AbbVie puts up fight against Orilissa generics from Sandoz, Teva and others

2022-10-31

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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. The pharma giant filed suit against the generic competitors in Delaware federal court on Thursday, asserting several patents, the latest of which expire in 2036. Plaintiffs argued in a 167-page complaint that abbreviated NDAs submitted by the defendants have caused or will lead to “foreseeable harm and injury” to AbbVie. In addition to Sandoz and Teva, AbbVie targeted Sun Pharmaceutical, Alkem Laboratories, Hetero Labs, Lupin Pharmaceuticals, MSN Pharmaceuticals, Prinston Pharmaceutical, Zhejianh Huahai Pharmaceutical, Solco Healthcare, Zenara Pharma and Biophore India Pharmaceuticals, among others in the latest suit. Orilissa was first approved in 2018 for moderate to severe pain associated with endometriosis, a condition that occurs when estrogen levels rise during a woman’s menstrual cycle, causing lesions to grow outside of the uterus. Those lesions can shred during menstruation, causing pain. In some cases, patients develop fertility problems. Orilissa works by reducing the amount of estrogen produced by the body to help manage pain. The drug comes in two doses, 150mg and 200mg. The earliest patents covering the two doses expire in 2024, though AbbVie noted in the complaint that it has filed for an extension on at least one of those patents to 2029. Orilissa contributed to AbbVie’s $796 million women’s health business in 2021 — led by the contraceptive pill Lo Loestrin – though rumors swirled that year that AbbVie was considering a $5 billion sale of the portfolio. Former Allergan CEO Brent Saunders had initially laid out plans to offload the company’s women’s health and infectious disease units, but eventually decided to hold on to them. AbbVie later scooped them up in its $63 billion buyout. AbbVie wouldn’t be the first pharma giant to part ways with women’s health. Merck spun out its women’s health unit Organon, which accounted for $6.6 billion in 2020 sales, last June. Aside from potential generics, Orilissa competes with the Pfizer-partnered Myfembree, which was first approved last year to treat heavy menstrual bleeding with uterine fibroids, and snagged an additional indication in August for endometriosis pain.

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