FDA Confirms Paragraph IV Patent Litigation for Elagolix Sodium, Estradiol, Norethindrone Acetate Capsules
In late July, Sangamo’s former R&D chief Adrian Woolfson, who left the biotech when it split its R&D, launched his own gene therapy outfit. Replay’s primary platform was an HSV vector which, as a hub-and-spoke biotech, it said it was building four different companies around.
Several drugmakers, including Sandoz and Teva, are banking on swift approvals for their generic versions of the endometriosis drug Orilissa — but not if AbbVie can help it.
AbbVie Inc. alleges in a federal lawsuit that copies of Orilissa proposed by nine generic-drug makers, including Novartis AG’s Sandoz Inc. and Lupin Ltd., infringe as many as six patents for the drug, used to manage pain associated with endometriosis.
FDA Confirms Paragraph IV Patent Litigation for Orilissa (Elagolix)
Enforcement Report - Week of June 2, 2021
Myovant $MYOV has been prepping relugolix for advanced prostate cancer over the last several months, looking to improve upon the old standard in AbbVie’s Lupron. But new data out Tuesday will not help its cause.
The U.S. Food and Drug Administration today granted approval to Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Most of the recent enthusiasm around AbbVie’s new drugs has centered on immunology meds Skyrizi and Rinvoq, but women’s health med elagolix—known commercially as Orilissa in endometriosis—wants a piece of the spotlight, too.
Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.