Lupin`s Generic Pitavastatin Calcium Receives Approval in the U.S.
MAPLE GROVE, Minn. , Nov. 6, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Pitavastatin Tablets in 1 mg, 2 mg, and 4 mg strengths. The Pitavastatin Tablet market had U.S. sales of approximately $302 million for the 12 months ending August 2023 according to IQVIA. Pitavastatin Tablets are an AB-rated, generic equivalent to the brand product, LIVALO® (pitavastatin) tablets.*
Indian Pharmaceutical companies and their subsidiaries have established strong presence in US during last couple of years with higher ANDA approvals. The loss of patent exclusivity and cost cutting measures adopted by several nations pushed the demand for generic segment. Indian pharma companies enhanced their investments in research and development (R&D) and successfully received higher approvals from US FDA during last decade. Out of total 5,350 ANDA approvals between 2009 to 2018, Indian companies have secured 34.4% of these approvals and received total 1,842 ANDA final approvals. Further, out of total 1,310 tentative approvals, Indian companies grab 500 tentative approvals from US FDA which worked out to over 38.2%.
Medicure (TSXV:MPH) today announced that pitavastatin magnesium (ZYPITAMAGTM) tablets are now available in retail pharmacies throughout the United States. ZYPITAMAGTM, a statin (HMG-CoA reductase inhibitor) medication approved by the U.S. Food and Drug Administration (FDA) in July 2017, is available in strengths of 1 mg, 2 mg and 4 mg. ZYPITAMAGTM is indicated for the treatment of patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet, to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). (Refer to the annexure appended below for the complete indication statement and important safety information.)
Japanese drugmaker Kowa Co. Ltd. won a patent infringement trial against Amneal and Apotex on Wednesday when a New York federal judge delivered the verdict that Kowa’s patent for the statin Livalo was valid and that the defendants were not able to show it was anticipated or obviou
Drug firm LupinBSE -0.25 % has received approval from the US health regulator to market Pitavastatin tablets used for lowering cholesterol.