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.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2015 were $19.7 billion.
For more information, visit www.tevapharm.com.
February 02, 2017