Company: Novo Nordisk
2020 sales: $3 billion
Key patent expirations: 2022 to 2023
Danish diabetes giant Novo Nordisk has spent the past few years revving up its semaglutide franchise ahead of Victoza's tumble off the patent cliff.
With combined sales of its newer GLP-1 drug Ozempic and that med's oral counterpart Rybelsus clocking in at close to $4 billion last year, Novo's well on its way. But it still has plenty of work to do before Victoza generics grace the stage in the coming years.
Victoza, first approved in 2010, has been narrowly eclipsed by Ozempic on the sales front. The drug generated 18.74 billion Danish kroner (about $3 billion) in 2020 compared with Ozempic's $3.42 billion. Meanwhile, oral diabetes med Rybelsus, approved toward the end of 2019, ginned up roughly $300 million for the year.
While still a ways out from blockbusterland, Rybelsus' star is on the rise. In 2021's first quarter, Rybelsus sales leaped a stunning 247% at constant exchange rates versus the same period in 2020, Novo reported in early May.
Moody's analysts predict Victoza's patent protection will lapse in the 2022 to 2023 timeframe, which tracks with Novo's own word. In its 2020 annual report, the company said Victoza's active ingredient patent would expire in Japan next year, and in 2023 in the U.S. and Germany. Victoza's active ingredient patent has already run out in China, the company said.
But the company might not face copycats right when the key patents expire.
Back in March 2019, Novo settled a patent dispute with Israeli generics outfit Teva Pharmaceutical to stave off copycats until late 2023. Novo at the time pointed out that Teva's prospective launch date would be delayed by six months if Novo scored pediatric exclusivity for Victoza. In June of that year, the FDA expanded Victoza's approval to include kids and teens ages 10 to 17 with Type 2 diabetes.
That FDA approval could push Teva's entry into early 2024, and it remains unclear whether other copycats would launch before then.
The Teva patent feud had been brewing since at least 2017 when the generics giant filed its FDA application for a Victoza copycat. Believing itself to be a "first filer," Teva set its sights on the 180-day generic exclusivity that distinction entails.
Mylan, which has since become Viatris, has also proved to be a thorn in Victoza's side. Last year, Mylan sought to challenge Victoza patent No. 8,114,833, which covers the drug's formulation and manufacturing. Mylan claimed the patent wasn't valid because it relates to an obvious invention. The patent covers Novo's GLP-1 blockbuster through early 2026.
After hearing initial arguments, the U.S. Patent Trial and Appeal Board, which launched an inter partes review on the patent, found a “reasonable likelihood” Mylan would prove triumphant in the case. As of April 2021, the companies had settled, according to online legal repository JD Supra. Following that deal, it isn't clear exactly when Viatris' Victoza copycat will launch.
Elsewhere on the GLP-1 front, Novo has been all-in on semaglutide, whether that's Ozempic, Rybelsus or, most recently, its newly-minted obesity med Wegovy. Wegovy, also known as semaglutide 2.4 mg, won its coveted green light in early June thanks to impressive trial data.
Novo also has an oral version of Wegovy in the works, and it recently refiled its application for a higher dose of Ozempic.