Sector News

Novo Nordisk and Novartis put Victoza patent suit to bed, teeing up Sandoz copycat by 2024

March 27, 2022
Life sciences

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

Source: fiercepharma.com

comments closed

Related News

March 24, 2024

Johnson Matthey to sell its Medical Devices business for $700 million

Life sciences

Johnson Matthey Plc (JM; London) announced that it has signed a definitive agreement to sell 100% of its Medical Device Components business (MDC) to Montagu Private Equity (Montagu) for cash consideration of US$700 million (£550 million) on a cash free debt free basis.

March 24, 2024

Lonza acquires biologics manufacturing plant in California from Roche

Life sciences

Lonza AG (Basel, Switzerland) announced it has signed an agreement to acquire the Genentech large-scale biologics manufacturing site in Vacaville, Calif. from Roche (Basel, Switzerland) for $1.2 billion. The acquisition will significantly increase Lonza’s large-scale biologics manufacturing capacity.

March 24, 2024

Roquette to acquire IFF Pharma Solutions to boost global excipient presence

Life sciences

Roquette plans to acquire International Flavors & Fragrances (IFF) Pharma Solutions for an enterprise value of up to €2.85 billion (US$3.09 billion). With the acquisition set to close in the first half of 2025, the plant-based ingredient and pharmaceutical excipients supplier aims to reinforce its position in the pharmaceutical industry.

How can we help you?

We're easy to reach