Pharma Focus Europe

Glenmark Pharmaceuticals reaches settlement agreement with Pfizer for Axitinib Tablets, 1 mg and 5 mg

Wednesday, November 23, 2022

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.

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