Eli Lilly and Company issued a communiqué after being granted a temporary restraining order to halt the launch of a generic version of Evista (raloxifene HCl tablets) by Teva Pharmaceuticals. Teva had indicated it was prepared to launch the generic version prior to the resolution of outstanding patent litigation currently being heard by the US District Court for the Southern District of Indiana.
"We appreciate the Court issuing the temporary restraining order and look forward to completing the trial and vindicating our patent rights," said Robert A Armitage, senior vice president and general counsel for Lilly. "We believe Teva's challenges to Lilly's Evista patent 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."
"At Lilly, our mission is to discover and develop innovative new medicines for patients. Respect for our patents is critical to that mission, as is our ability to enforce our patents against those who violate them."
Evista is a breakthrough medicine 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. 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.