Viatris plans for Ozempic, Wegovy generics amid lawsuit from Novo Nordisk

Viatris Pharmaceuticals’ applications for generic options for type 2 diabetes drug Ozempic and weight loss drug Wegovy are now under regulatory review, according to the company’s second quarter presentation.

If approved, both would be the first generics to market for the blockbuster drugs.

But Novo Nordisk has already taken steps to stop Viatris from bringing a Wegovy generic to market with a lawsuit filed in January in Delaware District Court. In court filings, lawyers for Novo wrote that the lawsuit comes from Viatris’ submission of an abbreviated NDA to the FDA for a Wegovy generic injection prior to the patents’ expiration.

Novo wrote in court filings that it received notice of Viatris’ asserted patents in December and that the abbreviated NDA “essentially copies” the Wegovy label and formulation. The company added that Novo will be “irreparably harmed” if Viatris isn’t stopped from infringing on the patents. Novo has asked for a permanent injunction against the patent infringement as well as damages if the generic is commercialized.

Viatris and Mylan’s lawyers, for their part, denied allegations of patent infringement and said they were seeking approval from the FDA for semaglutide injections of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg single-dose prefilled pens.

Viatris was formed out of a $12 billion merger between Mylan and Pfizer’s Upjohn unit back in 2020. It has faced other litigation from Novo Nordisk as well, agreeing not to launch a generic version of Victoza (liraglutide), another type 2 diabetes drug, until June 2024.

Wegovy and Ozempic are two of 13 complex injectables the company is working on bringing to market with a hopeful forecast of $1 billion in annual peak net sales in 2027.

Rajiv Malik

“We should be looking into launching these products, if we are optimistic, later this year or early next year,” Viatris President Rajiv Malik told investors on Monday’s call. “From then onwards, I think every year, you will see two to three key products getting launched.”

A week ago, Viatris launched its generic of AstraZeneca’s blockbuster asthma and COPD drug Symbicort, which brought in $2.5 billion for the pharma giant in 2022. Viatris teamed up with Kindeva Drug Delivery to launch its inhalant Breyna, a complex drug-device combo that marks the first outside generic to come to market to compete with Symbicort.

Viatris is also working with Mapi Pharma and submitted an ANDA to FDA for a once-monthly, long-acting glatiramer acetate injection for the treatment of relapsing forms of multiple sclerosis. The FDA will make a decision by March 8, 2024.

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