately $208.5 million in the 12 months ending December 2017.