Teva Pharmaceutical Industries Ltd., announced that it 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.
With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market. Teva has over 300 product registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in six generic prescriptions dispensed in the U.S. is filled with a Teva generic product.