Glenmark Pharmaceuticals Inc., USA (Glenmark) and Glenmark Pharmaceuticals Limited have reached a settlement agreement with Pfizer Inc., PF Prism C.V., and PF Prism IMB B.V. (Pfizer) for Axitinib Tablets, 1 mg and 5 mg, the generic version of their Inlyta®1 Tablets, 1 mg and 5 mg.
Glenmark had previously announced it received tentative approval by the United States Food & Drug Administration (U.S. FDA) for their generic Axitinib Tablets, 1 mg and 5 mg on November 30, 2020.
According to IQVIATM sales data for the 12‐month period ending September 2022, the Inlyta® Tablets, 1 mg and 5 mg market2 achieved annual sales of approximately $644.5 million*.
Glenmark’s current portfolio consists of 177 products authorized for distribution in the U.S. marketplace and 47 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings,
Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Glenmark Pharmaceuticals Ltd. is an innovation‐driven global pharmaceutical company with a presence across Specialty, Generics and OTC businesses. It focuses on the key therapeutic areas of respiratory, dermatology and oncology. The company has 10 world‐class manufacturing facilities spread across 4 continents and operations in over 80 countries. Glenmark is ranked among the world’s top 100 biopharmaceutical companies and among the world’s top 50 companies in the off‐patent sector