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

January 22, 2023

Sun Pharma to buy Concert Pharmaceuticals for $576m

Life sciences

Sun Pharmaceutical Industries has signed a definitive agreement to buy all outstanding shares of Concert Pharmaceuticals in a deal valued at $576m. Under the deal, the company will buy all shares of Concert common stock through a tender offer for $8.00 per share in cash upfront payment.

January 22, 2023

Novo Nordisk diabetes pill wins FDA approval for first-line use

Life sciences

The Food and Drug Administration on Thursday approved Novo Nordisk’s diabetes pill Rybelsus as an initial treatment to lower blood sugar levels, a label expansion that will allow it to compete more directly with other oral drugs from Merck & Co. and Eli Lilly.

January 22, 2023

Bayer feeling more heat from activist investors, this time from Bluebell

Life sciences

Since making an ill-advised $63 billion buy of Monsanto in 2018, Bayer has faced heaps of pressure from investors that have called for the company to oust its leadership and to restructure. Now comes new pressure from a familiar source. Bluebell Capital Partners has bought an undisclosed stake in the company and is agitating for a breakup, sources told Reuters.

How can we help you?

We're easy to reach