Norethindrone/Ethinyl Estradiol

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.

© AbbVie Inc. All rights reserved. One year after AbbVie’s $63 billion purchase of Allergan, the company is reportedly lining up the sale of a portfolio of women’s drugs and health care products valued at $5 billion. This morning, citing unnamed sources “familiar with the matter,” Reuters reported the Illinois-based company plans to sell off the assets that it gained from the Allergan acquisition, which closed last year. Included in the potential sale is the Lo Loestrin Fe birth control pill, among others. he women’s health assets are expected to be sold through an auction process and Reuters said the plan is already attracting interest from multiple private equity firms, including CVC Capital Partners. One of CVC’s umbrella companies, Theramex, which was launched in 2018 after CVC acquired the international women’s health assets from Teva Pharmaceutical, markets several contraceptive products, including the birth control pills Zoely and Seasonique. Reuters’ sources said CVC could use the AbbVie birth control products to complement the existing Theramex portfolio. The AbbVie portfolio of assets that could be up for sale “generates 12-month earnings before interest, taxes, depreciation and amortization (EBITDA) of about $500 million and could be valued at about 10 times its EBITDA,” Reuters reported. AbbVie is reportedly interested in the sale of the women’s health assets in order to pay down some of the billions of dollars of debt associated with the Allergan acquisition. That would also free up some funds to focus on the development of new pharmaceutical products that will become financial drivers, particularly as its $20 billion per-year cash cow Humira, currently the best-selling pharmaceutical in the world, faces patent expiration in 2023. Two of those drugs that are likely to become key assets for AbbVie are the immunology drugs Skyrizi and Rinvoq, both of which have been seen as successors to Humira. Plaque psoriasis drug Skyrizi (risankizumab-rzaa) was approved by the U.S. Food and Drug Administration in 2019. Later that year, Rinvoq (upadacitinib), a JAK inhibitor, was approved by the FDA for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. In 2020, both drugs generated a combined $2.3 billion, according to an AbbVie filing with the U.S. Securities and Exchange Commission. Those revenues are likely to grow with approvals for additional indications. In fact, AbbVie boosted its sales estimates for the two drugs to $15 billion by 2025. Last year, Rinvoq, an oral treatment, hit the mark in a pivotal Phase III study in atopic dermatitis, as well as in moderate to severe ulcerative colitis. Also last year, Skyrizi bested Novartis’ Cosentyx in a Phase III plaque psoriasis study. Skyrizi demonstrated significantly higher rates of skin clearance compared to Cosentyx, with at least a 90% improvement from baseline. The increased revenue from Rinvoq and Skyrizi, as well as other milestones, resulted in a significant bump in compensation for Chief Executive Officer Richard Gonzales. According to the company’s SEC Filing, Gonzales took home $24,007,591 in total compensation for 2020. Gonzales’ take-home pay was a significant bump over the $21 million he took home in 2019. The bulk of the CEO’s compensation was from long-term equity awards, which came in at about $14.4 million. Featured Jobs on BioSpace