PDL BioPharma is introducing an authorized generic of Tekturna (aliskiren hemifumarate) in 150-mg and 300-mg tablets.
The product is indicated for the treatment of hypertension in adults and children 6 years old and older.
The launch is being carried out by Prasco, under an agreement with PDL's subsidiary, Noden Pharma.
Noden will continue to manufacture and commercialize prescription aliskiren products under the Tekturna and Tekturna HCT (aliskiren and hydrochlorothiazide) brands in the United States, and the Rasilez and Rasilez HCT brands in international markets. The authorized generic launch does not include Tekturna HCT.
"We believe being first-to-market with a generic version of aliskiren provides Noden with a distinct competitive advantage, especially given the market and brand recognition for Tekturna that the Noden team established with its promotional activities over the past two years," PDL president and CEO Dominique Monnet said. "We are very pleased to partner with Prasco, the recognized leader in the commercialization of authorized generics in the U.S. Together we look forward to continuing to fulfill the needs of U.S. patients who depend on Tekturna for the control of their blood pressure."
Tekturna products had a market value of $45.1 million, for the 12 months ended Sept. 30, 2018, with approximately 79% of sales for Tekturna and 21% for Tekturna HCT.