Teva Pharmaceutical Industries has filed an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market the generic version of Novo Nordisk's Victoza® (liraglutide) injection, in the U.S. Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Based on available information, Teva believes it is a "first applicant" to file an ANDA for the generic version of Victoza®; should its ANDA be approved, Teva may be entitled to 180 days of generic market exclusivity.
For the 12 months ending December 31, 2016, Victoza® had total U.S. sales of approximately $3.2 billion, according to IMS Health data.