Eli Lilly and Company has announced that the U.S. District Court for the Southern District of Indiana today issued a preliminary injunction to prevent the launch of a generic version of Lilly's medicine Evista (raloxifene HCl tablets) by Teva Pharmaceuticals until the Court renders its final ruling.
Teva had indicated it was prepared to launch the generic version prior to the resolution of outstanding patent litigation currently being considered by the U.S. District Court for the Southern District of Indiana. Lilly had previously sought and been granted a temporary restraining order to prevent the generic launch.
"We appreciate the Court issuing a preliminary injunction and ensuring that the intellectual property protection for Evista remains in place until the Court renders its final opinion," said Robert A. Armitage, senior vice president and general counsel for Lilly. "We believe Teva's challenges to Lilly's Evista patents are without merit and we expect to prevail in this litigation. We have taken and will continue to take all appropriate actions needed to protect our intellectual property rights as they relate to Evista."
Evista is a breakthrough medicine indicated for the treatment and prevention of osteoporosis in postmenopausal women; the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis; and the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. The validity of the product's 2012, 2014 and 2017 patents have been challenged and are currently being heard in the case of Eli Lilly and Company v. Teva Pharmaceuticals Industries Ltd.
Evista, a selective estrogen receptor modulator (SERM), recently classified by the FDA as an estrogen agonist/antagonist, is indicated for the treatment and prevention of osteoporosis in postmenopausal women; and the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.
Important Safety Information about Evista (raloxifene HCl tablets)
Evista is not for everyone. Serious side effects can occur while taking Evista.