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.

Two years before the first biosimilars to megablockbuster Humira are expected to hit the US market, AbbVie is taking one developer to court over allegations it stole trade secrets to create its copycat version. AbbVie has filed suit against Icelandic biotech Alvotech for “injunctive relief and recovery of damages,” according to court documents dated Friday. The pharma accuses Alvotech of embarking on an “unlawful plot to surreptitiously take AbbVie’s confidential and proprietary trade secrets.” The alleged scheme revolves around the hiring of Rongzan Ho, a former AbbVie team leader of Humira’s upstream manufacturing. In its complaint, AbbVie says Ho attempted three times to email “trade secret information” about the large-scale manufacturing of Humira to his personal account before leaving the company for Alvotech. The first two tries were blocked by the company’s security system, AbbVie alleges. But the third — an email titled “Keep in touch (AbbVie)” — was successful, according to the court documents. AbbVie says Ho “affirmatively misrepresented” that he had expunged all AbbVie information from any devices, including his computer, external storage device, email or cloud storage upon leaving the job. The company also accused Alvotech of continuing to recruit AbbVie employees with “intimate knowledge” of Humira’s manufacturing process, adding that two additional staffers were hired last May. “Unless enjoined, Alvotech’s illegal actions will serve as a roadmap to use AbbVie’s trade secrets for both Alvotech and other companies that have not adequately invested in their own independent research and development,” the complaint reads. Alvotech wrote in an email to Endpoints News that it “strongly disputes” the allegations, adding it’s been three years since the “purported date of the alleged wrongdoing,” and the employee in question no longer works for Alvotech. “Alvotech will vigorously defend against these allegations,” a spokesperson said. A host of critics, including US lawmakers, have called AbbVie out in the past for its patent-aggressive approach with Humira. This past June, a US judge ruled in favor of AbbVie against allegations that it engaged in anticompetitive conduct to elbow out rivals. When AbbVie’s main patent for Humira ran out in 2016, the company applied for a raft of new patents — a move that was further strengthened by agreements with Amgen, Samsung Bioepis, and Novartis’ Sandoz to keep biosimilars off the US market until 2023, that complaint said. Back in August, AbbVie paid $24 million to settle a lawsuit brought forth by California’s insurance regulator, alleging that AbbVie bribed and rewarded physicians for Humira prescriptions. While AbbVie denied the claims, it agreed to look into how Humira is marketed in the state, according to a Reuters report. With the clock ticking on Humira, AbbVie has started making the case for its newer meds. Back in January, the company read out new Phase III data for its IL-23 Skyrizi, which showed the drug beat a placebo at reducing psoriatic arthritis patients’ symptoms from baseline after six months of treatment. Reports surfaced earlier this month that AbbVie is also considering selling off the $5 billion women’s health portfolio it acquired from Allergan, in order to pay off debt and focus on new areas. Unnamed sources told Reuters that AbbVie was working with Morgan Stanley to auction off the portfolio, which includes the Lo Loestrin Fe birth control pill. But when Endpoints News reached out for confirmation, a spokesperson replied: “We don’t comment on rumors.”