Novo Nordisk Successfully Defends Intellectual Property: Reaches Patent Litigation Settlement with Teva, Delaying Victoza (Liraglutide) Generic Launch Until 2023
Mar 19, 2019 16:03
CST Updated
16:03
Novo Nordisk
Insulin Developer and Manufacturer
Teva
Drug Developer
FDA
U.S. Food and Drug Administration
March 19, 2019/BioonBIOON/-- Danish pharmaceutical giant Novo Nordisk recently announced that it has reached an agreement with Teva Pharmaceuticals USADiabetesThe U.S. patent litigation involving the drug Victoza (Chinese brand name: NovoForce; generic name: liraglutide) has been settled. Teva is authorized to launch its generic version of Victoza on December 22, 2023.
In certain circumstances, Teva may launch its generic version of Victoza earlier, but not before March 22, 2023, unless the patents for Victoza are no longer valid or another generic version of Victoza is already on the market. If Novo Nordisk is granted a six-month pediatric exclusivity extension for Victoza, the aforementioned timeline will be extended by six months. All other terms of this agreement are confidential.
The agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. Jesper Brandgaard, Executive Vice President and Head of Biopharmaceuticals and Legal Affairs at Novo Nordisk, stated, “This solution reflects the extensive U.S. patent portfolio for liraglutide. Novo Nordisk will continue to defend our innovative medicines’ broadIntellectual Propertyportfolio, and address challenges.”
Victoza (Novo Nordisk) belongs to the class of glucagon-like peptide-1 (GLP-1) receptor agonist hypoglycemic drugs. It was approved in the Chinese market in April 2011 and launched in October of the same year. The active pharmaceutical ingredient of Victoza is liraglutide, a GLP-1 analog that stimulates the secretion of natural insulin. GLP-1 is a hormone secreted by small intestinal cells, which promotes insulin secretion and inhibits glucagon secretion after meals to accelerate glucose metabolism, while also delaying gastric emptying and suppressing appetite.
In August 2017, Victoza was approved by the U.S.FDAApproval of a new indication, becoming the world’s first to significantly reduce cardiovascular risk in high-risk type 2DiabetesGLP-1 receptor agonists for the risk of cardiovascular death in patients. In clinical studies, liraglutide not only significantly improves glycemic control but also effectivelyWeight Lossand improve obesity-related comorbidities. Based on these findings, Novo Nordisk has successfully developed liraglutide into aWeight LossSaxenda injection.
According to Novo Nordisk’s 2018 annual report, global sales of Victoza reached DKK 2.4333 billion (approximately USD 3.7 billion), representing a 5% increase from 2017 (DKK 2.3173 billion). (Bioon.com)