Glenmark Pharmaceuticals on Tuesday announced that it has reached a settlement agreement with Pfizer for Axitinib Tablets, 1 mg and 5 mg, the generic version of their Inlyta Tablets, 1 mg and 5 mg.
Axitinib, developed by Pfizer, is used alone to treat advanced renal cell carcinoma and it has been shown to significantly inhibit the growth of breast cancer in animal models.
According to the company’s statement, 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, it claimed.
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