Danish pharmaceutical company Novo Nordisk has reached an agreement with Teva Pharmaceuticals USA to settle the patent dispute in the US over its type 2 diabetes drug Victoza (liraglutide).
As part of the settlement, Teva can introduce a generic version of Victoza from 22 December 2023.
The company would only be able to launch its own Victoza generic before this date if Novo Nordisk’s patent were lifted or another company started to market a Victoza generic.
If Novo Nordisk secures six months paediatric extension for the drug, all these timeframes will be extended by six months.
The settlement agreement is subject to review by the US Federal Trade Commission and the US Department of Justice.
Novo Nordisk Biopharm and Legal Affairs executive vice-president and head Jesper Brandgaard said: “This settlement reflects the comprehensive US patent portfolio for liraglutide. Novo Nordisk will continue to defend our broad intellectual property portfolio for innovative drugs against challenges.”
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Available in pre‑filled pens, Victoza is indicated for once-daily use in conjunction with diet and exercise to improve glycaemic control in adults suffering from type 2 diabetes.
The medicine is an ‘incretin mimetic’ and belongs to a class of glucagon-like peptide-1 (GLP-1) receptor agonists. It works by increasing the amount of insulin generated by the pancreas in response to food. This mechanism is intended to help control blood glucose levels.
IMS Health statistics reveal that the drug recorded approximately $3.2bn in total US sales for the 12 months ending 31 December 2016.
According to data from six main clinical studies conducted in a total of 4,155 patients, Victoza demonstrated effectiveness in controlling the blood glucose.
The drug secured European Commission (EC) marketing authorisation in 2009, followed by the US Food and Drug Administration (FDA) approval in 2010. Teva Pharmaceutical Industries submitted an abbreviated new drug application (ANDA) to the FDA for approval of a generic version of Victoza in 2017.