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19 March 2019Americas

Teva enters settlement with Novo Nordisk to sell Victoza generic

Danish pharmaceutical company  Novo Nordisk and generics maker  Teva have reached a settlement in their US dispute over Victoza (liraglutide).

Under the settlement, Teva is now licenced to launch a generic version of Novo Nordisk’s drug Victoza, a noninsulin medication for type 2 diabetes, as of December 22, 2023.

Announced yesterday, March 18, the settlement is subject to review by the US Federal Trade Commission and the US Department of Justice.

In March 2017, Novo Nordisk accused Teva of patent infringement, after the generics maker filed an Abbreviated New Drug Application with the US Food and Drug Administration.

Jesper Brandgaard, executive vice president and head of biopharm and legal affairs at Novo Nordisk, said: “This settlement reflects the comprehensive US patent portfolio for liraglutide. Novo Nordisk will continue to defend our broad IP portfolio for innovative drugs against challenges.”

If the Victoza patents are invalidated or another generic hits the market sooner, Teva would be able to launch before December 2023. Under other undisclosed circumstances, Teva could launch after March 22, 2023.

Novo Nordisk added that if it was granted six months paediatric extension for Victoza, the above-mentioned timelines would be extended by six months.

Earlier this year, Teva  settled another patent dispute, this time with Amgen, over Teva’s generic cinacalcet HCI product. Teva’s product is a generic version of Amgen’s secondary hyperparathyroidism drug, Sensipar (cinacalcet HCl).

Under the terms of the agreement, Teva agreed to stop selling the generic drug until its licence date in 2021, or earlier under certain circumstances.

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More on this story

Big Pharma
4 January 2019   Teva Pharmaceuticals has announced that it has resolved a dispute with Amgen over Teva’s generic cinacalcet HCI product.
Generics
24 March 2022   Novo Nordisk and Sandoz have settled an ongoing patent dispute over the blockbuster diabetes treatment Victoza before the companies were meant to face trial in April.

More on this story

Big Pharma
4 January 2019   Teva Pharmaceuticals has announced that it has resolved a dispute with Amgen over Teva’s generic cinacalcet HCI product.
Generics
24 March 2022   Novo Nordisk and Sandoz have settled an ongoing patent dispute over the blockbuster diabetes treatment Victoza before the companies were meant to face trial in April.