After Teva Pharmaceutical snagged the OK to launch its Victoza generic in 2023, another copycat has secured a launch timeline for its generic to Novo Nordisk’s aging GLP-1 mainstay.
Novo Nordisk and Novartis’ Sandoz have settled a patent infringement lawsuit covering the Danish drugmaker’s diabetes blockbuster Victoza, according to court documents filed Tuesday in the U.S. District Court for the District of Delaware.
The companies reached an accord shortly before an April trial in Delaware federal court, Bloomberg Law first pointed out.
Under the agreement, Sandoz is cleared to launch its generic version of Victoza by June 22, 2024—or “earlier under certain circumstances,” a Novo Nordisk spokesperson told Fierce Pharma.
“This settlement reflects the comprehensive US patent portfolio for liraglutide,” Tomas Haagen, group general counsel and senior vice president of Novo Nordisk, added in the company’s emailed statement. “Novo Nordisk will continue to defend our broad intellectual property portfolio for innovative drugs against challenges,” he said.
Back in 2021, Moody’s analysts estimated Victoza’s patent protection would run out between 2022 and 2023, which lines up with Novo’s own word. Victoza’s active ingredient patent is set to lapse in the U.S. and Europe in 2023, the company said (PDF) in its 2021 annual report. Victoza’s active ingredient patent will expire in Japan in 2022, and it’s already run out in China, the company has noted.
Aside from Sandoz, generics juggernauts Teva Pharmaceutical and Viatris—formerly Mylan—also have Victoza copycats lined up. Novo in 2019 settled a patent dispute with Teva, keeping the Israeli-American pharma’s generic at bay until late 2023.
At the time, Novo pointed out that Teva’s prospective launch date would be delayed by six months, provided Novo scored pediatric exclusivity for Victoza. That same year, Victoza snagged an FDA label expansion to include kids and teens ages 10 to 17 with Type 2 diabetes.
That pediatric green light could delay Teva’s entry until early 2024, around the same time that Novartis’ copycat is due to grace the stage.
Meanwhile, in 2020, Mylan contested Victoza patent No. 8,114,833, covering the med’s manufacturing and formulation, which protects Novo’s diabetes drug through early 2026.
The companies had settled as of April 2021, according to online legal repository JD Supra, though it’s unclear exactly when Viatris’ generic will debut.
A Novo Nordisk spokesperson said the company couldn’t provide further color on the Victoza settlement landscape at this time.
Victoza generated 15 billion Danish krone ($2.2 billion) in 2021, Novo reported (PDF) in February. The drug now fits into the company’s wider GLP-1 repertoire comprising diabetes med Ozempic, its oral counterpart Rybelsus and obesity newcomer and blockbuster-in-waiting Wegovy.
Novo’s sales of GLP-1 meds for Type 2 diabetes jumped 32% at constant exchange rates last year to 53.6 billion Danish krone ($7.9 billion).
By Fraiser Kansteiner
In 2017, Sanofi partnered with the Lebanon, New Hampshire-based ImmuNext to develop an antibody for autoimmune diseases like lupus and multiple sclerosis, which included giving Sanofi a worldwide license to develop frexalimab. The agreement involved milestone payments upto $500 million.
Global manufacturer for the pharmaceutical, biotech and nutraceutical markets, Lonza has announced that it has acquired Synaffix, a biotech company focused on the commercialisation of its clinical stage technology platform for the development of antibody-drug conjugates (ADCs).
In its hunt for the new head of its pharmaceutical systems business—which makes syringes, self-injection systems and other drug delivery devices for 70% of the top 100 drugmakers in the world, according to the company—BD landed on a candidate with plenty of experience among that customer group.