Novo gets four-year reprieve in US from Teva’s Victoza copycats

By PharmaCompass

2019-03-21

Impressions: 133 Article

In the US, Novo Nordisk has got a reprieve of at least four years to build up its newer diabetes drugs before Teva Pharmaceuticals USA launches generic copies of its blockbuster drug Victoza. In a statement issued by Novo this week, the Danish drugmaker said it has reached a settlement with Teva on the US patent litigation case for Victoza (liraglutide). Consequently, Teva is licensed to launch a generic version of Victoza only after December 22, 2023.

“Under certain circumstances, Teva could launch a generic version of Victoza earlier, but not before March 22, 2023, unless the Victoza patents are no longer in force or there is another generic version of Victoza on the market. If Novo Nordisk is granted six months pediatric extension for Victoza, all above-mentioned timelines will be extended by six months,” Novo said in a statement.

That gives Novo time to grow its weekly GLP-1 (short for glucagon-like peptide 1) drug Ozempic, (semaglutide) approved in late 2017 as a follow-up to the daily Victoza, and its forthcoming oral version of the same drug before those newer medications face Victoza generics.

Novo is hoping to get oral semaglutide to the FDA within weeks, so that the approval comes in before the year-end.

The drugmaker has a lot riding on its new generation GLP-1 drugs, as competing drugs in the class — such as Eli Lilly’s Trulicity — eat into Victoza’s market share.

Victoza brought in US$ 2.67 billion for Novo last year, up 8 percent over the drug’s 2017 revenues. In comparison, Ozempic sales were US$ 273 million last year.

Teva has been challenging Novo’s patents and has been working towards launching its own version of Victoza since 2017. In February 2017, Teva said it filed an FDA application for a Victoza copycat and that it believed it was a “first filer,” which would make it eligible for 180 days of generic exclusivity.

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